Vinclozolin (CASRN 50471-44-8)
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0126
Vinclozolin;
CASRN 50471-44-8
Health assessment information on a chemical substance is included in IRIS
only after a comprehensive review of chronic toxicity data by U.S. EPA
health scientists from several Program Offices and the Office of Research
and Development. The summaries presented in Sections I and II represent
a consensus reached in the review process. Background information and
explanations of the methods used to derive the values given in IRIS are
provided in the Background Documents.
STATUS OF DATA FOR Vinclozolin
File First On-Line 01/31/1987
Category (section) |
Status |
Last Revised |
---|---|---|
Oral RfD Assessment (I.A.) | on-line | 01/01/1992 |
Inhalation RfC Assessment (I.B.) | no data | |
Carcinogenicity Assessment (II.) | no data |
_I. Chronic Health Hazard Assessments for Noncarcinogenic Effects
_I.A. Reference Dose for Chronic Oral Exposure (RfD)
Substance Name — Vinclozolin
CASRN — 50471-44-8
Last Revised — 01/01/1992
The oral Reference Dose (RfD) is based on the assumption that thresholds
exist for certain toxic effects such as cellular necrosis. It is expressed
in units of mg/kg-day. In general, the RfD is an estimate (with uncertainty
spanning perhaps an order of magnitude) of a daily exposure to the human
population (including sensitive subgroups) that is likely to be without
an appreciable risk of deleterious effects during a lifetime. Please refer
to the Background Document for an elaboration of these concepts. RfDs
can also be derived for the noncarcinogenic health effects of substances
that are also carcinogens. Therefore, it is essential to refer to other
sources of information concerning the carcinogenicity of this substance.
If the U.S. EPA has evaluated this substance for potential human carcinogenicity,
a summary of that evaluation will be contained in Section II of this file.
__I.A.1. Oral RfD Summary
Critical Effect |
Experimental Doses* |
UF |
MF |
RfD |
---|---|---|---|---|
Organ weight changes 6-Month Feeding Dog |
NOEL: 100 ppm LEL: 300 ppm |
100 |
1 |
2.5E-2 mg/kg/day |
*Dose Conversion Factors & Assumptions: 1 ppm = 0.025 mg/kg/day (assumed dog food consumption)
__I.A.2. Principal and Supporting Studies (Oral RfD)
BASF Wyandotte Corporation. 1982. MRID No. 00110446; HED Doc. No. 002214.
Available from EPA. Write to FOI, EPA, Washington D.C. 20460.
Vinclozolin was administered in the diet to 6 dogs/sex/group at levels of 0
(controls), 100, 300, 600, and 2000 ppm for 6 months. Toxic effects were
noted at 300 ppm and consisted of significant increases in absolute and
relative adrenal weights in male and females. This diagnosis was supported by
the absolute and relative weight increases of the adrenals at 600 ppm and 2000
ppm and accompanied by histological findings. In females at 600 ppm and above
there was vacuolation of the zona fasciculata and birefringence of the cortex
in the adrenal. In males at 2000 ppm, the adrenal showed vacuolation of the
zona fasciculata. In male dogs at 300 ppm and above, a decrease in absolute
kidney weights was noted, and at 600 ppm and above the kidneys showed fat
droplets in the distal tubules.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — An uncertainty factor of 100 was used to account for the inter- and
intraspecies differences. The 6-month dog study is of marginal duration to
qualify as a long-term study. An additional UF of 10 to account for the lack
of a "chronic" dog study (at least 1 year) was not considered necessary, since
1) the other toxicologic studies on vinclozolin generally did not indicate
that the toxicologic endpoints would be seen at lower doses with extended
exposure, 2) the effects seen at the LEL in the 6-month dog study are of a
minor toxicologic nature, and 3) the dog is the most sensitive species tested
by far.
MF — None
__I.A.4. Additional Studies/Comments (Oral RfD)
Data Considered for Establishing the RfD
1) 6-Month Feeding - dog: Principal study - see discussion above; core grade
minimum
2) 103-Week Feeding (Oncogenic) - rat: Systemic NOEL=486 ppm (24.3
mg/kg/day), Systemic LEL=1458 ppm (72.9 mg/kg/day) (body weight reduction,
reduced serum bilirubin); no core grade (BASF Wyandotte Corp., 1977a)
3) 3-Generation Reproduction - rat: NOEL=1458 ppm (72.9 mg/kg/day) (HDT);
Teratogenic NOEL=1458 ppm (HDT); no core grade (BASF Wyandotte Corp., 1977b)
4) Teratology - rabbit: NOEL=300 mg/kg/day (HDT); Fetotoxic NOEL=80
mg/kg/day; Teratogenic NOEL=300 mg/kg/day (HDT); core grade minimum (BASF
Wyandotte Corp., 1981)
5) Teratology - mice: Teratogenic NOEL=6000 ppm (900 mg/kg/day); Fetotoxic
LEL=6000 ppm (resorptions); no core grade (BASF Wyandotte Corp., 1975)
Other Data Reviewed
1) 26-Month Feeding (Oncogenic) - mouse: Systemic NOEL=486 ppm (72.9
mg/kg/day); Systemic LEL=1458 ppm (7219 mg/kg/day) (decrease body weight gain
in males); core grade minimum (BASF Wyandotte Corp., 1977)
Data Gap(s): None
__I.A.5. Confidence in the Oral RfD
Study — High
Database — High
RfD — High
The critical study is of high quality and is given a high confidence rating. The other studies are also of good quality; thus, the database is given a high confidence rating. High confidence in the RfD follows.
__I.A.6. EPA Documentation and Review of the Oral RfD
Pesticide Registration Files
Agency Work Group Review — 07/08/1986
Verification Date — 07/08/1986
Screening-Level Literature Review Findings — A screening-level review conducted by an EPA contractor of the more recent toxicology literature pertinent to the RfD for Vinclozolin conducted in September 2002 identified one or more significant new studies. IRIS users may request the references for those studies from the IRIS Hotline at hotline.iris@epa.gov or (202)566-1676.
__I.A.7. EPA Contacts (Oral RfD)
Please contact the IRIS Hotline for all questions concerning this assessment or IRIS, in general, at (202)566-1676 (phone), (202)566-1749 (FAX) or hotline.iris@epa.gov (internet address).
_I.B. Reference Concentration for Chronic Inhalation Exposure (RfC)
Substance Name — Vinclozolin
CASRN — 50471-44-8
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Vinclozolin
CASRN — 50471-44-8
This substance/agent has not undergone a complete evaluation and determination under US EPA's IRIS program for evidence of human carcinogenic potential.
_III.
[reserved]
_IV. [reserved]
_V. [reserved]
_VI. Bibliography
Substance Name — Vinclozolin
CASRN — 50471-44-8
Last Revised — 01/01/1992
_VI.A. Oral RfD References
BASF Wyandotte Corporation. 1975. MRID No. 00062644; HED Doc. No. 000244.
Available from EPA. Write to FOI, EPA, Washington, DC 20460.
BASF Wyandotte Corporation. 1977a. MRID No. 00070036; HED Doc. No. 000244.
Available from EPA. Write to FOI, EPA, Washington, DC 20460.
BASF Wyandotte Corporation. 1977b. MRID No. 00062645; HED Doc. No. 000244.
Available from EPA. Write to FOI, EPA, Washington, DC 20460.
BASF Wyandotte Corporation. 1977c. MRID No. 00070037; HED Doc. No. 000244,
001885, 002717, 002669. Available from EPA. Write to FOI, EPA, Washington,
DC 20460.
BASF Wyandotte Corporation. 1981. MRID No. 00085079; HED Doc. No. 002409.
Available from EPA. Write to FOI, EPA, Washington, DC 20460.
BASF Wyandotte Corporation. 1982. MRID No. 00110446; HED Doc. No. 002214.
Available from EPA. Write to FOI, EPA, Washington, DC 20460.
_VI.B. Inhalation RfC References
None
_VI.C. Carcinogenicity Assessment References
None
_VII. Revision History
Substance Name — Vinclozolin
CASRN — 50471-44-8
Date |
Section | Description |
---|---|---|
03/01/1988 | I.A.4. | Text added |
03/01/1988 | I.A.5. | Confidence levels revised |
01/01/1992 | I.A.4. | Citations added |
01/01/1992 | IV. | Regulatory Action section on-line |
01/01/1992 | VI. | Bibliography on-line |
04/01/1997 | III., IV., V. | Drinking Water Health Advisories, EPA Regulatory Actions, and Supplementary Data were removed from IRIS on or before April 1997. IRIS users were directed to the appropriate EPA Program Offices for this information. |
12/03/2002 | I.A.6. | Screening-Level Literature Review Findings message has been added. |
_VIII. Synonyms
Substance Name — Vinclozolin
CASRN — 50471-44-8
Last Revised — 01/31/1987
- 50471-44-8
- BAS 35202F
- BAS 35204
- BAS352-04F
- Ronilan
- Vinclozolin