Dodine (CASRN 2439-10-3)
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0234
Dodine;
CASRN 2439-10-3
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 Dodine
File First On-Line 09/30/1987
Category (section) |
Status |
Last Revised |
---|---|---|
Oral RfD Assessment (I.A.) | on-line | 09/01/1990 |
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 — Dodine
CASRN — 2439-10-3
Last Revised — 09/01/1990
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 |
---|---|---|---|---|
Thyroid toxicity 1-Year Dog Feeding American Cyanamid, 1958 |
NOEL: 50 ppm diet LEL: 200 ppm diet |
300
|
1
|
4E-3
mg/kg/day |
*Conversion Factors -- 1 ppm = 0.025 mg/kg/day (assumed dog food consumption)
__I.A.2. Principal and Supporting Studies (Oral RfD)
American Cyanamid Company. 1958. MRID No. 0082516. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
Two beagle dogs/sex were exposed in the diet to 0, 50, 200, or 800 ppm of technical dodine for 1 year. Exposure related effects, at 800 ppm, were changes in the shape of follicular epithelial cells of the thyroid from squamous to cuboidal and low columnar in 4/4 dogs; increased vascularity; and partially filled follicles that stained less intensely. Milder changes of the same kind in 1 dog of 4 given 200 ppm were seen, and thus 50 ppm is considered the NOEL. The study was rated core grade supplementary for chronic nonrodent feeding study because of the small number of dogs.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — An uncertainty factor of 100 was used to account for inter- and intraspecies differences. An additional UF of 3 was used to allow for the uncertainty caused by existing data gaps in teratogenicity, the supplementary dog study, and the inadequate histopathology in the chronic rat study.
MF — None
__I.A.4. Additional Studies/Comments (Oral RfD)
Data Considered for Establishing the RfD:
1) 1-Year Feeding - dog: Principal study - see previous description; core grade supplementary
2) 2-Year Feeding - rat: NOEL=200 ppm (7-10 mg/kg/day); LEL=800 ppm (29-45 mg/kg/day) (decreased weight gain in males, females; reduced food consumption in males); core grade supplementary (American Cyanamid Co., 1959)
3) 3-Generation Reproduction - mouse: Fetotoxic NOEL=none; LEL=(74-89 mg/kg/day) (LDT; decreased viability and lactation indices in two matings of the third generation); Reproductive and Parental NOEL=800 ppm (120 mg/kg/day) (HDT); Reproductive and Parental LEL=none; core grade supplementary (American Cyanamid, 1967)
4) 2-Generation Reproduction - rat: Reproductive NOEL=800 ppm (40 mg/kg/day) (ODT); LEL=none; Fetotoxic LEL=800 ppm (reduced number pups/litter); Parental NOEL=none; Parental LEL=800 ppm (40 mg/kg/day) (decreased weight gain, decreased food consumption); core grade supplementary (American Cyanamid, 1958b)
Data Gap(s): Chronic Rat Feeding Study; Chronic Dog Feeding Study; Rat Teratology Study; Rabbit Teratology Study
__I.A.5. Confidence in the Oral RfD
Study — Low
Database — Low
RfD — Low
The principal study is valid but of low sensitivity because of a small number of animals. It is given a low confidence rating. The database on chronic toxicity is likewise incomplete, thus, it is given a low confidence rating. Low confidence in the RfD follows.
__I.A.6. EPA Documentation and Review of the Oral RfD
Pesticide Registration Standard, 1986
Pesticide Registration Files
Agency Work Group Review — 10/28/1986, 03/18/1987
Verification Date — 03/18/1987
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 Dodine conducted in November 2001 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 — Dodine
CASRN — 2439-10-3
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Dodine
CASRN — 2439-10-3
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 — Dodine
CASRN — 2439-10-3
Last Revised — 09/01/1990
_VI.A. Oral RfD References
American Cyanamid Company. 1958a. MRID No. 00082516. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
American Cyanamid Company. 1958b. MRID No. 00058714. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
American Cyanamid Company. 1959. MRID No. 00082517. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
American Cyanamid Company. 1967. MRID No. 00058715. Available from EPA. Write to FOI, EPA, Washington, DC 20460.
_VI.B. Inhalation RfD References
None
_VI.C. Carcinogenicity Assessment References
None
_VII. Revision History
Substance Name — Dodine
CASRN — 2439-10-3
Date |
Section |
Description |
---|---|---|
09/01/1990 | I.A.4. | Citations added |
09/01/1990 | VI. | Bibliography on-line |
01/01/1992 | IV. | Regulatory Action section 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 — Dodine
CASRN — 2439-10-3
Last Revised — 09/30/1987
- 2439-10-3
- AC 5223
- APADODINE
- CARPENE
- CURITAN
- CYPREX
- CYPREX 65W
- DODECYLGUANIDINE ACETATE
- n-DODECYLGUANIDINE ACETATE
- DODIN
- Dodine
- DODINE ACETATE
- DOGUADINE
- DOQUADINE
- ENT 16,436
- GUANIDINE, DODECYL-, ACETATE
- LAURYLGUANIDINE ACETATE
- MELPREX
- MILPREX
- N-DODECYLGUANIDINACETAT
- SYLLIT
- TSITREX
- VENTUROL
- VONDODINE