Chloramben (CASRN 133-90-4)
view QuickView

0023
Chloramben; CASRN 133-90-4
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 Chloramben
File First On-Line 01/31/1987
Category (section) |
Status |
Last Revised |
---|---|---|
Oral RfD Assessment (I.A.) | on-line | 03/01/1988 |
Inhalation RfC Assessment (I.B.) | no data | 09/01/1992 |
Carcinogenicity Assessment (II.) | no data |
_I. Chronic Health Hazard Assessments for Noncarcinogenic Effects
_I.A. Reference Dose for Chronic Oral Exposure (RfD)
Substance Name — Chloramben
CASRN — 133-90-4
Last Revised — 03/01/1988
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
|
---|---|---|---|---|
Hepatocyte degeneration 18-Month Feeding Study in CD-1 Mice Union Carbide, 1978 |
NOEL: none LEL: 100 ppm diet |
1000
|
1
|
1.5E-2
mg/kg/day |
*Conversion Factors -- 1 ppm = 0.15 mg/kg/day (assumed mouse food consumption)
__I.A.2. Principal and Supporting Studies (Oral RfD)
Union Carbide Agricultural Products Company, Inc. 1978. MRID No. 00040392, 00040398. Available from EPA. Write for FOI, EPA, Washington DC 20460.
Five hundred (250 male and 250 female) Crl:COBS CD-1 mice (approximately 4 weeks of age) were assigned 50/sex/group, to one control and three test groups. The test groups were fed diets containing the following levels of chloramben: 100, 1000, and 10,000 ppm. All animals were observed once a day for signs of illness or toxicity. All animals found dead or in extremis were subjected to gross necropsy examination. After 18 months, surviving animals were sacrificed. Nonneoplastic lesions were mainly observed in the liver and included hepatocyte degeneration.
__I.A.3. Uncertainty and Modifying Factors (Oral RfD)
UF — An uncertainty factor of 100 was used to account for the inter- and intra-species differences. An additional UF of 10 was used to account for the fact that a NOEL was not established.
MF — None
__I.A.4. Additional Studies/Comments (Oral RfD)
Data Considered for Establishing the RfD
- 18-Month Oncogenic (dietary) - Principal study - see description above; core grade supplementary
- Teratology - rat: Fetotoxic NOEL=500 ppm (25 mg/kg/day); Fetotoxic LEL=1500 ppm (75 mg/kg/day) (reduced ossification of skeletal bones); Maternal and Teratogenic NOEL=4500 ppm (HDT); core grade minimum (Union Carbide, 1976)
- 2-Year Feeding - rat: Systemic NOEL=1000 ppm (50 mg/kg/day); no core grade (Union Carbide, 1963a)
- 2-Year Feeding - dog: Systemic NOEL=10,000 ppm (250 mg/kg/day) (HDT); no core grade (Union Carbide, 1963b)
- 3-Generation Reproduction - rat: Systemic NOEL=4500 ppm (225 mg/kg/day) (HDT); Reproductive NOEL=4500 ppm (HDT); no core grade (Union Carbide, 1966)
Data Gap(s): Rabbit Teratology Study
Other Data Reviewed
1) 80-Week Oncogenic - mice: Systemic NOEL=20,000 ppm (300 mg/kg/day); core grade supplementary (NCI, 1977)
__I.A.5. Confidence in the Oral RfD
Study — Medium
Database — Medium
RfD — Medium
The principal study appears to be of acceptable quality and is given a medium confidence rating. Since there is a data gap existing for chloramben and other studies do not show effects at much higher dose levels, confidence in the database can be considered medium to low. Confidence in the RfD can also be considered medium to low.
__I.A.6. EPA Documentation and Review of the Oral RfD
Pesticide Registration Standard, July 1981
Pesticide Registration Files
Agency Work Group Review — 06/24/1986
Verification Date — 06/24/1986
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 Chloramben conducted in August 2003 did not identify any critical new studies. IRIS users who know of important new studies may provide that information to 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 — Chloramben
CASRN — 133-90-4
Not available at this time.
_II. Carcinogenicity Assessment for Lifetime Exposure
Substance Name — Chloramben
CASRN — 133-90-4
Not available at this time.
_III.
[reserved]
_IV. [reserved]
_V. [reserved]
_VI. Bibliography
Substance Name — Chloramben
CASRN — 133-90-4
Last Revised — 11/01/1989
_VI.A. Oral RfD References
NCI (National Cancer Institute). 1977. Bioassay of chloramben for possible carcinogenicity. U.S. DHEW Pub. No. (NIH) 77-825, Bethesda, MD.
Union Carbide Agricultural Products Company, Inc. 1963a. MRID No. 00100200, 00104543, 00104548. Available from EPA. Write for FOI, EPA, Washington DC 20460.
Union Carbide Agricultural Products Company, Inc. 1963b. MRID No. 00100201, 00139708. Available from EPA. Write for FOI, EPA, Washington DC 20460.
Union Carbide Agricultural Products Company, Inc. 1966. MRID No. 00100202. Available from EPA. Write for FOI, EPA, Washington DC 20460.
Union Carbide Agricultural Products Company, Inc. 1976. MRID No. 00096618. Available from EPA. Write for FOI, EPA, Washington DC 20460.
Union Carbide Agricultural Products Company, Inc. 1978. MRID No. 00040392, 00040398. Available from EPA. Write for FOI, EPA, Washington DC 20460.
_VI.B. Inhalation RfC References
None
_VI.C. Carcinogenicity Assessment References
None
_VII. Revision History
Substance Name — Chloramben
CASRN — 133-90-4
Date |
Section |
Description |
---|---|---|
03/31/1987 | IV. | Regulatory Action Section on-line |
03/01/1988 | I.A.5. | Confidence levels revised |
11/01/1989 | VI. | Bibliography on-line |
01/01/1992 | IV. | Regulatory action updated |
09/01/1992 | I.B. | Inhalation RfC now under review |
08/01/1995 | I.B. | EPA's RfD/RfC and CRAVE workgroups were discontinued in May, 1995. Chemical substance reviews that were not completed by September 1995 were taken out of IRIS review. The IRIS Pilot Program replaced the workgroup functions beginning in September, 1995. |
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. |
10/28/2003 | I.A.6. | Screening-Level Literature Review Findings message has been added. |
_VIII. Synonyms
Substance Name — Chloramben
CASRN — 133-90-4
Last Revised — 01/31/1987
- 133-90-4
- ACP-M-728
- AMBIBEN
- AMIBEN
- AMIBEN DS
- AMIBIN
- 3-AMINO-2,5-DICHLOROBENZOIC ACID
- AMOBEN
- BENZOIC ACID, 3-AMINO-2,5-DICHLORO-
- CHLORAMBED
- Chloramben
- CHLORAMBENE
- 2,5-DICHLORO-3-AMINOBENZOIC ACID
- NCI-C00055
- VEGABEN
- VEGIBEN