Registration Dossier
Registration Dossier
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EC number: 203-581-0 | CAS number: 108-42-9
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Parent screening
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- other: study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
- Principles of method if other than guideline:
- The study was designed to investigate the maternal reproductive effects of 3,4-Dichloroaniline in Charles River CrI:CD BR rats by oral (gavage) route.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3,4-dichloroaniline
- EC Number:
- 202-448-4
- EC Name:
- 3,4-dichloroaniline
- Cas Number:
- 95-76-1
- IUPAC Name:
- 3,4-dichloroaniline
- Details on test material:
- - Name of test material :3,4-dichloroaniline
- Molecular formula :C6H5Cl2N
- Molecular weight :162.01
- Substance type:organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CrI:CD BR
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Days 6 through 15 of gestation.
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5, 25 or 125 mg/kg bw.
Basis:
- Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- BODY WEIGHT: Yes
FOOD CONSUMPTION : Yes
OTHER:
Examinations included:
- Number of implantations: Yes
- Number of absorption: Yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- Increase in absorptions and consequently in post-implantation loss at 125 mg/kg.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 25 other: mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No statistically significant or toxicologically relevant adverse effects on any of the maternal reproductive parameters studied were observed in the 25 mg/kg dose groups.
- Remarks on result:
- other: not specified
- Dose descriptor:
- LOAEL
- Effect level:
- 125 other: mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: The test article did, however, produce a slight (though not statistically,,significant)increase in absorptions and consequently in post-implantation loss at 125 mg/kg.
- Remarks on result:
- other: not specified
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for maternal toxicity study was considered to be 25 mg/kg whereas LOAEL was considered to be 125 mg/kg in Charles River CrI:CD BR rats when 3,4-dichloroaniline was administered orally by gavage.
- Executive summary:
In this study, 3,4-dichloroaniline (CAS No : 95-76-1) was administered orally by gavage at three doses - 5, 25 and 125 mg/kg - to groups of pregnant Charles River CrI:CD BR rats.No statistically significant or toxicologically relevant adverse effects on any of the maternal reproductive parameters studied were observed in the 5 and 25 mg/kg dose groups.The test article did, however, produce a slight increase in absorptions and consequently in post-implantation loss at 125 mg/kg. Hence, NOAEL for maternal toxicity study was considered to be 25 mg/kg bw whereas LOAEL was considered to be 125 mg/kg in Charles River CrI:CD BR rats when 3,4-dichloroaniline was administered orally by gavage.
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