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Toxicological information

Toxicity to reproduction

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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:
2008

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

Constituent 1
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

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.