3-chloroaniline

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

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 teratogenic 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

Test material information

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

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

Duration of test:

15 days of gestation

Doses / concentrations

Remarks:

Doses / Concentrations:
0,5, 25 and 125 mg/kg
Basis:

Control animals:

yes

Examinations

Maternal examinations:

BODY WEIGHT: Yes

FOOD CONSUMPTION : Yes

Ovaries and uterine content:

The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of implantations: Yes
- Number of absorption: Yes

Fetal examinations:

- External examinations: Yes
- Skeletal examinations: Yes

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Details on maternal toxic effects:
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 (though not statistically,,significant)increase in absorptions and consequently in post-implantation loss at 125 mg/kg.

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

25 other: mg/kg

Based on:

test mat.

Basis for effect level:

other: maternal toxicity

Remarks on result:

other: not specified

Maternal abnormalities

Abnormalities:

not specified

Localisation:

not specified

Description (incidence and severity):

not specified

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
*No statistically significant or toxicologically relevant adverse effects on any of the embryotoxicity parameters studied were observed in the 5 and 25 mg/kg dose groups.
*A statistically significant reduction was recorded in the average body weight gains and food consumption in both the 25 and 125 mg/kg groups.
No other clinical signs of test article-related toxicity were observed for the parameters evaluated in any of the dose groups during the course of the treatment.
*There was also a significant delay in ossification of a few skeletal elements of the fetuses in this high-dose group when compared to controls.

Effect levels (fetuses)

Dose descriptor:

LOAEL

Effect level:

125 other: mg/kg bw

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: teratogenicity

Remarks on result:

other: not specified

Fetal abnormalities

Abnormalities:

not specified

Localisation:

other: not specified

Description (incidence and severity):

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Treatment related:

not specified

Applicant's summary and conclusion

Conclusions:

NOAEL for maternal toxicity study was considered to be 25 mg/kg whereas LOAEL for teratogenicity study 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 (CASRN 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 to assess its potential to promote embryotoxicity, fetotoxicity and/or teratogenicity.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.No statistically significant or toxicologically relevant adverse effects on any of the embryotoxicity parameters studied were observed in the 5 and 25 mg/kg dose groups.A statistically significant reduction was recorded in the average body weight gains and food consumption in both the 25 and 125 mg/kg groups.No other clinical signs of test article-related toxicity were observed for the parameters evaluated in any of the dose groups during the course of the treatment.There was also a significant delay in ossification of a few skeletal elements of the fetuses in this high-dose group when compared to controls.Hence, NOAEL for maternal toxicity study was considered to be 25 mg/kg whereas LOAEL for teratogenicity study was considered to be 125 mg/kg in Charles River CrI:CD BR rats when 3,4-dichloroaniline was administered orally by gavage.