Registration Dossier
Registration Dossier
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EC number: 202-453-1 | CAS number: 95-80-7
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Screening model for developmental effects. Not equivalent to OECD guideline. Provides useful information for assessment.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Based on Chernoff Kavlock reproductive toxicity screening test. 2,4-TDA was investigated in a screening assay covering a several chemicals. Only a single dose, the MTD.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-methyl-m-phenylenediamine
- EC Number:
- 202-453-1
- EC Name:
- 4-methyl-m-phenylenediamine
- Cas Number:
- 95-80-7
- Molecular formula:
- C7H10N2
- IUPAC Name:
- 4-methylbenzene-1,3-diamine
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- 2,4-TDA was investigated in a screening assay covering a total of 60 chemicals at one dose level only, where a group of 50 CD-1 albino mice was treated orally by gavage with 150 mg 2,4-TDA/kg bw/d in corn oil in a volume of 10 ml/kg bw on gestational days 6 to 13.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- 150 mg/kg bw/d in corn oil in a volume of 10 ml/kg bw, oral gavage, at 10 ml/kg, for 8 consecutive days.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not applicable.
- Details on mating procedure:
- Not available.
- Duration of treatment / exposure:
- 8 days
- Frequency of treatment:
- Daily from gestational days 6-13.
- Duration of test:
- From gestational days 6 to day 3 post partum
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 150 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data.
Examinations
- Maternal examinations:
- No data.
- Ovaries and uterine content:
- No data.
- Fetal examinations:
- No data.
- Statistics:
- No data.
- Indices:
- No data.
- Historical control data:
- No data.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Signs of clear-cut maternal toxicity was noted as 17 out of the 50 dams died and a significantly reduced mean body weight change was observed.
In the surviving dams significant reduction of number of live litters (5 out of 20) as well as the number of live born per litter was observed. In the remaining offspring birth weight, weight gain, and viability through the first three postpartum days were not significantly different from that of the control group.
Effect levels (maternal animals)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No effects.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- 2,4-TDA had been investigated in a screening assay covering several chemicals at one dose level only, where a group of 50 mice was treated orally
by gavage with 150 mg 2,4-TDA/kg bw/d in corn oil in a volume of 10 ml/kg bw on gestational days 6 to 13. This dose was equivalent to the LD10
predicted from a preceding dose-finding study in non-pregnant animals and revealed signs of clear-cut maternal toxicity as 17 out of the 50 dams
died and a significantly reduced mean body weight change was noted. In the surviving dams treatment with 2,4-TDA significantly reduced the number of live litters (5 out of 20) as well as the number of live born per litter. In the remaining offspring birth weight, weight gain, and viability through
the first three postpartum days were not significantly different from that of the control group.
Reproductive effects were seen in the presence of marked maternal toxicity.
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