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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study appears well conducted by knowledgable personnel, but reported only as an abstract.

Data source

Reference
Reference Type:
publication
Title:
A rat teratology study with tetrthal (tetrachlorphthalic anhydride)
Author:
Nair R et al.
Year:
1984
Bibliographic source:
Federation Proceedings. Fed AM Soc Exp Biol. 43(3):365.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
GD 6 - GD 19
Frequency of treatment:
Once daily
Duration of test:
Sacrificed on GD 20
No. of animals per sex per dose:
24 mated females/dose group
Control animals:
yes, concurrent vehicle

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Details on maternal toxic effects:
No mortality during test. Only clinical signs were lethargy in mid and high dose grops. Pregnancy rates, mean numbers of corpora lutea, implantations, resportions and live fetuses were comparable between control and treated groups.

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: See Remarks on results
Remarks on result:
other:
Remarks:
No mortality during test. Only clinical signs were lethargy in mid and high dose grops. Pregnancy rates, mean numbers of corpora lutea, implantations, resportions and live fetuses were comparable between control and treated groups.

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes. Remark: 2000 mg/kg

Effect levels (fetuses)

Key result
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
not specified
Basis for effect level:
other: fetotoxicity
Remarks on result:
other:
Remarks:
At 2000 mg/kg bw: decrease in fetal body weights, increase in incidence of fetuses with ossification variations an a slight, but nto statistically signfificant, increase in veretebral or rib defects. No maternal toxicity, embryotoxicity, fetotoxicity or teratogenic effects were observed at or below 1000 mg/kg.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
TCPA at doses of <= 1000 mg/kg bw adminstered daily on GD 6 - GD 19 to rats by gavage in corn oil induced no maternal toxicity, embryotoxicity, fetotoxicity or teratogenic effects.
Executive summary:

TCPA at doses of <= 1000 mg/kg bw adminstered daily on GD 6 - GD 19 to rats by gavage in corn oil induced no maternal toxicity, embryotoxicity, fetotoxicity or teratogenic effects.