Registration Dossier

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: original data not available

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1972

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity not given

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
day 6-15 of gestation
Frequency of treatment:
once daily
Doses / concentrations
Remarks:
Doses / Concentrations:
1.75; 8; 38 or 175 mg/kg/d
Basis:

Control animals:
yes, concurrent no treatment

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
>= 175 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
>= 175 mg/kg bw/day
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

No effect on nidation or on maternal or fetal survival; the number of abnormalities of soft and skeletal tissues did not differ from number in controls; maternal toxicity was not reported at any dose applied.

Applicant's summary and conclusion