Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study. Only basic data is shown on the ECHA webpage.

Data source

Reference
Reference Type:
other: ECHA disseminated dossier
Title:
No information
Report Date:
2014

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

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Dose descriptor:
NOAEL
Effect level:
ca. 175 mg/kg bw/day
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOAEL
Effect level:
ca. 175 mg/kg bw/day
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

---Maternal toxicity:
450 mg-group:
4/25 died,
significant reduction in periodic maternal body weight and
weight gain during dosing,
reduction of food consumption,
clinical signs: at 450 mg/kg bw
hypoactivity, ataxia, tremor, twitches, prone positioning,
audible respiration, perioral wetness,

for all groups: gestational parameters uneffected, no early
delivery, no abortion;

---Evaluation of offspring:
450 mg/kg bw: slight fetotoxicity:
one visceral variation: dileted lateral ventricles of the
brain with no tissue compression;
NOEL (maternal): 175.0 mg/kg bw/day
NOEL (developmental): 175.0 mg/kg bw/day

Applicant's summary and conclusion