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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From February 9, 1998 to January 15, 1999.
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
Deviations:
yes
Remarks:
not impairing the study results.
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 %, low viscosity, white powder, Sigma Chemical Company.
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
From gestational Day 7 to through Day 28.
Frequency of treatment:
Once per day.
Duration of test:
From gestational Day 7 until Day 29.
Doses / concentrations
Remarks:
Doses / Concentrations:
100, 400, and 800 mg/kg bw
Basis:
actual ingested
constant volume of 10 ml/kg/day in 0.5 % of CMC.
No. of animals per sex per dose:
25 females/group
Control animals:
yes, concurrent vehicle

Examinations

Statistics:
Differences between groups were assessed using:
- Group pair-wise Comparison: Levene’s test, Dunnett’s test, Welch’s test with a Bonferroni correction (homogeneity).
- Arcsin-Square-Root Transformation.
- Chi-square test (homogeneity).
- Kruskal-Wallis test, Mann-Whitney U-test (malformations).
- Parson Chi-Square, Fishers exact test (malformations and developmental variations).
- Descriptive statistics (means, SD).

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOEL
Effect level:
100 mg/kg bw (total dose)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Dose descriptor:
NOEL
Effect level:
100 mg/kg bw/day
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
400 mg/kg bw (total dose)
Based on:
test mat.
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion