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Administrative data

Endpoint:
two-generation reproductive toxicity
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
The justification for the read across category approach is included in the IU section 13.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, methyl-, C20-24 (even numbered) sec-alkyl derivs.
EC Number:
939-185-6
Molecular formula:
C8H11(CH2)nSO3 n=19-23
IUPAC Name:
Benzenesulfonic acid, methyl-, C20-24 (even numbered) sec-alkyl derivs.
Test material form:
liquid: viscous
Details on test material:
Appearance: viscous opaque suspension

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
reproductive performance
Remarks on result:
other: Maternal and paternal general toxicity was reduced weight gain in the high dose group. Reduced litter size in the high dose group.

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOEL
Generation:
F1
Effect level:
50 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
mortality
body weight and weight gain
Remarks on result:
other: Reduced survival and weight gain in high dose group. Sporadic occurrences at mid dose level

Results: F2 generation

Effect levels (F2)

Dose descriptor:
NOEL
Generation:
F2
Effect level:
50 mg/kg bw/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
mortality
body weight and weight gain
Remarks on result:
other: Reduced survival and weight gain in the high dose group. Sporadic occurrences at mid dose level

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
There is no reproductive toxicity study available with the target substance. Data generated with the category substances LABS Na and LAB was considered pivotal to this endpoint. No significant effects on reproduction were observed at the highest concentration LABS Na tested. During the study with LAB, animals were observed for clinical signs, mortality and body weight. Pups were examined for viability and body weight gain. Reproductive indices were also calculated. The NOAEL for parental toxicity was 50 mg/kg/day and the LOAEL was 500 mg/kg/day based on reduced weight gain and litter size in the high dose group. The NOAEL for offspring was 50 mg/kg/day based on reduced body weight gain and survival in the high and mid dose groups. The LOAEL for offspring was 50 mg/kg/day.