Registration Dossier
Registration Dossier
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EC number: 939-185-6 | CAS number: -
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental 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 IU section 13.
Data source
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- 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
Constituent 1
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity - decreased body weight gain
- Dose descriptor:
- LOAEL
- Effect level:
- 500 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity - incomplete ossification
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: teratogenicity
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 50 mg/kg bw/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There is no developmental toxicity study available with the target substance. Data generated with the category substances LAB and LABS Na are considered pivotal to this endpoint. LAB was not classified as a teratogen; therefore the target substance is not classified as teratogen.
- Executive summary:
Groups of 24 mated female rats were exposed to concentrations of 0, 125, 500, and 2000 mg/kg bw/day of test substance by oral ganave during days 6 -15 of gestation. On day 20 of gestation, the animals were sacrificed and the uterine contents examined. Pups were removed by caesarean section and soft tissue and skeletal examinations performed. The LOAEL for maternal toxicity was 500 mg/kg bw/day based on reduced body weight gain. The NOAEL for amternal toxicity was 125 mg/kg bw/day. The LOAEL for embryotoxicity was also 500 mg/kg bw/day based on increased incidence of incomplete ossification. The NOAEL for embryotoxicity was also 125 mg/kg bw/day. Since no embryotoxicity was seen at doses that were not toxic to the maternal animals, the test substance is not classified as teratogenic.
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