Registration Dossier
Registration Dossier
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EC number: 939-185-6 | CAS number: -
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- The justification document for the read across category approach is included in IU section 13.
Data source
Materials and methods
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
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No short term repeated dose oral toxicity study with the target substance is available. Data generated with the category substance LABS Na was considered pivotal to this endpoint. The target substance is considered to have a NOAEL of 125 mg/kg bw/day and LOAEL of 250 mg/kg bw/day.
- Executive summary:
Male and female rats were exposed to LABS Na via gavage daily for 28 days. Body weight gain was suppressed, some serum biochemical measures were different from the controls, and some organ weights were either decreased (spleen, heart, thymus) or increased (liver) in either the male or female high dose groups. No mortalities or histopathological abnormalities were observed. The resultant LOAEL and NOAEL values were 250 and 125 mg/kg bw/day, respectively.
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