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Toxicological information

Repeated dose toxicity: oral

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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

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

Effect levels

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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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