Registration Dossier
Registration Dossier
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EC number: 941-154-7 | CAS number: -
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts.
- Author:
- European Commission
- Year:
- 2 000
- Bibliographic source:
- Year 2000 CD-ROM edition.
- Reference Type:
- publication
- Title:
- cited in IPCS. 1996. Environmental Health Criteria 169: Linear Alkylbenzene Sulfonates and Related Compounds. World Health Organization, Geneva, Switzerland.
- Author:
- Ito, R., Kawamura, H., Chang, H.S., Kudo, K., Kajiwara, S., Toida, S., Seki, Y., Hashimoto, M. and Fukushima, A.
- Year:
- 1 978
- Bibliographic source:
- J. Med. Soc. Toho, Japan, 25:850-875 (in Japanese)
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male and female rats were exposed to Na-LAS via gavage daily for 28 days.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
- EC Number:
- 270-115-0
- EC Name:
- Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
- Cas Number:
- 68411-30-3
- IUPAC Name:
- sodium 4-undecylbenzenesulfonate
- Details on test material:
- C10-13 LAS, sodium salt (CAS #68411-30-3)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- one month
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
125, 250, 500 mg/kg bw d.
Basis:
no data
- No. of animals per sex per dose:
- Information as cited in IPCS document. 12 animals per dose group.
- Control animals:
- yes, concurrent no treatment
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Diarrhea was observed in the 500 mg/kg group and soft stools were observed in the other 2 groups. Body weight gain was suppressed in all the male groups and in the female 500 mg/kg group. Haematological examinations revealed no abnormalities. Serum-biochemical examinations revealed several differences among the mid and high dose group compared to the control group. The weight of the spleen and the heart significantly decreased in the male high dose group. In the female high dose group, the weight of the liver increased while the weight of the heart and thymus decreased. Histological findings of the liver revealed no abnormalities.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 125 other: mg/kg bw d
- Sex:
- male/female
- Basis for effect level:
- other: Serum-biochemical differences
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 250 other: mg/kg bw d
- Sex:
- male/female
- Basis for effect level:
- other: Serum-biochemical differences
Target system / organ toxicity
- Key result
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL = 125 mg/kg bw/day; LOAEL = 250 mg/kg bw/day
- Executive summary:
Male and female rats were exposed to Na-LAS 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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