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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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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:
other: This study is assigned a reliability score of 2 because the original report was not available for review. However, the study was evaluated by IPCS prior to inclusion in their criteria document.
Justification for type of information:
Study is read-across from LAS. Please refer to section 13 for the read-across justification

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts.
Author:
European Commission
Year:
2000
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:
1978
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

Constituent 1
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
Molecular formula:
C16-19 H25-31 Na O3 S
IUPAC Name:
sodium 4-undecylbenzenesulfonate
Details on test material:
C10-13 LAS, sodium salt (CAS #68411-30-3)

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:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
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:
effects observed, treatment-related
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:
no effects observed
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
Dose descriptor:
NOAEL
Effect level:
125 other: mg/kg bw d
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Serum-biochemical differences
Dose descriptor:
LOAEL
Effect level:
250 other: mg/kg bw d
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Serum-biochemical differences

Target system / organ toxicity

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.