Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with diethanolamine

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

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.

Data source

Reference

Reference 1

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 2

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

Test material information

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:

C17H27NaO3S

IUPAC Name:

sodium 4-undecylbenzenesulfonate

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

Doses / concentrations 1

Dose / conc.:

125 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

250 mg/kg bw/day (nominal)

Doses / concentrations 3

Dose / conc.:

500 mg/kg bw/day (nominal)

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

1

Key result

Dose descriptor:

NOAEL

Effect level:

125 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: Serum-biochemical differences

2

Key result

Dose descriptor:

LOAEL

Effect level:

250 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: Serum-biochemical differences

Target system / organ toxicity

Key result

Critical effects observed:

no

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.