Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting 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.

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:

Subacute toxicity of linear alkylbenzene sulfonate. cited in IPCS. 1996. Environmental Health Criteria 169: Linear Alkylbenzene Sulfonates and Related Compounds. World Health Organization, Geneva, Switzerland.

Author:

Yoneyama, M, Mabuchi, Y., Ikawa, M., Kobayashi, H., and Ichikawa, H.

Year:

1976

Bibliographic source:

Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 27:105-112 (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 in drinking water daily for 9 months.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts

EC Number:

274-070-8

EC Name:

Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts

Cas Number:

69669-44-9

IUPAC Name:

sodium 4-dodecylbenzenesulfonate

Details on test material:

C10-14 LAS, sodium salt (CAS #69669-44-9); average alkyl chain length = C11.7

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

not specified

Details on oral exposure:

LAS was provided daily in drinking water.

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

nine months

Frequency of treatment:

daily in drinking water

Doses / concentrations

Remarks:

Doses / Concentrations:
85, 145, 430 mg/kg bw d. (0.07, 0.2, 0.6%)
Basis:
nominal in water

No. of animals per sex per dose:

Information as cited in IPCS document. 8-9 animals of each sex 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:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Details on results:

Body weight gain was suppressed in the male 0.6% group. Hematological examination revealed no significant change in any of the experimental groups, but a dose-related decrease in cholesterol level was seen in males. Significant decreases in the activities of glutamate-oxalate transaminase and lactate dehydrogenase were seen in males at 0.2% and a dose-related increase in the activity of gluatamate-oxalate transaminase in females. A significant decrease in renal Na,K-ATPase was seen in the group given 0.2%. No organ weight changes were observed. The intake of LAS was 50 mg/kg bw/day in the male 0.07% group and 120 mg/kg bw/day in the female group. The values for the 0.2% group were 120 and 170 mg/kg bw/day for males and females, respectively.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

85 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: activities of glutamate-oxalate transaminase and lactate dehydrogenase and renal Na,K-ATPase

2

Dose descriptor:

LOAEL

Effect level:

145 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: Significant decreases in the activities of glutamate-oxalate transaminase and lactate dehydrogenase in males. A significant decrease in renal Na,K-ATPase in males and females.

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

NOAEL = 85 mg/kg bw/day; LOAEL = 145 mg/kg bw/day

Executive summary:

Male and female rats were exposed to Na-LAS in drinking water daily for 9 months. Body weight was suppressed in the highest dose group only. Significant decreases in transaminase activity and renal Na,K-ATPase was seen in the 0.2% group. The resultant LOAEL and NOAEL values were 145 and 85 mg/kg bw/day, respectively. The NOAEL represents the highest NOAEL below the lowest LOAEL.