Ammonium dodecylbenzenesulphonate

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

The original report was not available for review. However, the study was evaluated by IPCS prior to inclusion in their criteria document.
sodium salt used for testing

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.