Registration Dossier

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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.

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:
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

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

open allclose all
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
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.