Registration Dossier

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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:
Studies on the toxicity of synthetic detergents. (II) Subacute toxicity. Cited in IPCS. 1996. Environmental Health Criteria 169: Linear Alkylbenzene Sulfonates and Related Compounds. World Health Organization, Geneva, Switzerland.
Author:
Yoneyama M., Fujii T., Ikawa M., Shiba H., Sakamoto Y., Yano N., Kobayashi H., Ichikawa H. and Hiraga K.
Year:
1972
Bibliographic source:
Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 24:409-440 (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 the diet daily for 6 months.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
C10-14 LAS, sodium salt (CAS #69669-44-9) C 10 10.6%, C 11 34.1%, C 12 27.7%, C 13 19.0% C 14 8.7%; average alkyl chain length = C11.8; mean molecular weight: 345.8

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
six months
Frequency of treatment:
daily in feed
Doses / concentrations
Remarks:
Doses / Concentrations:
40, 115, 340, 1030 mg/kg bw d. (0.07, 0.2, 0.6, 1.8%)
Basis:
nominal in diet
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:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not specified
Details on results:
The 1.8% group showed diarrhea, markedly suppressed growth, increased weight of the cecum, and remarkable degeneration of the renal tubes. the 0.6% group showed slightly suppressed growth, increased weight of the cecum, increased activity of serum alkaline phosphatase (ALP), a decrease in serum protein and degeneration of the renal tubes. The 0.2% group showed increased weight of the cecum and slight degeneration of the renal tubes. The 0.07% group showed no adverse effects related to the administration of LAS. The intake of LAS in the 0.07% group was about 40 mg/kg bw/d.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
40 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: increased weight of the cecum and slight degeneration of the renal tubes
Dose descriptor:
LOAEL
Effect level:
115 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: increased weight of the cecum and slight degeneration of the renal tubes

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL = 40 mg/kg bw/day; LOAEL = 115 mg/kg bw/day
Executive summary:

Male and female rats were exposed to Na-LAS in the diet daily for 6 months. Diarrhea, suppressed growth, increased cecal weight, and degeneration of renal tubes characterized the highest dose group. Similar but less severe signs were seen in other doses with the exception of the lowest dose of 0.07%, which showed no adverse effects related to exposure to LAS. The resultant LOAEL and NOAEL values were 115 and 40 mg/kg bw/day, respectively. This represents the lowest LOAEL of any study.