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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary literature
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
Environmental and human safety of major surfactants. Volume 1. Anionic surfactants. Part 4. Alpha olefin sulfonates
Author:
Little, A.D.
Year:
1993
Bibliographic source:
National Technical Service (NTIS) report No. PB94-102423

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
Deviations:
yes
Remarks:
secondary literature
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Alpha olefin sulfonate (AOS)

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Details on exposure:
TEST MATERIAL
- Concentration (if solution): 5% solution of 34% active, corresponding to 1.7%



Duration of treatment / exposure:
91 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
2 mL/kg bw/d (corresponding to 35.7 mg/kg bw/d)
Basis:
no data
No. of animals per sex per dose:
6

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Dermal irritation:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
no effects observed
Details on results:
At necroscopy, hematology, organ weights and organ to body weight data were all normal. Skin irritation was rated to mild to moderate as there was non-suppurative dermatitis, parakeratosis and hyperkeratosis observed. One of the animals had a firm, swollen salivary gland which upon microscopic examination exhibited inflammation and hyperplastic changes.

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 2 other: mL/kg bw/d
Based on:
test mat.
Sex:
not specified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion