Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: dermal

Currently viewing:

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 for cross-reference:
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
Guideline:
OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
Deviations:
yes
Remarks:
secondary literature
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
EC Number:
931-534-0
Cas Number:
68439-57-6
Molecular formula:
C(4+2n)H(9+4n)SO4Na C(4+2n)H(7+4n)SO4Na n = 5-6
IUPAC Name:
Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
Constituent 2
Reference substance name:
Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
IUPAC Name:
Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts
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 or test system 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