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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate national standard method but full details are not available.

Data source

Reference
Reference Type:
publication
Title:
Safety evaluation of cosmetic raw materials.
Author:
Guillot J P et al
Year:
1977
Bibliographic source:
J. Cos. Chem. 28:377-393

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test method used was a modification of the French offical method for  testing cosmetics and Toiletries, 1971 & 1973.  Each sample was tested undiluted and as a 10% aqueous dispersion using an emulsifier and preservative. Four samples of Oleyl alcohol from different manufacturers were tested.  The composition of the samples was determined by GLC. Of the 4 samples tested one was less pure than the others. 
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cas# 143-28-3 Oleyl alcohol

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS

- Housing: in individual cages (600x540x315 mm)

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: applied undiluted as a 10% aqueous dispersion
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL

- Concentration (if solution): Each sample was tested undiluted and as a 10% aqueous dispersion using an  emulsifier and preservative. (Product 10 -15%, polyoxyethylene sorbitan stearate 3%, Preservative 0.2%, Water 100%)


Duration of treatment / exposure:
A single instillation.
Observation period:
1h, 24h, 48h
Number of animals:
3
Details on study design:
TEST SITE

- Type of wrap if used: Occlusive patches were used which were fixed using absorbent gauze held in place by adhesive tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): Not washed

SCORING SYSTEM: Non irritant; less than 0.5, slightly irritant 0.5 to 2.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Score:
1.71
Remarks on result:
other: Undiluted
Irritation parameter:
primary dermal irritation index (PDII)
Score:
1.58
Remarks on result:
other: Undiluted
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0.17
Remarks on result:
other: 10% aqueous dilution
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0.33
Remarks on result:
other: 10% aqueous dilution
Irritation parameter:
primary dermal irritation index (PDII)
Score:
1.67
Remarks on result:
other: Undiluted
Irritation parameter:
primary dermal irritation index (PDII)
Score:
1.75
Remarks on result:
other: Undiluted
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0.04
Remarks on result:
other: 10% aqueous dilution
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0.25
Remarks on result:
other: 10% aqueous dilution
Irritation parameter:
primary dermal irritation index (PDII)
Score:
1.5
Remarks on result:
other: Undiluted
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0.29
Remarks on result:
other: 10% aqueous dilution
Irritation parameter:
primary dermal irritation index (PDII)
Score:
1.33
Remarks on result:
other: Undiluted
Irritation parameter:
primary dermal irritation index (PDII)
Score:
0.42
Remarks on result:
other: 10% aqueous dilution
Irritant / corrosive response data:
The maximum index of 1.75 was found with Oleyl alcohol when tested undiluted. The average score of 0.28 was calculated for the diluted test substance.
Other effects:
When applied undiluted, exposure to the test substance resulted in important thickening and drying of the skins, eschars and fissures. When applied as a 10% solution the test substance was relatively well tolerated, with slight epidermal exfoliation.

Any other information on results incl. tables

The undiluted samples produced thickening and drying and cracking of the  skin with eschars. Histological examination typically revealed  

hyperacanthosis and a flattened stratum corneum. 

The 10% aqeuous dilutions were relatively well tolerated. Slight  epidermal exfoliation was observed with 3 samples. Histological 

examination showed showed some vascular congestion of the dermis without  inflammatory infiltration.

None of the test samples revealed evidence of hypersensitivity on challenge.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Journal Officiel de la republique Francaise.
Conclusions:
The test substance was found to be slightly irritating, but not requiring classification, in a reliable study conducted according to generally accepted scientific principles.