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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Squalane and Squalene
Author:
Cosmetic Ingredient Expert Review Panel
Year:
1990
Bibliographic source:
International Journal of Toxicology, Vol 1, Issue 2, pp. 37 - 56,January 1, 1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: modified official French method
Principles of method if other than guideline:
To assess the ocular irritation of Squalane in rabbits according to modified official French method
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6,10,15,19,23-hexamethyltetracosane
EC Number:
203-825-6
EC Name:
2,6,10,15,19,23-hexamethyltetracosane
Cas Number:
111-01-3
Molecular formula:
C30H62
IUPAC Name:
2,6,10,15,19,23-hexamethyltetracosane
Test material form:
liquid
Details on test material:
Name of the test chemical:2,6,10,15,19,23-hexamethyltetracosane, Squalane
Molecular Formula: C30H62
Molecular Weight: 422.80 g/mol
Substance Type: Organic
Physical State: Liquid
InChI: 1S/C30H62/c1-25(2)15-11-19-29(7)23-13-21-27(5)17-9-10-18-28(6)22-14-24-30(8)20-12-16-26(3)4/h25-30H,9-24H2,1-8H3
Specific details on test material used for the study:
Name of the test chemical:2,6,10,15,19,23-hexamethyltetracosane, Squalane
Molecular Formula: C30H62
Molecular Weight: 422.80 g/mol
Substance Type: Organic
Physical State: Liquid
InChI: 1S/C30H62/c1-25(2)15-11-19-29(7)23-13-21-27(5)17-9-10-18-28(6)22-14-24-30(8)20-12-16-26(3)4/h25-30H,9-24H2,1-8H3

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
undiluted test sample
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
one hour and at one, two, three, four, and seven days
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
6
Details on study design:
no data available

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
4.33
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Ocular irritation index at One hour = 4.33 and 7 days = 0.0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The Ocular Irritation Index (011) was 4.33 at one hour and 0.0 at 7 days
Based on the scores, 2,6,10,15,19,23-hexamethyltetracosane (Squalane) was not irritating to eyes
Executive summary:

A modified official French method was used to evaluate the eye irritation potential of undiluted Squalane in six albino rabbits. Eye readings were taken at one hour and at one, two, three, four, and seven days. The Ocular Irritation Index (011) was 4.33 at one hour and 0.0 thereafter. Based on the scores,2,6,10,15,19,23-hexamethyltetracosane (Squalane) was not irritating to eyes.