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Toxicological information

Eye irritation

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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 taken from one or many reviews of high purity higher olefines (C17 - C22, linear and branched)
These oils, whether from mineral or vegetable source, are used in foods, pharmaceutical products and personal care products.
Primary sources are not cited, but references are made to earlier food and paharmaceutal reviews
Report authored by the German MAK Commission

Data source

Reference
Reference Type:
publication
Title:
White mineral oil, pharmaceutical [review]
Author:
A. Hartwig, MAK Commission
Year:
2017
Bibliographic source:
The MAK Collection for Occupational Health and Safety 2017, Vol 2, No 3

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Not specified in the review
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
White mineral oil (petroleum)
EC Number:
232-455-8
EC Name:
White mineral oil (petroleum)
Cas Number:
8042-47-5
Molecular formula:
C15 - C50
IUPAC Name:
White mineral oil
Test material form:
liquid
Specific details on test material used for the study:
Specified C15 - C15 aliphatic

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
According to guideline, 0.1 ml
Duration of treatment / exposure:
Not speified if washed
Observation period (in vivo):
At least 72 hours
Number of animals or in vitro replicates:
Not specified in the review

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Reversibility:
other: Not applicabnle
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No indication of further adverse effect in review.
No effect on the cornea reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Very low potential for irritation.