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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:
key study
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 journal.

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of test substance
Author:
Cosmetic Ingredient Review Panel
Year:
1984
Bibliographic source:
International Journal of Toxicology, 1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
An eye irritation study was condcuted to determine the adverse effects caused by the chemical six albino New Zealand rabbits.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): tert-butyl-4-methoxyphenol
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
albino

Test system

Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
48 hours
Observation period (in vivo):
24 and 48 hours
Details on study design:
Not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24
Score:
2
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: minimal or mild eye irritation in rabbits.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48
Score:
0
Max. score:
110
Reversibility:
not specified
Irritant / corrosive response data:
Minimal irritation was observed in treated rabbits.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test chemical was considered to be mildly irritating to the skin of treated albino rabbits.
Executive summary:

The eye-irritating ability of a face powder containing 0.2 percent test chemical was studied in six albino New Zealand rabbits. The test material was instilled into one eye of each animal in a single 0.1 ml dose; the untreated eye of each rabbit served as control.

Average eye irritation scores 24 and 48 hours following exposure to the face powder were 2 and 0, respectively (the maximum possible score per observation was 110).

The author concluded the test chemical as minimal irritating to the eye of treated albino rabbits.