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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 is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Final report of the safety assessment of test chemical
Author:
Cosmetic Ingredients Review (CIR)
Year:
2005
Bibliographic source:
International Journal of Toxicology; 2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Low volume eye test
Principles of method if other than guideline:
Low volume eye test of test chemical were performed in New Zealand White Rabbits to determine the degree of eye irritancy caused by the chemical.
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): Niacinamide
- Molecular formula: C6H6N2O
- Molecular weight: 122.1264 g/mol
- Substance type: Organic
- Physical state:Solid (powder)
-Smiles: c1cc(cnc1)C(=O)N
- InChI: 1S/C6H6N2O/c7-6(9)5-2-1-3-8-4-5/h1-4H,(H2,7,9)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
water
Controls:
not specified
Amount / concentration applied:
15% and 25%
Duration of treatment / exposure:
10 days
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
No data available
Details on study design:
No data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
10 d
Score:
0.67
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No eye irritating effects were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test material was considered to be non-irritating to the eye of New Zealand White Rabbits in Low volume eye test.
Executive summary:

Low volume eye test of test chemical was performed in New Zealand White Rabbits to determine the degree of eye irritancy caused by the chemical.

 

During the test, 16% and 25% of test substance dissolved in water was placed into the eye of each rabbits.

 

The maximum average score (MAS) observed was 0.67 and the effects observed were cleared within 10 days.

 

Since the chemical did not produce any acute ocular hazards, the chemical was considered to be non-irritating to the eye of New Zealand White Rabbits.