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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 journals

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
OPINION ON Picramic acid and sodium picramate COLIPA n° B28
Author:
Scientific Committee on Consumer Safety,
Year:
2012
Bibliographic source:
Scientific Committee on Consumer Safety, (SCCS) 18 September 2012
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Sodium Picramate
Author:
Cosmetic Ingredient Review Panel
Year:
1992
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY; Volume 11, Number 4,1992
Reference Type:
publication
Title:
Amended Safety Assessment of Sodium Picramate and Picramic Acid
Author:
Lillian C. Becker, Wilma F. Bergfeld, Donald V. Belsito, Curtis D. Klaassen, JamesG.Marks Jr, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, and F. Alan Andersen
Year:
2009
Bibliographic source:
International Journal of Toxicology; 28(Suppl 3); 205S-216S, 2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the eye irritation potential of the test chemical in albino rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
other: 2.5% aqueous test chemical (buffered to pH 7)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1ml of 2.5% aqueous test chemical (buffered to pH 7)
Duration of treatment / exposure:
the lids were held together for 1 second
Observation period (in vivo):
24, 48, and 72 hours
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: At 10 seconds post-instillation, the eyes were rinsed with 20 mL of distilled water

Observation period:Reactions were scored at 24, 48, and 72 hours post-instillation.

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: no data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Mild conjunctival inflammation was observed in each animal.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Mild conjunctival inflammation was observed in each animal. It can be considered that 2.5% aqueous test chemical solution (buffered to pH 7) was not an ocular irritant
Executive summary:

The eye irritation potential of the test chemical was assessed in albino rabbits.

0.1 ml of 2.5% aqueous test chemical (buffered to pH 7) was instilled into the eyes of albino rabbits (N = 3) and the lids were held together for 1 second. At 10 seconds post-instillation, the eyes were rinsed with 20 mL of distilled water. Untreated eyes served as controls. Reactions were scored at 24, 48, and 72 hours post-instillation.

Mild conjunctival inflammation was observed in each animal. It can be considered that 2.5% aqueous test chemical solution (buffered to pH 7) was not an ocular irritant