Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data, List III
Author:
Smyth H.F., Carpetnter C.P. and Weil C. S.
Year:
1949
Bibliographic source:
J. Ind. Hyg. Toxicol., 31, 60-62

Materials and methods

Principles of method if other than guideline:
Eye injury in rabbits is recorded in a 10-grade ordinal series and is based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
other: undiluted sample or solutions in water or propylene glycol
Amount / concentration applied:
several amounts starting at 500μL (based on Carpenter et al., 1946, Chemical Burns of the Rabbit Cornea. Am.J.Opthal. 29:1363)
Duration of treatment / exposure:
no data
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
no data (usually 5)
Details on study design:
SCORING SYSTEM: Grade 1 indicates at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn f rom 0.005 ml, and Grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water or propyene glycol.

Results and discussion

In vivo

Results
Remarks on result:
other: The primary eye irritation was graded as 2.
Irritant / corrosive response data:
The primary eye irritation was graded as 2. This corresponds to 0.5 ml of undiluted test substance resulting in a score between 1 and 5.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Based on the Harmonised classificatation Annesx VI of Regulation (EC) No 1272/2008 (CLP Regulation) the substance is classified as irritating to eyes cat. 2 (H319).