Registration Dossier

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:
other: acceptable publication which meets basic scientic principles; basic data on expermimental design are given.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VII
Author:
Smyth, HF; Carpenter, CP; Weil, CS; Pozzani UC; Striegel JA; Nycum, JS
Year:
1969
Bibliographic source:
Amer. Ind. Hyg. Assoc. J. 30 (1969), 470
Report Date:
1969
Reference Type:
publication
Title:
Chemical Burns of the Rabbit Cornea
Author:
Carpenter, CP; Smyth, HF
Year:
1946
Bibliographic source:
Am J Ophthalmol 29, 1363-1372
Report Date:
1946

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
pre-guideline study. primary eye irritation test. quantity of test substance applied and scoring system are different from OECD 405 or Draize
GLP compliance:
no
Remarks:
pre-GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
other: propylene glycol
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 ml
- Concentration (if solution): no data
Duration of treatment / exposure:
24h
Observation period (in vivo):
24h
Number of animals or in vitro replicates:
5
Details on study design:
comment: not rinsed

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
other: no data
Time point:
other: 24h
Score:
7
Max. score:
10
Remarks on result:
other: indicates severe burn with 0,5 ml of 15% solution

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
while the criteria used by Smyth et all cannot be directly translated into CLP criteria and the test system does not provide data on reversibility, the rating justifies a GHS classification of 2A (in the UN system)
Executive summary:

in an primary eye irritation test, the test substance was applied in seveal concentrations to the eye of 5 rabbits per dose level for 24h. Immediately after the application period the irritiation effects were scored on a scale of 1 -10. The test substance was rated as 7.