Registration Dossier

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:
other: Guideline study, published in peer-reviewed literature, very limited reporting, but acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
OECD Eye irritation tests on propylene glycol and Solketal
Author:
Jacobs GA
Year:
1988
Bibliographic source:
J. Am. Coll. Toxicol., 11, 739.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1,2-propanediol, propylene glycol, neat

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 μl
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
96 hours
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
0.1
Max. score:
2
Reversibility:
fully reversible within: 48 hr
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 96 hr
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
0
Max. score:
4

Applicant's summary and conclusion