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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a GLP guideline study. Study was conducted in accordance to GLP and OECD guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Pentaerythritol, propoxylated, (Molecular weight Mn = 420 g/mole)
Lot No. 0024
Storage: Room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye was used as control
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
Not Rinsed


SCORING SYSTEM: Kay and Calandra classification system


TOOL USED TO ASSESS SCORE: Standard Opthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study. Minimal  conjunctival irritation was noted in all treated eyes one hour after  treatment. All treated eyes appeared normal at the 24-hour observation.  According to EU classification criteria, the test substance is not an eye  irritant.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 4.0 and was classified as minimal irritant (Class 3 on A 1 to 8 scale) to the rabbit eye according to Kay and Calandra classification system. The effects observed do not warrant classification in the EU.