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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study; well-performed and well-documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Product No. Code: 01-FMLY 022
pH value: approx.9 (10g/L)
Content: 80% Pentapropylensuccinic anhydride, EA/Na/TEA 10% Olefin(C15-Spetapropylen), 10% Water

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Body weight of animals at start of experiment: 3,6 kg
Age of animals: 3-5 month

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single application
Observation period (in vivo):
Up to 14 days
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
within 7days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
1
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
2.33
Max. score:
3
Reversibility:
not reversible
Remarks:
within 7 days
Other effects:
Vascularisation was found on day 7.

Applicant's summary and conclusion

Interpretation of results:
other: R41: risk of serious damage to eyes
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The eye irritation potential of Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was investigated according to the OECD Guideline 405. Based on the study result Pentapropylensuccinic anhydride, EA/Na/TEA should be classified as R41: risk of serious damage to eyes.
Executive summary:

The eye irritation potential of Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was investigated according to the OECD Guideline 405. 0.1 ml of test substance was given into the eye of a rabbit. Severe effects up to reading score of 3 were found for cornea, conjuntivae and chemosis and no indication of recovery was found. On day 7 clear vascularisation was identified. Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts should be classified as R41: risk of serious damage to eyes.