Registration Dossier

Administrative data

Description of key information

Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was irritating to rabbit skin and caused serious damage to rabbit eye. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-07-02 to 1991-07-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study; well-performed and well documented
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Body weight at start of experiment: 2,8 - 3,2 kg
Age: 3 - 5 month
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4h
Observation period:
up to 14 days
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The skin irritation potential of pentapropylensuccinic anhydride, EA/Na/TEA was investigated according to the OECD Guideline 404. Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts should be classified as R38.
Executive summary:

The skin irritation potential of Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was investigated according to the OECD Guideline 404. Erythema in three rabbits up to the score of 3 and oedema in one rabbit up to the score of 1 was obtained for readings at 24, 48 and 72 hours. All effects were reversible within 7 days. Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts should be classified as R38.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

The skin irritation potential of Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was investigated according to the OECD Guideline 404. Erythema in three rabbits up to the score of 3 and oedema in one rabbit up to the score of 1 was obtained for readings at 24, 48 and 72 hours. All effects were reversible within 7 days.

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.


Justification for selection of skin irritation / corrosion endpoint:
well-performed and well-documented study

Justification for selection of eye irritation endpoint:
well-performed and well-documented study

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was tested for its skin and eye irritation/corrosion potential in rabbits. Based on the obtained result Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts should be classified as R38 and R41.