Registration Dossier

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Administrative data

Description of key information

The registration substance is not irritating to skin and eye. The assessment is based on the in-vivo studies in rabbits.

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:
1991-03-05 to 1991-03-12
Reliability:
2 (reliable with restrictions)
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)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
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:
4 hours
Observation period:
7 days
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
1.1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The skin irritation potential ot the registration substance was investigated according to the OECD Guideline 404. The registration substance is not skin irritating.
Executive summary:

The skin irritation potential ot the registration substance was investigated according to the OECD Guideline 404. Erythema of up to scoring of 2 was found within three days after treatment, which was reversible within 7 days.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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:
2 (reliable with restrictions)
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)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml to the conjunctival sac
Duration of treatment / exposure:
single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48 and 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.4
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24,48 and 72 hours
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within: 7 days
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
(Pentapropenylsuccinimido)-caproic acid is not irritating to eyes according to the study result of OECD 405.
Executive summary:

(Pentapropenylsucciminido)-caproic acid was investigated for its eye irritation potential according to the Gudiedline OECD 405. It induced transient irritating effects that were reversible within 7 days. No classificaiton is warranted.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

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

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

Justification for classification or non-classification

The registration substance is not irritating to skin and eye. The assessment is based on the in-vivo studies in rabbits. No classification is warranted.