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Description of key information

Supporting study: The substance was moderately irritating to the skin of rabbits.

Supporting study: The substance was not irritating to skin at a concentration of 5% in petrolatum in humans.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: A scientific review (peer reviewed). No data on GLP. The described method is not equivalent to OECD guideline.
Principles of method if other than guideline:
-Principle of test: Irritation was evaluated as a part of an acute dermal LD50 study conducted on 10 rabbits. Irritation was assess after a single 24 h occluded dermal application of neat (5000 mg/kg) fenchyl acetate.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
24 h
Number of animals:
10
Irritation parameter:
overall irritation score
Basis:
mean
Remarks on result:
probability of moderate irritation

A single 24 h occluded dermal application of neat (5 g/kg) test material produced moderate erythema (10/10) and slight (1/10) to moderate (7/10) edema, observed after patch removal.

Interpretation of results:
study cannot be used for classification
Conclusions:
The substance was moderately irritating to the skin of rabbits.
Executive summary:

Irritation was evaluated as a part of an acute dermal LD50 study conducted on 10 rabbits. A single 24 h occluded dermal application of neat (5 g/kg) test material produced moderate erythema (10/10) and slight (1/10) to moderate (7/10) edema, observed after patch removal. The substance was moderately irritating to the skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: A scientific review (peer reviewed). No data on GLP. The described method is not equivalent to OECD guideline.
Principles of method if other than guideline:
-Principle of test: In a pre-test for a maximization study, a 48 h occluded patch test was conducted on 5 healthy volunteers.
GLP compliance:
not specified
Species:
human
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: petrolatum
Controls:
not specified
Amount / concentration applied:
5 % in petrolatum
Duration of treatment / exposure:
48 h
Number of animals:
5 volunteers
Irritation parameter:
overall irritation score
Basis:
mean
Remarks on result:
no indication of irritation

The test substance, 5% in petrolatum, produced no irritation after 48-hr closed-patch test in 5 human subjects.

Interpretation of results:
study cannot be used for classification
Conclusions:
The substance was not irritating to skin at a concentration of 5% in petrolatum in humans.
Executive summary:

In a pre-test for a maximization study, a 48 h occluded patch test was conducted on 5 healthy volunteers. No irritation was produced by fenchyl acetate at 5% in petrolatum.

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Supporting study: Irritation was evaluated as a part of an acute dermal LD50 study conducted on 10 rabbits. A single 24 h occluded dermal application of neat (5 g/kg) test material produced moderate erythema (10/10) and slight (1/10) to moderate (7/10) edema, observed after patch removal. The substance was moderately irritating to the skin.

Supporting study: In a pre-test for a maximization study, a 48 h occluded patch test was conducted on 5 healthy volunteers. No irritation was produced by fenchyl acetate at 5% in petrolatum.

Justification for classification or non-classification