Registration Dossier
Registration Dossier
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EC number: 903-982-7 | CAS number: -
Endpoint summary
Administrative data
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
- 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
- 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
- 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.
Referenceopen allclose all
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 test substance, 5% in petrolatum, produced no irritation after 48-hr closed-patch test in 5 human subjects.
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
