Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 617-391-4 | CAS number: 82832-73-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 MAY 2001 - 22 NOV 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This study was conducted according to Good Laboratory Practice (GLP) and followed the OECD Guideline for Testing of Chemicals No 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (1's,4'r)-4'-propyl-[1,1'-bi(cyclohexane)]-4-one
- EC Number:
- 617-391-4
- Cas Number:
- 82832-73-3
- Molecular formula:
- C15H26O
- IUPAC Name:
- (1's,4'r)-4'-propyl-[1,1'-bi(cyclohexane)]-4-one
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:KBL(NZW)BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: about 36 weeks
- Weight at study initiation: mean 4.42 kg (4.01 kg to 4.77 kg)
- Housing: All rabbits were housed in an air-conditioned room of about 50 m2. They were kept separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm2, a shelter with an integrated sitting board of about 1820 cm2; overall height: 60 cm) with plastic grids placed on mobile racks. The collection pans underneath the cages were cleaned at least three times a week. The cages were cleaned before the start of the study.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: > 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23
- Humidity (%): 40 - 69
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- The test material was mixed with some drops of Aqua pro injectione and ground in a mortar using a pestle.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 22 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: self-adhesive fabric (Fixomull® stretch, Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Any test material residues were wiped off
OBSERVATION TIME POINTS
- After 24, 48, 72 hours, and then daily up to experimental day 22
SCORING SYSTEM:
- Method of calculation: according to the DRAIZE-, OECD- and EEC recommendations
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Skin alterations
Erythema (scores 1 and 2) and edema (scores 1 and 2) were seen at the application sites from experimental day 1 up to experimental day 13.
Strong redness around the application sites was observed from experimental day 6 up to experimental day 8.
Leathery skin at the application sites and around were observed from experimental day 6 up to experimental day 12 followed by the formation of scales up to the end of the experimental part of the study . - Other effects:
- No signs of clinical toxicity were detected. All animals survived the observation period. Body weight development of the treated rabbits was inconspicuous.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- In this study the test item revealed a long acting irritating potential with mean erythema scores of 1 and mean edema scores of 1.33, 0.33 and 0.33 after 24, 48 and 72 h. Based on these scores the test material does not fulfil the classification criteria for skin irritation according to Regulation (EC) No 1272/2008.
- Executive summary:
Purpose
The purpose of this assay was to identify the skin irritation/corrosion potential of the test item when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. This study was conducted according to Good Laboratory Practice (GLP) and followed the OECD Guideline for Testing of Chemicals No 404. This study should provide a rational basis for risk assessment to the irritating potential of the test item in human.
Study Design
To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with two further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily up to day 15 of the experimental phase.
Results
Erythema (scores 1 and 2) and edema (scores 1 and 2) were seen at the application sites from experimental day 1 up to experimental day 13. Strong redness around the application sites was observed from experimental day 6 up to experimental day 8.
Leathery skin at the application sites and around were observed from experimental day 6 up to experimental day 12 followed by the formation of scales up to the end of the experimental part of the study.
The evaluation of the mean scores of all animals is shown below:
time (h) 1 24 48 72
Erythema 1 1 1 1
Edema 1 1.33 0.33 0.33
Conclusion
Based on the edema and erythema scores of < 2.3, the test material is not classified as a skin irritant according to Regulation (EC) No 1272/2008.
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.
