Registration Dossier
Registration Dossier
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: 600-299-3 | CAS number: 102322-83-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 - 20 Nov 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No information on purity was given. Observation period was only 7 days.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- no data on test substance purity given, post-observation time not long enough to confirm supposed reversibility
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Hepten-4-one, 5-methyl-, (2E)-
- EC Number:
- 600-299-3
- Cas Number:
- 102322-83-8
- Molecular formula:
- C8H14O
- IUPAC Name:
- 2-Hepten-4-one, 5-methyl-, (2E)-
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 12-16 weeks
- Weight at study initiation: 2.19-3.00 kg
- Housing: animals were housed individually in suspended metal cages
- Diet: Rabbit Diet (A.W. Tindall Limited, Holbeach, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 45-50
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: unchanged (100% test substance) and absolute ethanol (25, 5 and 1% test substance)
- Controls:
- other: Untreated sites of the same animal served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: 1, 5, 25 and 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: area on the back (four suitable test sites were selected)
- Type of wrap: The test substance was applied to the skin and covered with a patch which consisted of a 2.5 cm square of surgical gauze two layers thick. The loaded patch was held in contact with one of the selected test sites with two lengths of Sleek adhesive strapping (Smith & Nephew Limited) in the form of a cross. Additionally, the trunk was wrapped in an elasticated corset (TUBIGRIP).
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance by gentle swabbing with cotton wool soaked in ether.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 100% test substance
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 100% test substance
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 100% test substance
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 100% test substance
- Irritant / corrosive response data:
- 100% test substance:
The test substance produced severe cutaneous irritation in all rabbits. Well-defined erythema with severe oedema extending beyond the treatment site was noted at all treated skin sites 1 h after removal of the patches. Moderate to severe erythema with slight to severe oedema extending beyond the test sites continued to be noted at all treated skin sites up to 72 h after treatment. Observation on Day 7 revealed very slight erythema in 2 animals. Hyperkeratinisation and desquamation was noted in all treated skin sites at this time.
25% test substance:
The test substance produced distinct cutaneous irritation in all rabbits. Well-defined erythema with slight to severe oedema extending beyond the test sites was noted at all treated skin sites 1 hour after removal of the patches. The erythema increased slightly at the 24-hour reading to show moderate to severe erythema at one treated site and well-defined erythema in a further two treated skin sites. The erythema continued and well-defined erythema was noted in 2/3 treated skin sites at the 72-hour observation; barely perceptible erythema was noted in the remaining test site. The oedema gradually regressed and very slight to slight oedema was noted in 2/3 treated skin sites at the 72-hour observation. Hyperkeratinisation was noted in 2/3 treated skin sites on Day.7. All test sites showed desquamation extending beyond the test site at this time.
5% test substance:
The test substance produced minimal cutaneous irritation in 3/3 rabbits. Barely perceptible erythema with minimal oedema was noted at all treated skin sites 1 h after removal of the patches. The erythema quickly regressed and all skin sites appeared normal at subsequent observations.
1% test substance:
The test substance produced minimal cutaneous irritation in 2/3 rabbits. Barely perceptible erythema with minimal oedema was noted at 2/3 treated skin sites 1 h after removal of the patches. The erythema quickly regressed and all skin sites appeared normal at subsequent observations.
Any other information on results incl. tables
Table 1. Results of the skin irritation study following 4 h exposure with undiluted test substance.
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
3 |
4 |
3 |
4 |
3 |
4 |
24 h |
3 |
4 |
3 |
4 |
3 |
4 |
48 h |
3 |
2 |
3 |
4 |
3 |
4 |
72 h |
3 |
2 |
3 |
2 |
3 |
4 |
7 days |
1HD |
0 |
1HD |
0 |
0HD |
0 |
Mean value |
3.0 |
2.7 |
3.0 |
3.3 |
3.0 |
4.0 |
H: hyperkeratinisation
D: desquamation
Table 2. Results of the skin irritation study following 4 h exposure with test substance at concentration of 25% (v/v) in absolute ethanol.
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
2 |
2 |
2 |
4 |
2 |
4 |
24 h |
2 |
1 |
2 |
2 |
3 |
4 |
48 h |
2 |
1 |
2 |
1 |
2 |
4 |
72 h |
1 |
0 |
2 |
1 |
2 |
2 |
7 days |
0D |
0 |
0HD |
0 |
0HD |
0 |
Mean value |
1.7 |
0.7 |
2.0 |
1.3 |
2.3 |
3.3 |
H: hyperkeratinisation
D: desquamation
Table 3. Results of the skin irritation study following 4 h exposure with test substance at concentration of 5% (v/v) in absolute ethanol.
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
1 |
0 |
1 |
1 |
1 |
0 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value |
0 |
0 |
0 |
0 |
0 |
0 |
Table 4. Results of the skin irritation study following 4 h exposure with test substance at concentration of 1% (v/v) in absolute ethanol.
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
0 |
0 |
1 |
1 |
1 |
1 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Irrit. Cat. 2 at 100% test substance
- Remarks:
- according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of this skin irritation study in rabbits the test substance at concentration of 100% was irritating to the skin. Concentrations of 1, 5 and 25% of the test substance were considered not irritating to skin.
- Executive summary:
A skin irritation study was performed according to OECD 404 and GLP. The primary irritation test in rabbits was performed at 1, 5, 25 and 100 % in Ethanol.
The mean values for 24-72 hours in 3 rabbits for 1% and 5% in Ethanol were all 0.0. The mean values in 3 rabbits for 25% in Ethanol were for erythema 1.7, 2.0 and 2.3, for edema 0.7, 1.3 and 3.3.
Mean values for the pure test item at 24-72 hours in 3 rabbits: Erythema 3.0, 3.0, 3.0; edema 2.67, 3.33, 4.0, not fully reversible after 7 days. The post-observation time was only 7days and was not long enough to confirm supposed reversibility.
Under the conditions of this skin irritation study in rabbits the test substance at concentration of 100% was irritating to the skin. Concentrations of 1, 5 and 25% of the test substance were considered not irritating to skin.
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.
