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Registration Dossier
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EC number: 234-091-5 | CAS number: 10528-67-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-07-21 to 2003-08-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- α-methylcyclohexanepropanol
- EC Number:
- 234-091-5
- EC Name:
- α-methylcyclohexanepropanol
- Cas Number:
- 10528-67-3
- Molecular formula:
- C10H20O
- IUPAC Name:
- 4-cyclohexylbutan-2-ol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Chbb:HM(SPF) - Littlerussian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 17 to 20 months
- Weight at study initiation: 2.7 — 3.1 kg b. w.
- Housing: individually in PPO cages (floor area: 2576 sq. cm) with perforated floor
- Diet: ad libitum, Altromin 2123" from Altromin, D-32791 Lage, Lippe
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted (100 %) - Duration of treatment / exposure:
- 3 min, 1 (for 1 animal) and 4 h (for all 3 animals)
- Observation period:
- immediately and after 1, 24, 48, 72 h and 7, 14, 21 days
- Number of animals:
- 1 animal (3min, 1 and 4 h), 2 animals (4 h)
- Details on study design:
- TEST SITE
- Area of exposure: back skin, 2.5 x 2.5 cm
- Type of wrap if used: 16-layer gauze patch secured with adhesive Gothaplast tape and Gothaplast tape wound around the trunk of the animal
REMOVAL OF TEST SUBSTANCE
- Washing: mild soap and lukewarm water
- Time after start of exposure: after exporsure time was over test field was marked and directly washed
SCORING SYSTEM:
- Erythema and Eschar Formation: 1-4
- Oedema Formation: 1-4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: exposure time 4 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: exposure time 4 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: exposure time 4 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: exposure time 4 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: exposure time 4 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: exposure time 4 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: exposure time 4 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: exposure time 4 h
Any other information on results incl. tables
Results of Animal 1 after 3 min and 1 h exposure:
| Exposure time | Timepoint of observation [h] | Erythema score (of max. 4) | Edema score (of max. 4) |
| 3 min | 0 | 2 | 0 |
| 1 | 1 | 0 | |
| 24 | 2 | 0 | |
| 48 | 1 | 0 | |
| 72 | 0 | 0 | |
| 1 h | 0 | 2 | 0 |
| 1 | 1 | 0 | |
| 24 | 2 | 2 | |
| 48 | 2 | 2 | |
| 72 | 2 | 2 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test substance was determined to cause skin irritation in rabbits.
- Executive summary:
The skin irritant effect of the test substance was investigated according to OECD Guideline 404. During an initial test using one female albino rabbit a sequential application (exposure time 3 min, 1 h and 4 h) of the test substance was carried out on one site of the left back area. The skin was examined for signs of irritation directly after application as well as 1 h, 24 h, 48 h and 72 h after the termination of exposure as well as on day 7, 14 and 21. Since the animal did show very well defined but reversible signs of skin irritation within the observation period of 21 days it was decided to carry out a confirmatory test with two additional animals in order to allow a categorization of the test item based on the classification criteria. Two female albino rabbits were exposed to the test item at one skin site on the backs during the confirmatory test. After 4 hour exposure time the test item was removed and the skin was examined 1 h, 24 h, 48 h and 72 h after the termination of exposure as well as on day 7, 14 and 21. Very well defined skin reactions were observed in these animals, too. All effects were fully reversible within 21 days. Under the experimental conditions described, the mean score (24/48/72h) for erythema was 2.9 and for edema 2.3. For individual animals the erythema score for 24/48/72h was 3 for animals 1 and 2 and 2.67 for animal 3. The edema score for individual animals at 24/48/72h was 3 for animal 1 and 2 for animals 2 and 3. Considering these results the test substance was determined to be irritating to the skin.
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