Registration Dossier
Registration Dossier
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EC number: 235-878-6 | CAS number: 13019-22-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 February 1982 - 02 March 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 163.81-5 Primary dermal irritation study
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dec-9-en-1-ol
- EC Number:
- 235-878-6
- EC Name:
- Dec-9-en-1-ol
- Cas Number:
- 13019-22-2
- Molecular formula:
- C10H20O
- IUPAC Name:
- dec-9-en-1-ol
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: 12 to 16 weeks old
- Weight at study initiation: between 2.3 to 3.0 kg
- Housing: caged individually in stainless steel cages
- Diet (e.g. ad libitum): standard rabbit maintenance feed, ad libitum
- Water (e.g. ad libitum): automatic drinking supply
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours/day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- and slightly scarified
- Vehicle:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 21 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: entire back and the flank
- Type of wrap if used: surgical gauze, aluminium foil (approximately 2.5 x 2.5cm) and occlusive bandage of elastic adhesive dressing
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours, 7, 14 and 21 days
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3.33
- Max. score:
- 3.33
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- >= 0 - <= 3
- Max. score:
- 3
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- primary irritation index
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.6
- Max. score:
- 3.6
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 3.8
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Assessment of irritation:
0 to 0.5: none
0.6 to 3.0: slight
3.1 to 5.0: moderate
5.1 to 8.0: marked
see Table 1 - Other effects:
- In the area of application no discoloration of the skin was observed.
Any other information on results incl. tables
Table 1: results
| erythema | oedema | |||||||||||
| rabbit# | score 24h | score 48h | score 72 h | mean 24 / 48 / 72 | 7 days | 14 days | score 24h | score 48h | score 72 h | mean 24 / 48 / 72 | 7 days | 14 days |
| 835 | 2 | 2 | 3 | 2,333333333 | 2 | 0 | 1 | 1 | 2 | 1,333333333 | 1 | 0 |
| 836 | 2 | 2 | 2 | 2 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 |
| 837 | 2 | 3 | 4 | 3 | 0 | 0 | 2 | 2 | 2 | 2 | 1 | 0 |
| 838 | 2 | 3 | 3 | 2,666666667 | 2 | 0 | 1 | 1 | 1 | 1 | 1 | 0 |
| 839 | 2 | 3 | 4 | 3 | 1 | 0 | 2 | 2 | 2 | 2 | 1 | 0 |
| 840 | 3 | 3 | 4 | 3,333333333 | 3 | 0 | 1 | 1 | 2 | 1,333333333 | 2 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the conditions of this experiment the test material was found to cause moderate irritation when applied to intact and abraded rabbit skin.
In the area of application no discoloration of the skin was observed.
Within 72 hours after starting the application 2 out of 6 rabbits showed necrosis of the skin at the application site. There was a clear tendency of healing during the following observation period.
The calculated primary irritation index was found to be:
- intact skin: 4.0
- abraded skin: 3.3
Mean irritation index for intact and abraded skin: 3.6
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