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Registration Dossier
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EC number: 213-426-9 | CAS number: 947-19-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Sep. 14, 1981 to Sep. 21, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- -protocol with occlusive application for 24h, which is more stringent than the OECD guideline 404, and observation period should be up to 14 days to determine reversibility effects
- GLP compliance:
- no
Test material
- Reference substance name:
- Hydroxycyclohexyl phenyl ketone
- EC Number:
- 213-426-9
- EC Name:
- Hydroxycyclohexyl phenyl ketone
- Cas Number:
- 947-19-3
- Molecular formula:
- C13H16O2
- IUPAC Name:
- 1-benzoylcyclohexan-1-ol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred and raised rabbits on the premises (Ciba-Geigy Ltd. - Exp. Toxicology Sisseln GU 2.1)
- Age at study initiation: Adults
- Weight at study initiation: 2 to 3 kg
- Housing: Housed individually in metal cages
- Diet (e.g. ad libitum): ad libitum, standard rabbit food (NAFAG No. 814, Gossau SG)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: polyethylene glycol (PAG 400) + saline (70:30 parts)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50%
VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): 70:30 parts of polyethylene glycol (PAG 400) + saline - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: Before treatment, the entire back and flank of the rabbits were shaved and immediately before treatment the shaven skin on one side was slightly scarified. The test material was applied to the prepared abraded and intact skin.
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported
- Time after start of exposure: 24 hours
The dressings were removed after a 24 hour application.
SCORING SYSTEM: The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of the following evaluation scheme.
Score for skin irritation in rabbits
Erythema and eschar formation
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well defined erythema - 2
Moderate to severe erythema - 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) - 4
Total possible erythema score - 4
Edema formation
No edema - 0
Very slight edema (barely perceptible) - 1
Slight edema (edges of area well defined by definite raising) - 2
Moderate edema (raised approximately 1 mm) - 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) - 4
Total possible edema score - 4
Assessment of irritation:
0
0.1-1.0 = minimal
1.1-2.0 = slight
2.1-4.0 = moderate
4.1-6.0 = marked
6.1-8.0 = extreme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- overall irritation score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- overall irritation score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.8
- Max. score:
- 8
- Reversibility:
- not specified
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.8
- Max. score:
- 8
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- The test item was found to cause a minimal irritation when applied to intact and abraded rabbit skin.
The primary irritation index was 1.3//0.3 for erythema/edema at 24h and 0.0/0. for erythema/oedema at 72h for intact skin. No further findings on intact skin appeared until the last day of the observation period (day 7). Findings on abraded skin were still observed in one animal on day 7
Any other information on results incl. tables
Table 1. Primary Irritation Score
Time after exposure (hours) |
Mean reaction score |
|||
Erythema |
Edema |
|||
Intact skin |
Abraded skin |
Intact skin |
Abraded skin |
|
24 |
1.0 |
1.3 |
0.3 |
0.3 |
72 |
0 |
0.3 |
0 |
0 |
Total |
1.0 |
1.6 |
0.3 |
0.3 |
The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.
Total = 1.0 + 1.6 + 0.3 + 0.3 = 3.2
Primary irritation index = 3.2 / 4 = 0.8
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be not irritant to the skin under the test conditions.
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