Registration Dossier
Registration Dossier
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EC number: 406-700-6 | CAS number: 78531-61-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.03.1990 to 12.03.1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(trans-4-propylcyclohexyl)acetophenone
- EC Number:
- 406-700-6
- EC Name:
- 4-(trans-4-propylcyclohexyl)acetophenone
- Cas Number:
- 78531-61-0
- Molecular formula:
- Hill formula: C17H24O CAS formula: C17H24O
- IUPAC Name:
- 1-[4-(4-propylcyclohexyl)phenyl]ethan-1-one
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: 16 - 17 weeks
- Weight at study initiation: 3.10 (3.04 - 3.21) kg
- Housing: KK 017 (floor area: 75 x 54.5 = 4087 cm2, height: 38 cm; manufacturer: Hulskamp)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24
- Humidity (%):41 to 56
- Air changes (per hr): not specified but, air-conditioned room
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 05.03.1990 until 12.0.3.1990
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g test item, were moistened with water (aqua pro injectione) and were spread onto 4 cm 2 patches.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- The rabbits were examined for skin alterations, behaviour and general condition 1 hour after removal of the patches, after 24, 48 and 72 hours, and then daily up to experimental day 8.
- Number of animals:
- 3 (2 female, 1 male)
- Details on study design:
- TEST SITE
- Area of exposure: left side of animal's back
- Type of wrap if used: polyethylene foil which was kept in place by a leather sleeve.
REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1 hour, 24, 48, 72 hours and then daily up to experimental day 8 after patch removal
SCORING SYSTEM:
- Method of calculation: Draize scheme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin irritating potential could be detected.
- Other effects:
- - Other adverse local effects: none
- Other adverse systemic 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:
- GHS criteria not met
- Conclusions:
- The test item is considered to be not irritating to skin.
- Executive summary:
The skin irritation potential of the test item was investigated according to OECD Guideline 404 under GLP conditions. An amount of 0.5 g of the test material was mixed with several drops of Aqua pro injectione to ensure good skin contact. The initial test with one animal and the confirmatory test with two further animals showed no signs of irritation at the treated areas following single application to the intact dorsal skin of rabbits for 4 hours under occlusive conditions. No signs of clinical toxicity were detected. All animals survived the observation period. Body weight development of the treated rabbits was inconspicuous. Under the conditions of the present study no signs of irritation were seen.
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