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EC number: 600-558-0 | CAS number: 104358-16-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 MAR 2007 - 13 JUL 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD TG 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4'-trans-propyl-1,1'-bicyclohexyl-4-trans-carboxaldehyde
- EC Number:
- 600-558-0
- Cas Number:
- 104358-16-9
- Molecular formula:
- C16H28O
- IUPAC Name:
- 4'-trans-propyl-1,1'-bicyclohexyl-4-trans-carboxaldehyde
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: 37 weeks
- Weight at study initiation: 4.82 kg
- Housing: Animals were kept separately in special rabbit cages (manufacturer: Becker; type K99/30 KU). The collection pans underneath the cages were cleaned at least three times per week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 -19 °C
- Humidity (%): 45 - 53 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
IN-LIFE DATES: From: To: day 1 day 8
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: aqua pro injectione
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g mixed with some droplets aqua pro injectione spread on 6 cm²
VEHICLE
- Amount(s) applied (volume or weight with unit): some drops
- Lot/batch no. (if required): 189 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour after removal of the patches, after 24, 48, 72 hours, and then daily up to experimental day 8.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage: 100 %
- Type of wrap if used: self-adhesive fabric (Fixomull® stretch, Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no (wiped off)
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Under the conditions of the present study no signs of irritation were seen.
- Other effects:
- Symptoms
No signs of clinical toxicity were detected.
Mortality
All animals survived the observation period.
Body weight
Body weight development of the treated rabbits was inconspicuous.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- Under the conditions of the present study no signs of irritation were seen.
- Executive summary:
The current study was performed under GLP-compliance according to the OECD Guideline for Testing of Chemicals, No. 404 and the recommendations of DRAIZE (1959). To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm² patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semi-occlusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with two further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 7 days. Under the conditions of the present study no signs of irritation were seen.
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