Registration Dossier
Registration Dossier
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EC number: 266-767-0 | CAS number: 67601-05-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Citronellyl acetate
- EC Number:
- 205-775-0
- EC Name:
- Citronellyl acetate
- Cas Number:
- 150-84-5
- IUPAC Name:
- 3,7-dimethyloct-6-en-1-yl acetate
- Test material form:
- liquid
- Details on test material:
- Designation: CITRONELLYL ACETATE EXTRA
Appearance: colourless to pale yellowish liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DR. K. Thomae GmbH, Biberach
- Age at study initiation: young adult
- Animal identification: ear tattoo
- Weight at study initiation: female: 3.76 kg; male: 3.41 and 3.48 kg
- Housing: single housing, stainless stell wire mesh cages with grating, floor area: 3000 cm2
- Bedding: no bedding in the cages; sawdust in the waste trays
- Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water: Tap Water (about 250 ml/animal/day)
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 ml on intact untreated skin
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 15 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Preparation: at least 24 h before the test, the fur was removed by clipping the dorsal of the trunk of the animal; only animals with healthy/intact skin were used
- Area of exposure: upper third of back or flanks
- Application: 2.5 x 2.5 cm test patch moistened with 0.5 ml of the test substance
- Type of wrap if used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adheasive Fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol (BASF SE) and Lutrol in water (1:1)
- Time after start of exposure: 4 h
READING
- 1 h, 24 h, 48 h, 72 h, 8 d and 15 d after patch removal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
Any other information on results incl. tables
For calculation of the means only the 24, 48 and 72 hours readings were taken into consideration.
Irritant response data:
| Readings | Animal | Exposure period: 4 h | ||
| Erythema | Edema | Additional findings | ||
| 1h | 1 | 2 | 1 | |
| 2 | 2 | 1 | ||
| 3 | 2 | 1 | ||
| 24 h | 1 | 3 | 2 | |
| 2 | 3 | 1 | ||
| 3 | 3 | 1 | ||
| 48 h | 1 | 3 | 1 | |
| 2 | 2 | 1 | ||
| 3 | 2 | 1 | ||
| 72 h | 1 | 3 | 0 | |
| 2 | 2 | 0 | ||
| 3 | 2 | 0 | ||
| 8 d | 1 | 1 | 0 | scaling |
| 2 | 0 | 0 | scaling | |
| 3 | 0 | 0 | scaling | |
| 15 d | 1 | 0 | 0 | scaling |
| 2 | 0 | 0 | ||
| 3 | 0 | 0 | ||
| Mean 24 - 72 h | 1 | 3 | 1 | |
| 2 | 2.3 | 0.7 | ||
| 3 | 2.3 | 0.7 | ||
| Mean | 2.5 | 0.8 | ||
Animal 1: female; animal 2: male; animal 3: male
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- According to the study, the test subtance was found to be irritant on rabbits and is classified as Category 2.
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