Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
