Registration Dossier
Registration Dossier
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EC number: 205-775-0 | CAS number: 150-84-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted in accordance with GLP.
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 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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
- Molecular formula:
- C12H22O2
- IUPAC Name:
- 3,7-dimethyloct-6-en-1-yl acetate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Citronellylacetat
- Substance number: 94/369
- Physical state: liquid
- Appearance: achromatic
- Analytical purity: 98.8%
- Lot/batch No.: Lot Nr. 4 + 5, Abl. Nr. 08-0194
- Stability under test conditions: stable over testing period (acc. to reanalysis)
- Storage condition of test material: refrigerator, exclusion of light, tightly closed
- Other: manufatory date: 24-05-1994
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: young adults
- Animal identification: ear tattoo
- Weight at study initiation: females 3.60 kg, 3.96 kg; male 3.98 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml in single application to conjunctival sac of right eyelid - Duration of treatment / exposure:
- once continously
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
GENERAL OBSERVATIONS
- check for dead or moribund animals: twice daily (Mo - Fr), once daily (Sa/Su)
SCORING SYSTEM:
-according to OECD guideline 405 (adopted Feb. 24, 1987) and EEC L 383A, B.5 (Dec. 29, 1992)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals tested
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals tested
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals tested
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals tested
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
For calculation of the means of opacity, iris, redness and swelling, the 24, 48 and 72 hours readings were taken into consideration.
Irritant response data:
| Readings | Animal | cornea | Iris | conjunctiva | Symptoms | |||
| opacity | area | redness | swelling | discharge | ||||
| 1 h | 1 | 0 | 0 | 0 | 1 | 0 | 2 | - |
| 2 | 0 | 0 | 0 | 1 | 0 | 1 | - | |
| 3 | 0 | 0 | 0 | 1 | 0 | 1 | - | |
| 24 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | - |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | - | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | - | |
| 48 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | - |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | - | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | - | |
| 72 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | - |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | - | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | - | |
| Mean 24 - 72 h | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Mean | 0 | 0 | 0 | 0 | 0 | 0 | ||
Animal 1: female; animal 2: female; animal 3: male
Applicant's summary and conclusion
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.
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