Registration Dossier
Registration Dossier
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EC number: 266-767-0 | CAS number: 67601-05-2
Eye irritation
Administrative data
- Endpoint:
- eye 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 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
- 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 / 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:
- yes, concurrent no treatment
- 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
- 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)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity 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:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis 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:
- see table 1.
Any other information on results incl. tables
Table 1: 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
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not found to be irritant to the eye when tested in vivo on rabbits.
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