Registration Dossier
Registration Dossier
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EC number: 203-518-7 | CAS number: 107-75-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles, not according to current guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
- Principles of method if other than guideline:
- Internal BASF method was used
- GLP compliance:
- no
Test material
- Reference substance name:
- 7-hydroxycitronellal
- EC Number:
- 203-518-7
- EC Name:
- 7-hydroxycitronellal
- Cas Number:
- 107-75-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 7-hydroxy-3,7-dimethyloctanal
- Details on test material:
- - Name of test material (as cited in study report): Hydroxycitronellal (HCA); 3.7-Dimethyl-7-hydroxyoctanol-1
- Physical state: liquid
- Purity: approx. 99%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male 3.19 kg, female 3.44 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: NaCl into other eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): 100% - Duration of treatment / exposure:
- continuously
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM:
Gradings for corneal opacity, conjunctival redness and chemosis were converted into numerical grading system acc. to Draize.
Chemosis (Swelling) and cornea (Opacity):
0 = none
1 = slight
2 = well defined
3 = severe
4 = very severe
Conjunctival redness (Redness):
0 = normal
1 = slight
2 = well defined
3 = severe
4= very severe
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 72 h
- Score:
- 1.25
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
Any other information on results incl. tables
Animal 1: male
Animal 2: female
Results:
| Readings | Animal | Erythema | chemosis | Corneal opacity | Additional findings |
| 1h | 1 | 2 | 1 | 1 | miosis |
| 2 | 2 | 3 | 2 | miosis | |
| 3 h | 1 | 2 | 1 | 1 | discharge |
| 2 | 2 | 2 | 2 | discharge | |
| 24 h | 1 | 1 | 1 | 2 | mucosal hemorrhages |
| 2 | 2 | 1 | 2 | mucosal hemorrhages | |
| 72 h | 1 | 1 | 0 | 1 | mucosal hemorrhages |
| 2 | 1 | 0 | 3 | mucosal hemorrhages, scar | |
| 4 d | 1 | 1 | 0 | 1 | mucosal hemorrhages |
| 2 | 1 | 0 | 3 | mucosal hemorrhages, scar | |
| 7 d | 1 | 1 | 0 | 1 | |
| 2 | 1 | 0 | 1 | scar | |
| 8 d | 1 | 1 | 0 | 1 | |
| 2 | 1 | 0 | 1 | scar | |
| Mean 24 - 72 h | 1 | 1 | 0.5 | 1.5 | |
| 2 | 1.5 | 0.5 | 2.5 | ||
| Mean | 1.25 | 0.5 | 2 |
No effects reported for iris.
No effects observed for eyes treated with NaCl.
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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