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EC number: 829-246-4 | CAS number: 34212-53-8
Toxicological information
Eye irritation
Currently viewing:
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
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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
- Justification for type of information:
- See attached justification in section 13.2
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Internal BASF method was used
- GLP compliance:
- no
- 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 - 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 - 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
- Remarks on result:
- positive indication of irritation
- 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: 72h
- Remarks on result:
- probability of weak irritation
- 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
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In the study for eye irritation of the test item applied to eyes of two Vienna White rabbits, reactions were evaluated for eight days. As result, mean scores (24, 72 hours) for corneal opacity, conjunctival redness and chemosis were 1.5, 1 and 0.5, for animal 1 and 2.5, 1.5 and 0.5 for animal 2, respectively. Conjunctival redness and corneal opacity were not reversible within the eight day observation period. The test substance has been found to be irritating to eyes under the chosen testing conditions.
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.
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
- Remarks on result:
- positive indication of irritation
- 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: 72h
- Remarks on result:
- probability of weak irritation
- 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
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
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
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In the study for eye irritation of the test item applied to eyes of two Vienna White rabbits, reactions were evaluated for eight days. As result, mean scores (24, 72 hours) for corneal opacity, conjunctival redness and chemosis were 1.5, 1 and 0.5, for animal 1 and 2.5, 1.5 and 0.5 for animal 2, respectively. Conjunctival redness and corneal opacity were not reversible within the eight day observation period. The test substance has been found to be irritating to eyes under the chosen testing conditions.
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