Registration Dossier
Registration Dossier
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EC number: 249-854-8 | CAS number: 29797-40-8
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dichloromethylbenzene
- EC Number:
- 249-854-8
- EC Name:
- Dichloromethylbenzene
- Cas Number:
- 29797-40-8
- Molecular formula:
- C7H6Cl2
- IUPAC Name:
- (dichloromethyl)benzene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the test substance was applied to one eye, the other eye was not treated and served as control
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no symptom seen
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no symptom seen
- Irritation parameter:
- other: Conjunctiva reddening
- Basis:
- animal #1
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Remarks on result:
- other: Conjunctiva reddening
- Irritation parameter:
- other: Conjunctiva swelling
- Basis:
- animal #1
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: Conjunctiva swelling
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no symptom seen
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no symptom seen
- Irritation parameter:
- other: Conjunctiva reddening
- Basis:
- animal #2
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: Conjunctiva reddening
- Irritation parameter:
- other: Conjunctiva swelling
- Basis:
- animal #2
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: Conjunctiva swelling
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no symptoms seen
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no symptoms seen
- Irritation parameter:
- other: Conjunctiva reddening
- Basis:
- animal #3
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Remarks on result:
- other: Conjunctiva reddening
- Irritation parameter:
- other: Conjunctiva swelling
- Basis:
- animal #3
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Conjunctiva swelling
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score = = at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable - score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
Any other information on results incl. tables
Results:
| DRAIZE-Grade | ||||||||||
| Animal No./ bw/ sex | examined organ | symptom | 1h | 24h | 48h | 72h | 7d | 14d | 21d | Irritation score |
| E11 (3.6 kg) female | Cornea | -cloudiness | 0 | 0 | 0 | 0 | 0 | - | - | 0.0 |
| -area | 0 | 0 | 0 | 0 | 0 | - | - | / | ||
| Iris | 0 | 0 | 0 | 0 | 0 | - | - | 0.0 | ||
| Conjunctivae | reddening | 1 | 1 | 1 | 1 | 0 | - | - | 1.0 | |
| swelling | 2 | 1 | 0 | 0 | 0 | - | - | 0.3 | ||
| lacrimation | 2 | 1 | 0 | 0 | 0 | - | - | / | ||
| C40 (3.2 kg) female | Cornea | -cloudiness | 0 | 0 | 0 | 0 | 0 | - | - | 0.0 |
| -area | 0 | 0 | 0 | 0 | 0 | - | - | / | ||
| Iris | 0 | 0 | 0 | 0 | 0 | - | - | 0.0 | ||
| Conjunctivae | reddening | 1 | 1 | 1 | 0 | 0 | - | - | 0.7 | |
| swelling | 1 | 1 | 1 | 0 | 0 | - | - | 0.7 | ||
| lacrimation | 1 | 1 | 0 | 0 | 0 | - | - | / | ||
| O41 (3.5 kg) female | Cornea | -cloudiness | 0 | 0 | 0 | 0 | 0 | - | - | 0.0 |
| -area | 0 | 0 | 0 | 0 | 0 | - | - | / | ||
| Iris | 0 | 0 | 0 | 0 | 0 | - | - | 0.0 | ||
| Conjunctivae | reddening | 1 | 1 | 1 | 1 | 0 | - | - | 1.0 | |
| swelling | 1 | 0 | 0 | 0 | 0 | - | - | 0.0 | ||
| lacrimation | 1 | 1 | 0 | 0 | 0 | - | - | / | ||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Slight effects were observed, but according to classification and labeling the substance is not irritating to the eye.
- Executive summary:
In an eye irritation study according to OECD guideline 405 the test substance (100 µl) was applied to one eye of 3 New Zealand White rabbits. The other eye was left untreated and served as control. After 24h the treated eyes were rinsed with physiological saline solution. Examinations took place after 1h, 24h, 48h, 72h and 7d and were evaluated according to DRAIZE.
Slight effects were observed, but according to classification and labeling the substance is not irritating to the eye.
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