Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-623-8 | CAS number: 108-86-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Please refer to the analogue approach justification document provided in section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 02 Oct 2012
- Deviations:
- yes
- Remarks:
- no topical anesthetics and systemic analgesics were used; no initial test was performed
- GLP compliance:
- no
Test material
- Reference substance name:
- Chlorobenzene
- EC Number:
- 203-628-5
- EC Name:
- Chlorobenzene
- Cas Number:
- 108-90-7
- Molecular formula:
- C6H5Cl
- IUPAC Name:
- chlorobenzene
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: about 3000 g
- Housing: individual housing under standardized coditions
- Diet: Ssniff K (Versuchstierdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 100%
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was rinsed with NaCl solution
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- All animals showed mild to moderate (graded with scores of 1 - 2) conjunctival redness and swelling after test substance instillation. In one animal slight opacity of the cornea was observed at the 1 and 24 h reading time points. All effects were fully reversible latest within 7 days. No further substance-related effects were observed.
Any other information on results incl. tables
Table 1: Individual scores
| Rabbit # | Time [h] | conjunctivae | iris | cornea | |
| redness | swelling | ||||
| 1 | 1 | 1 | 1 | 0 | 0 |
| 24 | 1 | 1 | 0 | 0 | |
| 48 | 1 | 0 | 0 | 0 | |
| 72 | 1 | 0 | 0 | 0 | |
| average | 1.0 | 0.3 | 0.0 | 0.0 | |
| 2 | 1 | 2 | 1 | 0 | 1 |
| 24 | 2 | 1 | 0 | 1 | |
| 48 | 1 | 1 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| average | 1.0 | 0.7 | 0.0 | 0.3 | |
| 3 | 1 | 1 | 1 | 0 | 0 |
| 24 | 1 | 1 | 0 | 0 | |
| 48 | 1 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| average | 0.7 | 0.3 | 0.0 | 0.0 | |
| Time [h] | conjunctivae | iris | cornea | ||
| redness | swelling | ||||
| average score |
1 | 1.33 | 1.00 | 0.00 | 0.33 |
| 24 | 1.33 | 1.00 | 0.00 | 0.33 | |
| 48 | 1.00 | 0.33 | 0.00 | 0.00 | |
| 72 | 0.33 | 0.00 | 0.00 | 0.00 | |
| 24+48+72 | 0.89 | 0.44 | 0.00 | 0.11 | |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008.
- Conclusions:
- CLP: not classified
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
