Registration Dossier
Registration Dossier
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: 202-425-9 | CAS number: 95-50-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- March to April 1979
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ETAD guideline
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,2-dichlorobenzene
- EC Number:
- 202-425-9
- EC Name:
- 1,2-dichlorobenzene
- Cas Number:
- 95-50-1
- Molecular formula:
- C6H4Cl2
- IUPAC Name:
- 1,2-dichlorobenzene
- Details on test material:
- Analytical purity: 1,2-dichlorobenzene, chemically pure (no further data)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill, Huntingdom, Great Britain
- Weight at study initiation: 3-4 kg
- Housing: separately in standard cages
- Diet (e.g. ad libitum): Z 222 from Hönig, Verden/Aller, Germany, ad libitum
- Water (e.g. ad libitum): ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- 1h, 24h, 48h, 72h and 7 days after instillation
- Number of animals or in vitro replicates:
- six
- Details on study design:
- SCORING SYSTEM:
According to guideline
In addition, discharge was also observed according to the following scheme:
- Conjunctivae:
Discharge:
0 : No discharge
1 : Any amount different from normal (does not include small amounts observed in innner canthus of normal animals)
2 : Discharge with moistening of the lids and hairs just adjacent to lids
3 : Discharge with moistening of the lids and hairs, and considerable area around the eye
TOOL USED TO ASSESS SCORE:
hand-slit lamp and fluorescein (only if there was doubt regarding corneal damage or opacity)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation could be observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.06
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.61
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- other: Discharge
- Basis:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no discharge could be observed
- Other effects:
- not reported
Any other information on results incl. tables
Table: Grading results of ocular lesions after 1,2 -dichlorobenzene administration to rabbits
| Animal No. / Eye | Symptoms | Time points for grading of ocular lesions | ||||
| 1 hour | 24 hours | 48 hours | 72 hours | 7 days | ||
| 9 / right | Cornea * | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Iris | 0 | 0 | 0 | 0 | 0 | |
| Conjunctivae | 1 | 1 | 1 | 0 | 0 | |
| Chemosis | 0 | 0 | 0 | 0 | 0 | |
| Discharge | 0 | 0 | 0 | 0 | 0 | |
| 14 / right | Cornea * | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Iris | 1 | 1 | 0 | 0 | 0 | |
| Conjunctivae | 1 | 1 | 1 | 0 | 0 | |
| Chemosis | 0 | 0 | 0 | 0 | 0 | |
| Discharge | 0 | 0 | 0 | 0 | 0 | |
| 10 / right | Cornea * | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Iris | 0 | 0 | 0 | 0 | 0 | |
| Conjunctivae | 1 | 1 | 1 | 0 | 0 | |
| Chemosis | 1 | 1 | 0 | 0 | 0 | |
| Discharge | 0 | 0 | 0 | 0 | 0 | |
| 17 / right | Cornea * | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Iris | 0 | 0 | 0 | 0 | 0 | |
| Conjunctivae | 1 | 1 | 1 | 0 | 0 | |
| Chemosis | 0 | 0 | 0 | 0 | 0 | |
| Discharge | 0 | 0 | 0 | 0 | 0 | |
| 18 / right | Cornea * | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Iris | 0 | 0 | 0 | 0 | 0 | |
| Conjunctivae | 1 | 1 | 1 | 0 | 0 | |
| Chemosis | 0 | 0 | 0 | 0 | 0 | |
| Discharge | 0 | 0 | 0 | 0 | 0 | |
| 22 / right | Cornea * | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| Iris | 0 | 0 | 0 | 0 | 0 | |
| Conjuntivae | 1 | 1 | 0 | 0 | 0 | |
| Chemosis | 1 | 1 | 0 | 0 | 0 | |
| Discharge | 0 | 0 | 0 | 0 | 0 | |
| Average over all animals | Cornea * | -- | 0 / 0 | -- | ||
| Iris | -- | 0.06 | -- | |||
| Conjunctivae | -- | 0.61 | -- | |||
| Chemosis | -- | 0.11 | -- | |||
| Discharge | -- | 0 | -- | |||
* : Opacity-degree of density / Area of cornea involved
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the harmonised classification - Annex VI of Regulation (EC) No 1272/2008 (CLP regulation) a classification is not justified.
- Executive summary:
Thyssen, 1979 (Bayer study)
An acute eye irritation/corrosion study was conducted according to ETAD guideline and similar to OECD Guideline 405 without deviations.
0.1 mL 1,2-dichlorobenzene were administered to six New Zealand White rabbits. Observation time points were 1h, 24h, 48h and 72h and 7 days after instillation.
For time points 24h, 48h and 72h the mean value over all animals was for the:
- cornea score: 0 (no irritation could be observed),
- iris score: 0.06 (effects were fully reversible within 72h),
- conjunctivae score: 0.61 (effects were fully reversible within 72h),
- chemosis score: 0.11 (effects were fully reversible within 72h) and
- discharge score: 0 (because no discharge could be observed).
According to the harmonised classification - Annex VI of Regulation (EC) No 1272/2008 (CLP regulation) a classification is not justified.
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.
