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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.
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