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Toxicological information

Eye irritation

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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:
1979
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

Constituent 1
Chemical structure
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)

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
   Conjunctivae  1
   Chemosis  0
   Discharge  0
 14 / right  Cornea *   0 / 0  0 / 0   0 / 0   0 / 0   0 / 0 
   Iris
   Conjunctivae
   Chemosis
   Discharge 0
 10 / right  Cornea *  0 / 0   0 / 0    0 / 0  0 / 0   0 / 0
   Iris
   Conjunctivae  1
   Chemosis  1
   Discharge  0
 17 / right  Cornea *  0 / 0    0 / 0  0 / 0   0 / 0   0 / 0 
   Iris  0
   Conjunctivae  1
   Chemosis  0
   Discharge
 18 / right  Cornea *  0 / 0    0 / 0   0 / 0  0 / 0    0 / 0
   Iris  0
   Conjunctivae  1
   Chemosis  0
   Discharge  0
 22 / right  Cornea *  0 / 0    0 / 0   0 / 0   0 / 0   0 / 0
   Iris
   Conjuntivae  0
   Chemosis  0  0
   Discharge  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.