Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1993-02-24 to 1993-02-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted February 24, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
84/449/EEC
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 12 weeks
- Weight at study initiation: 2689 - 2993 g
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system.
- Diet: Standard laboratory rabbit diet (LKK-20, peller diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day.
- Water: Free access to tap-water diluted with decalcified water.
- Acclimation period: at least five days before start of treatment under test conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as reference control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 64 ± 1 mg per animal
Duration of treatment / exposure:
single treatment for 24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
SCORING SYSTEM: according to EU and OECD guidelines (Draize system)

TOOL USED TO ASSESS SCORE: fluorescein, pocket flash light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.56
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Instillation of the test substance into one eye of each of the three male albino rabbits affected the conjunctivae. The irritation of the conjunctivae had resolved within 48 h in one animal and within 72 h after instillation in the two other animals. Treatment of the eyes with 2% fluorescein, 24 h after test substance instillation revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion.
Other effects:
No staining of per-ocular tissues by the test substance was observed. No toxic symptoms were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
1,1'-(1,1,2,2-tetramethylethylene)dibenzene resulted in a slight conjunctivae redness which was reversible within at least 72 h (mean score 24/48/72 h: 0.33 - 0.67), when applied to the rabbits eye. No adverse effects were observed for parameters cornea, iris and discharge (score 0 in all animals).
Executive summary:

The eye irritation potential of 1,1'-(1,1,2,2-tetramethylethylene)dibenzene was assessed according to OECD guideline 405 and EU method B.5. The test item was instilled into one eye of each of three male albino rabbits (New Zealand White), followed by four observations at approximately 1, 24, 48 and 72 h after test substance administration. Under the conditions of the study, 1,1'-(1,1,2,2-tetramethylethylene)dibenzene resulted in adverse effects on the conjunctivae in all three animals, which had resolved within 48 - 72 h after instillation (mean score 24/48/72 h: 0.33 - 0.67). Ocular corrosion was not observed in any of the rabbits. No signs of systemic intoxication were observed during the study period. In conclusion, 1,1'-(1,1,2,2-tetramethylethylene)dibenzene was considered as not irritating to the eye.