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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 to 24 April 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ETAD (Ecological and Toxicological of the Dyestuffs Manufacturing Industry) Method n°003
Deviations:
yes
Remarks:
some parameters, like the age of animals at study initiation, were not reported. Only the 24- and 72-h examination were performed (the 48-h examination was lacking).
Principles of method if other than guideline:
Method: other: ETAD (Ecological and Toxicological of the Dyestuffs Manufacturing Industry) Method n°003
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibenzylbenzene, ar-methyl derivative
EC Number:
258-649-2
EC Name:
Dibenzylbenzene, ar-methyl derivative
Cas Number:
53585-53-8
Molecular formula:
C21H20
IUPAC Name:
dibenzylbenzene, ar-methyl derivative

Test animals / tissue source

Species:
rabbit
Strain:
other: New-Zealand
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: not reported
- Weight at study initiation: 2 - 2.5 kg
- Housing: individually in polystyrene cage (0.55 mm x 0.35 mm x 0.32 mm)
- Diet (e.g. ad libitum): commercial diet
- Water (e.g. ad libitum): ad libitum in 1500- or 2000-mL feeding bottle
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 50 +/- 20
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 21 April To: 24 April 1981

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
The eyes were not rinsed after administration of the test substance
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no
- SCORING SYSTEM: treated eyes were scored for conjunctival lesions and discharge, iris lesions and corneal lesions.

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:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
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:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
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
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
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:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
not irritating
Other effects:
No clinical signs were mentioned.

Any other information on results incl. tables

- Iris was unaffected at any observation time.


- Corneal opacity was noted in one rabbit 24h after instillation. It persisted at 48h but vanished at 72h.


- Conjunctival findings: Redness was observed in all rabbits 1h after instillation (two had a score of 1 and four had a score of 2). At 24h, only one animal still presented a score 1 redness. Afterwards, it was no more observed.


- A grade 2 chemosis was present in 3 animals at 1h. It retroceded and was absent at 24h.


- An important discharge (grade 3) was observed in one rabbit, 3 exhibited a moderate discharge (grade 2) and another one had a slight discharge (grade 1). No discharge were found any more thereafter


- CLINICAL FINDINGS: No observed effects


- MORTALITY: No deaths occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this eye irritation study, the substance should not be classified as irritating to eyes according to the criteria for classification laid down in Directive 67/548/EEC.
Executive summary:

The eye irritation potential of the substance was determined in rabbits according to method No. 003 of ETAD (Ecological and toxicological of the Dyestuffs manufacturing Industry) from 1976.


A single application of 0.1 ml of dibenzyltoluene in its original form was placed into the cunjonctival sac of the eye of six male New-Zealand rabbits. The eye was not rinsed after instillation of the test substance. The ocular reactions were observed one hour, 24, 48 and 72 hours after the instillation.


A few ocular reactions (conjunctival chemosis and enanthema) were observed among the animals however these findings were slight (maximum score of 1) and totally reversible within 48 -72h . Thus, the substance should not be classified as irritating to eyes according to the criteria for classification laid down in Directive 67/548/EEC.