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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
Centre International de Toxicologie, France

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,6 DCPTFMA
- Physical state: solid
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole du Val de Selle, 80160 Prouzel, France
- Weight at study initiation: mean: 2.8 ± 0.2 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100mg
Duration of treatment / exposure:
single application
Observation period (in vivo):
5 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: acoording to OECD 405

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritant / corrosive response data:
Slight to moderate chemosis and redness of the conjunctiva (individual scores of 1 or 2) were observed for 48 hours after sample introduction in 2 animals and for 72 hours in 1 animal. Iris congestion (score of 1) was noted in 1 animal after 24 hours. A slight opacity of the Cornea was noted in 2 animals after 24 hours and persisted in 1 animal after 48 and 72 hours.
Other effects:
No other effects.

Any other information on results incl. tables

Eye examinations:

Readings Animal cornea Iris conjunctiva Symptons
opacity area redness swelling discharge  
24 h 1 1 1 0 2 1 0  
2 2 2 1 2 2 1  
3 0 0 0 1 0 0  
48 h 1 0 0 0 1 0 0  
2 1 2 0 1 1 0  
3 0 0 0 1 0 0  
72 h 1 0 0 0 0 0 0  
2 1 1 0 1 1 0  
3 0 0 0 0 0 0  
5 d  1 - - - - - -  
2 0 0 0 0 0 0  
3 - - - - - -  
Mean 24 - 72 h 1 0.3 0.3 0.0 1.0 0.3 0.0  
2 1.3 1.7 0.3 1.3 1.3 0.3  
3 0.0 0.0 0.0 0.7 0.0 0.0  
Mean   0.6 0.7 0.1 1.0 0.6 0.1  

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS