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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: Study conducted following the current relevant guideline and fully GLP compliant documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch number 25557

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation:17-36 weeks prior to treatment
- Weight at study initiation: 3.49-4.69 kg
- Housing: individually
- Diet: 125 g (Rabbit GD Diet Pellets) per day
- Water: ad libitum
- Acclimation period: 6 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
not specified
Controls:
other: The untreated eye was used as a comparison with the treated eye during assessment of ocular lesions
Amount / concentration applied:
55 mg
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days after treatment
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1-3
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1-3
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.7
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 1-3
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Injection of the conjunctival blood vessels was apparent in all animals during the first 24 hours after instillation, persisting in one case to the
48 hour examination; very slight discharge was evident in two animals one hour after instillation. The treated eye of each animal was overtly normal
72 hours after instillation. Instillation of the test substance gave rise to a slight or practically no initial pain response
Other effects:
There was no sign of toxicity or ill health in any rabbit during the observation period

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Instillation of VRT-126017 DCHA gave rise to a “minimally irritating” response and the test substance did not require labelling with the risk phrase
R36, “Irritating to eyes”, in accordance with Commission Directive 2001/59/EC
Executive summary:

Three rabbits were each administered a single ocular dose of a volume of 0.1 ml of the test substance

weighing approximately 55 mg and observed for four days after instillation.

Injection of the conjunctival blood vessels was apparent in all animals during the first 24 hours after

instillation, persisting in one case to the 48 hour examination; very slight discharge was evident in two

animals one hour after instillation.

The treated eye of each animal was overtly normal 72 hours after instillation.

Instillation of the test substance gave rise to a slight or practically no initial pain response.

The means of scores for the ocular reactions at approximately 24, 48 and 72 hours after

administration, calculated separately for each animal, are summarised below:

Animal number               Corneal              Iridial                        Conjunctival

opacity               lesions        Redness                 Chemosis

4982                                 0.0                    0.0                0.3                            0.0

4986                                 0.0        0.0                0.3                            0.0

4987                      0.0        0.0                0.7                            0.0