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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
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Limited observation period due to the substance being toxic through the eye (all animals died as a result of the exposure to the substance).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ranging from 2032 to 2875 g
- Diet: ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye served as the untreated control for each rabbit
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Group I (5 animals) : 5 minutes
Group II (3 animals) : 24 hours
Observation period (in vivo):
21 days (interrupted after 9 days due to the death of all animals)
Number of animals or in vitro replicates:
8 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water for 2 minutes
- Time after start of exposure: 5 minutes (Group I) or 24 hours (Group II)

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Observation of animals exposed to the substance for 5 minutes
Basis:
mean
Remarks on result:
other: Extreme irritant and probable corrosive substance
Irritation parameter:
other: Observation of animals exposed to the substance for 24 hours
Basis:
mean
Remarks on result:
other: Extreme irritant and probable corrosive substance
Irritant / corrosive response data:
Extreme irritant following a 5 minute or 24 hour exposure to the substance. The death of all animals prevented from assessing the reversibility of the effects after 21 days of observation but it was concluded by the authors of the study that the substance was probably corrosive.
Other effects:
All animals died by the 9th day of the observation period.

Any other information on results incl. tables

see attached background document

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance was found to be an extreme eye irritant and a probable corrosive substance (the irriversibility of the effects could not be assessed due to the death of the animals). Considering this result and the classification of the substance as Skin Corr. 1B; H314, it should be classified as Eye Dam 1. H318 according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

In addition, based on mortality which occurred in this study, the sentence ‘EUH070 - Toxic through eye’ is applicable according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Executive summary:

An in vivo eye irritation study was performed according to a method similar to the OECD Testing Guideline 405 (non-GLP) with deviations. The study was interrupted before the end of the observation period of 21 days due to the death of all the animals, but it is considered as providing sufficient information to conclude regarding the potential of the substance to cause eye damage.

Five New Zealand rabbits (Group I) and three New Zealand rabbits (Group II) received 0.1 ml of undiluted substance in the right eye and were exposed for 5 minutes or 24 hours respectively before removal of the substance by gentle washing. The effects to the eye in the animals were scored according to Draize.

The substance was found to be an extreme eye irritant and a probable corrosive substance (the irreversibility of the effects could not be assessed due to the death of the animals). Considering this result and the classification of the substance as Skin Corr. 1B; H314, it should be classified as Eye Dam 1. H318 according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

In addition, based on mortality which occurred in this study, the sentence ‘EUH070 - Toxic through eye’ is applicable according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.