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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
In Vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 14, 1980 - July 21, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study similar to OECD Guideline 405. QA. Environmental conditions not reported. Acceptable basic data.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
9 rabbits; exposure time
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 180-415
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- 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: Ray Nichols Rabbitry, Lumberton, Texas, USA
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually, in suspended wire bottom galvanize steel gages
- Diet (e.g. ad libitum): Purina rabbit chow, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: approx. one week

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted (100%)
Duration of treatment / exposure:
6 rabbits: 7 days (unwashed)
3 rabbits: 30 seconds (washed)
Observation period (in vivo):
1, 24, 48, and 72 hours, and at 4 and 7 days after treatment
Number of animals or in vitro replicates:
9 (6 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3 of the 9 treated rabbits washed with room temperature deionised water for 1 minute
- Time after start of exposure: 30 seconds after treatment

SCORING SYSTEM: Numerical according to guidelines described by Draize (1965) (corneal, iridic and conjunctival irritation (redness/chemosis/discharge)).

TOOL USED TO ASSESS SCORE: fluorescein: observations with fluorescein staining were made at 1 and 24 hours after the application of the test substance and until there was no staining for 3 consecutive observations.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
9 rabbits
Time point:
other: 24, 48,and 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: washed and unwashed eyes
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 24, 48, and 72 hours
Score:
ca. 0.16
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: unwashes eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 24, 48, and 72 hours
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: unwashed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24, 48, and 72 hours
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: washes eyes
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 24, 48, and 72 hours
Score:
ca. 0.16
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: unwashed eyeys
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24, 48, and 72 hours
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: washed eyes
Other effects:
None

Any other information on results incl. tables

Not relevant

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the mean scoring results (all < 1.00) and according to the criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), 180-415 does not have to be classified and has no obligatory labelling requirement for eye irritation.
Executive summary:

This eye irritation test, comparable to OECD Guideline 405, consists of a single instillation of 0.1.ml of the undiluted test material (180-415) into the conjunctival sac of the left eye of each of 9 rabbits. The treated eye was washed with water 30 seconds after exposure in 3 rabbits and the eyes were left unwashed in the remaining 6 rabbits. The untreated eye of each animal served as a negative control. The cornea, the iris, and conjunctivae were observed at 1, 24, 48, and 72 hours, and at 4 and 7 days after treatment. Observations with fluorescein staining were made at 1 and 24 hours after the application of the test substance and until there was no staining for 3 consecutive observations. The guidelines described by Draize (1965) were used to assign numerical scores to the observed effects and to develop a weighted total score for each animal for each day of observations. Based on the mean scoring results (all < 1.00) and according to the criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), 180-415 does not have to be classified and has no obligatory labelling requirement for eye irritation.