Registration Dossier

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:
1982-11-09 to 1982-11-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal, Germany
- Weight at study initiation: average weight of 2.5 kg
- Housing: individually in cages
- Diet (e.g. ad libitum): diet “mümmel z" (ssniff / Soest); ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- 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): 0.1 mL
Duration of treatment / exposure:
single treatment, the treated eye was not washed
Observation period (in vivo):
Scoring was conducted after 1, 24, 48, 72 hours and 8 days after treatment
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Draize (see Table 1 in box "Any other information on materials and methods incl. tables")

TOOL USED TO ASSESS SCORE: ophthalmoscope, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.56
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.22
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
All symptoms were fully reversible within 8 days. For individual results see Table 2 in box "Any other information on results incl. tables". In 2 of 3 animals a positive response of conjunctival redness is ≥ 2 which leads to a classification of Eye Irrit. (Cat. 2) according to CLP criteria.

Any other information on results incl. tables

Table 2: Individual Eye Irritation Scores

24 hours 48 hours 72 hours 8 days Mean (24,48 and 72 hours)
Animal no. Cornea Iris Conjunctivae Chemosis Cornea Iris Conjunctivae Chemosis Cornea Iris Conjunctivae Chemosis Cornea Iris Conjunctivae Chemosis Cornea Iris Conjunctivae Chemosis
1 1 1 3 2 1 1 3 2 1 0 2 1 0 0 0 0 1 0,67 2,67 1,67
2 1 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0,3 0 0,3 0,3
3 1 0 2 1 0 0 2 1 0 0 2 1 0 0 0 0 0,3 0 2

1

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In an acute eye irritation/corrosion study in rabbits 2 of 3 animals showed irritanting effects on the conjunctivae, which were fully reversible within 8 days.
Executive summary:

In a primary eye irritation study (OECD 405), 0.1 mL of the test item was instilled into the conjunctival sac of the right eye of three young adult New Zealand White rabbits. Animals then were observed for 8 days. Irritation was scored by the method of Draize. In 2 of 3 animals, the irritation score of conjunctivae redness was ≥ 2. Irritation on cornea and conjunctivae chemosis have been also observed. All symptoms were fully reversible within 8 days. In this study, the test item is an eye irritant and according to CLP criteria classification as Eye Irrit. 2 (H319) is warranted.