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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
no
Remarks:
At the time of the study conduct, GLP was not compulsory. However, the study was conducted in accordance with the principles of GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: 20% of the pure active substance in water
Details on test material:
- Name of test material: DOPA-Glycinate


Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Rabbit farm, Bremervörde, Germany
- Weight at study initiation: 2.4–2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): pelleted rabbit diet, ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: at least 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±2
- Humidity (%): 50-85
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated right eyes served as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Group 1: Animal 1–3; no removal of test substance
Group2: Animal 4–6 exposure for 4 sec.
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed out with 10 mL lukewarm water (animal 4–6).
- Time after start of exposure: 4 sec

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1-6
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1-6
Time point:
other: mean 24, 48, 72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: reversibility cannot be judged as the observation was not continued after the 72 h time point
Irritation parameter:
conjunctivae score
Basis:
animal: 1-6
Time point:
other: mean 24, 48, 72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: reversibility cannot be judged as the observation was not continued after the 72 h time point
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: reversibility cannot be judged as the observation was not continued after the 72 h time point
Irritation parameter:
chemosis score
Basis:
animal: 2-5
Time point:
other: mean 24, 48, 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: reversibility cannot be judged as the observation was not continued after the 72 h time point
Irritant / corrosive response data:
Reversibility of the eye reactions could not be observed within the 72 hour-study period. All animals showed absence of the light reflex (iridial response grade 2) which persisted for 72 hours. According to the guidelines, this lesion is generally not reversible.


Any other information on results incl. tables

Table A6.1.4 -4:Acute eye irritation in rabbits of group 1 (no removal of test substance).

 

Cornea

Iris

Conjunctiva

Score (animal #1, #2, #3)

Opacity

 

Redness

Chemosis

1 h

0/0/0

2/2/2

3/3/3

3/4/4

24 h

0/0/0

2/2/2

3/3/3

3/4/4

48 h

0/0/0

2/2/2

3/3/3

3/4/4

72 h

0/0/0

2/2/2

3/3/3

3/4/4

Average 24, 48, 72 h

0/0/0

2/2/2

3/3/3

3/4/4

 

Table A6.1.4 -5:Acute eye irritation in rabbits of group 2 (removal of test substance).

 

Cornea

Iris

Conjunctiva

Score (animal #4/#5/#6)

Opacity

 

Redness

Chemosis

1 h

0/0/0

2/2/2

2/3/3

3/4/4

24 h

0/0/0

2/2/2

3/3/3

4/4/4

48 h

0/0/0

2/2/2

3/3/3

4/4/4

72 h

0/0/0

2/2/2

3/3/3

4/4/4

Average 24, 48, 72 h

0/0/0

2/2/2

3/3/3

4/4/4

 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
In this eye irritation test in rabbit, DOPA-Glycinate (20% a.i.) caused diffuse beefy redness and swelling with lids about half closed or more than half closed (grade 3) as well as lesions of the iris grade 2. Thus, the test substance has to be classified as Category 1 (irreversible effects on the eye).
Executive summary:

The acute eye irritation of DOPA-Glycinate (20% aqueous solution, “product by process”) was tested in New Zealand White rabbits, according to EC method B.5 (1984) and OECD guideline 405 (1981). Six rabbits were administered a dose of 0.1 mL test substance into the left eye. In one group consisting of three animals the eyes were not washed, while in the other group the test substance was removed after 4 seconds.

The results with and without removal of the test substance were consistent. No corneal opacity was observed during the study. Diffuse beefy redness and swelling with lids about half closed or more than half closed as well as lesions of the iris grade 2 (no reaction to light, haemorrhage and/or gross destruction) were observed throughout the study period. Reversibility was not observed within the observation period of 72 hours. According to the guidelines, absence of the light reflex (iridial response grade 2) which persists for 72 hours is generally not reversible.

Thus, according to the requirements specified Regulation (EC) 1272/2008 and subsequent regulations, DOPA-Glycinate (20% a.i.) requires classification as Category 1 (irreversible effects on the eye).