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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:
21 Sep - 2 Nov 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: aqueous solution

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino - Littlerussian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: DIMED Schonwalde GmbH, Schonwalde
- Age at study initiation: approx. 6-7 months
- Weight at study initiation: 2.4-2.6 kg
- Housing: During a pre-period of at least one week and throughout the study the rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet: A pelleted complete rabbit diet "Altromin 2123" was available, ad libitum.
- Water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
water
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 30% (v/v)

Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h and 7, 14 and 21 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE:
Initial test:
The treated eye was examined and the grade of ocular reaction was recorded 1 h and 24 h later. After the 24 h-reading Fluorescein was instilled. After irrigation with 20 mL 0.9 % sodium chloride solution the eye was examined again using UV light to detect possible corneal damage. The eye was also examined 48 h and 72 h after the treatment as well as on day 7 and 14.

Confirmatory Test:
During the confirmatory test the eyes of the animals were likewise examined for ocular reactions 1 h, 24 h, 48 h and 72 h after the application as well as on Day 7, 14 and 21.




Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Table 1. Results of eye irritation study.

Rabbit #

Time [h]

conjunctivae

 

iris

cornea

 

conjunctivae

 

iris

cornea

redness

swelling

redness

swelling

 

 

1

1 h

3

2

0

1

 

24 h

2

2

1

1

48 h

2

1

1

1

72 h

2

1

1

1

average

2.0

1.3

1.0

1.0

Time to reversion

14

7

7

14

2

1 h

2

1

1

1

 

 

24 h

2

2

1

2

48 h

2

1

1

1

72 h

2

1

1

1

average

2.0

1.3

1.0

1.3

Time to reversion

14

7

7

21

3

1 h

2

1

0

1

 

 

24 h

2

2

1

1

48 h

2

2

1

1

72 h

2

1

1

1

average

2.0

1.7

1.0

1.0

Time to reversion

14

7

7

7

 

 

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

avg. time to reversion [Days]

14

7

7

14

average
score

1

2.33

1.33

0.33

1.00

 

24

2.00

2.00

1.00

1.33

48

1.67

1.33

1.00

1.00

72

1.67

1.00

1.00

1.00

24+48+72

1.78

1.44

1.00

1.00

Applicant's summary and conclusion

Interpretation of results:
other: Eye irritation 2, H319. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS).
Conclusions:
CLP: Eye irrit 2, H319
Executive summary: