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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
11 Jan - 11 Mar 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: M.A.F.F. No. 4200 (1985)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: white powder
- Analytical purity: considered as 100 % for the study
- Batch no.: 21150
- Storage conditions: at room temperature
- Expiry date: 2000-08-01
- Other: pH = 5.8;
- Other: volumetric mass = 0.54 g/mL

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chalaronne, France
- Age at study initiation: about 3 months
- Weight at study initiation: 2.38-2.66 kg
- Housing: barrier protected unit, individually in stainless steel cages
- Diet: about 150 g/animal/day pelleted complete rabbit diet 112 C-10 (Usine d'Alimentation Rationnelle, Epinay-sur-Orge, France)
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3
- Humidity (%): > 45%
- Air changes (per hr): min. 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 Jan 1999 To: 28 Jan 1999

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL (54 mg)
The test substance was crushed to a fine powder for eye treatment.
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0.11
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Slight to moderate effects on the conjunctivae (redness and chemosis) and slight effects on the iris (congestion) were observed in all animals 1 h after test substance instillation. In a single animal, effects on the iris persisted up to 48 h and reversed thereafter. No effects on cornea were observed in any animal tested.
Other effects:
No further local or systemic effects were observed.

Any other information on results incl. tables

Table 1. Results of eye irritation study

Rabbit #

Time [h]

conjunctivae

 

iris

cornea

redness

chemosis

1

1

1

1

1 l

0 h

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

2

1

1

0

1 c

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

3

1

2

1

1 c

0

24

0

0

1 l

0

48

0

0

1 l

0

72

0

0

0

0

average

0

0

0.67

0

4

1

2

1

1 l

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

5

1

2

2

1 l

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

6

1

1

1

1 l

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0

0

0

0

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

average
score

1

1.50

1.00

1

0

24

0.00

0.00

0

0

48

0

0

0

0

72

0

0

0

0

24+48+72

0

0

0.11

0

h = slight adherence of the test article to the corneal surface; c = circumcorneal injections + congestions of the iris; l = circumcorneal injections

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified