Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, basic data given

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Consumer Product Safety Commission, USA; Code of Federal Regulations, Title 16, Section 1500.42
Principles of method if other than guideline:
The method used is similar to the OECD test guideline 405 (Acute Eye Irritation/Corrosion) with some deviations (first observation 24 h after application, differing scoring system, limited reporting)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Produkt 104.111
- Physical state: white powder
- Melting point: ~ 79.5 °C
- Analytical purity: no data
- Storage condition of test material: room temperature
- Fraction in Naphthalene oil: > 35 %

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbits
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: second eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Draize (ETAD recommendation)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 h
Score:
2.67
Max. score:
110
Reversibility:
fully reversible within: 3 days
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 h
Score:
2.17
Max. score:
110
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: day 1, 2, and 3
Score:
0.056
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: day 1, 2, and 3
Score:
0.389
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: day 1, 2, and 3
Score:
0.111
Max. score:
4
Reversibility:
fully reversible within: 2 days

Any other information on results incl. tables

Individual scores (according to Draize)

 

 

Rabbit 1

Rabbit 2

Rabbit 3

Rabbit 4

Rabbit 5

Rabbit 6

Observation time (day)

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

Cornea

Opacity

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Area

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Iris

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae

Redness

1

1

0

0

1

0

0

0

1

0

0

0

1

1

0

0

1

0

0

0

0

0

0

0

Chemosis

1

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Discharge

0

0

0

0

0

1

0

0

0

0

0

0

0

1

0

0

1

0

0

0

0

0

0

0

 

 

Total score (according to Draize, summation over all rabbits)

 

Day

1

2

3

7

Total score

16

13

0

0

Following instillation of the test compound, none of the test animals showed any reaction of the cornea. An iris reaction was only seen in one rabbit at day 2 (grade 1). Conjunctiva redness grade 1 was observed in 5 rabbits over a period of maximal two days and slight chemosis (grade 1) was noted in one rabbit at day 1. All effects had subsided at day 3.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Eye reactions were minor and could only be noted at day 1 and 2 of the observation period (iris reaction, conjunctivae redness, and chemosis, score 1 or 2). Effects had disappeared at day 3. Cut-off scores for classification as irritating to the eye according to EU regulations have not been exceeded.