Registration Dossier

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
Study period:
1989/10/09 - 1989/10/26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The registered substance is a UVCB material which contains substances of varying chain length. Read across was performed to an analogous material whose carbon chain length differs by an average of two CH2-groups from the registered substance. Because of the UVCB nature of these substances, the components of the registered substance were also present in the test material, albeit at slightly different concentration levels.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.32-2.74 kg
- Housing: individually house in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14-20
- Humidity (%): 52-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent eye served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Observation period (in vivo):
1h, 24h, 48h, 72h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:

The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of opacity). For each tissue the total score was calculated as follows:

Total score for conjunctivae = (A + B + C) x 2
Total score for iris = D x 5
Total score for cornea = (E x F) x 5

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information 2 A Criteria used for interpretation of results: EU
Executive summary:

The read-across from a study with an analogous substance was scientifically justified, because the analoguous substance was the disodium salt to the monosodium salt of the test substance. The chain length of the test substance differs by an average of two CH2 groups from the registered substance, but BEING AN UVCB SUBSTANCE; ALL CHEMICAL SPECIES WERE PRESENT ALSO IN THE TEST SUBSTANCE - ALTHOUGH AT SLIGHTLY DIFFERENT CONCENTRATION LEVELS.

The test substance was investigated for its eye irritation potential in accordance with OECD guideline 405 under GLP conditions. The mean scores for cornea, conjunctiva, iris effects and chemosis were 1.8, 2.9, 1 and 2.4. All effects were reversible after 14 days. Consequently the test substance is considered to be eye irritating.