Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15-22 June 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in compliance with OECD Guideline 405 with deviations: temperature and humidity of animal room was not reported; animals were not observed for 21 days to study the reversibility; purity of test item not reported
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
temperature and humidity of animal room was not reported; animals were not observed for 21 days to study the reversibility; purity of test item not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): SR-365C
- Physical state: White powder
- Date received: 11 June 1993
- Storage condition of test material: Room temperature and humidity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.3 kg
- Housing: Animals were housed individually in a suspended wire cage.
- Diet: Fresh Purina Rabbit Chow (Diet #5321), ad libitum
- Water: Water, ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 h dark / 12 h light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Used as received
Duration of treatment / exposure:
No washing was done
Observation period (in vivo):
7 days (1 h after administration, Days 1, 2, 3 and 7)
Number of animals or in vitro replicates:
One female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: According to OECD Guideline 405

TOOL USED TO ASSESS SCORE: A hand held source of illumination was used to aid in scoring.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
2.3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
2.7
Max. score:
3
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
- Corneal opacity, iritis and moderate conjunctival irritation persisted through Day 7 with apparition of mis-shaped cornea and no sign of reversibility. There were no abnormal physical signs noted during the observation period.
Other effects:
None

Any other information on results incl. tables

See attached Document for Tables of Results

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, test item, SR-365C showed irreversible signs of eye irritation (mis-shaped cornea and no reversible scores within 7 days) therefore the test item is classified as “R41 Risk of serious damage to eyes”, according to the Annex VI of the Directive 67/548/EEC and ‘Category 1’ according to the CLP Regulation (EC) N° 1272-2008.
Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, one healthy female rabbit of the New Zealand White strain was exposed to 0.1 mL of undiluted test item SR-365C in their left eye while the right eye remained untreated and served as control. The eyelids were then gently held together for about one second to avoid any loss of test item. The eyes were examined and the changes were observed at 1 h and Days 1, 2, 3 and 7 after treatment and graded according to the method of OECD Guideline 405.

Corneal opacity, iritis and moderate conjunctival irritation persisted through Day 7 with apparition of mis-shaped cornea and no sign of reversibility. There were no abnormal physical signs noted during the observation period. Mean individual scores at 24, 48 and 72 h after exposure for one animal was 2.3, 1.0, 2.7 and 3.0 for cornea, iris, conjunctivae and chemosis, respectively. In this study, test item, SR-365C is considered to show irreversible signs of eye irritation on female rabbit.

Under the test conditions, test item, SR-365C showed irreversible signs of eye irritation (mis-shaped cornea and no reversible scores within 7 days) therefore the test item is classified as “R41 Risk of serious damage to eyes”, according to the Annex VI of the Directive 67/548/EEC and ‘Category 1’ according to the CLP Regulation (EC) N° 1272-2008.