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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 to 28 May 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Federal Register 38, No 187
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Federal Register 38, No 187
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reactive Blue 203
IUPAC Name:
Reactive Blue 203
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test item: Reactive Blue 203

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 1.8 to 2.2 kg
- Housing: single
- Diet (e.g. ad libitum): ERKA Z-6000
- Water (e.g. ad libitum): tap water
- Acclimation period: NA


IN-LIFE DATES: From: 25. May To: 28. May 1982

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg pasted with 1 drop physiological saline solution
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test item was applied to the left eye of each rabbit. The contra-lateral eye surved as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
4
Other effects:
up to 48 h the nictitating membranes were blueish discoloured

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification according to EC: not irritating
Executive summary:

A group of 6 New Zealand White rabbit, weighing 1.8 – 2.2 kg, was used for this study.

A 100 mg portion of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls.

The eyes were examined at 1, 7, 24, 48, and 72 hours following instillation of the test material into the eyes. The readings of the eyes were made in accordance with the Draize technique for scoring ocular lesions.

No signs for eye irritating properties were observed throughout the study; up to 48 h the nictitating membranes were blueish discoloured.

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