Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 to 08 February 1979
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Register 38, No. 187
Principles of method if other than guideline:
Federal Register 38, No. 187
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Remazol-Brillantblau R spezial flüssig
- Substance type: preparation
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
SPF Himalayan Albino Rabbits: Hoe:HIMK(SPFWiga)
Food: ERKS 8300
Supplier: Futtermittelwerke Robert Koch oHG Hamm
Water: Tap water
Food and water ad libitum
Single housing

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
up to 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 served 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:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
28
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 7 hours
Score:
22
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
14
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 hours
Score:
8
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 hours
Score:
2
Max. score:
110
Irritant / corrosive response data:
All animals: Nictitating membranes and conjunctive bluish stained up to 24 hours
Cornea minimally bluish stained in 5 rabbits on Day 1, still visible in 3 rabbits on Day 3. Due to the short postobservation period an the fact that the staining proved already to be reversible in 2 rabbits up to the end of the observation time. Full reversibility of the staining within a 14 day post-observation time is very liely.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information 1-hour reading Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Classification according to EU: no classification necessary