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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 July to 02. September 1976
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:
1976
Report date:
1976

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
5-(benzoylamino)-4-hydroxy-3-[[1-sulpho-6-[[2-(sulphooxy)ethyl]sulphonyl]-2-naphthyl]azo]naphthalene-2,7-disulphonic acid, sodium salt
EC Number:
287-842-4
EC Name:
5-(benzoylamino)-4-hydroxy-3-[[1-sulpho-6-[[2-(sulphooxy)ethyl]sulphonyl]-2-naphthyl]azo]naphthalene-2,7-disulphonic acid, sodium salt
Cas Number:
85586-40-9
Molecular formula:
C29H19N3Na4O17S5 C29H23N3O17S5.xNa
IUPAC Name:
5-(Benzoylamino)-4-hydroxy-3-((1-sulpho-6-((2-(sulphooxy)ethyl)sulphonyl)-2-naphthyl)azo)naphthalene-2,7-disulphonic acid, sodium salt
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Remazolbrillantrot F3B AKA Muster

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
SPF Himalayan Albino Rabbits: Hoe:HIMK(SPFWiga)
Weight at study initiation: 1.5 to 2 kg
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): 100 mg
- Concentration (if solution): NA
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 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:
maximum mean total score (MMTS)
Remarks:
Maximum Average Score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 7 hours
Score:
12
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
Maximum Average Score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24 hours
Score:
5
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
Maximum Average Score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 48 h
Score:
1
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
Maximum Average Score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
110

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: not irritating