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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: similiar to OECD guideline (instillation of only 50 mg , not 100 mg), no GLP

Data source

Reference
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ETAD-Subkomitee für Toxikologie: Empfohlenen Methoden zur toxikologischen Untersuchung von Farbstoffen und Hilfsmitteln
Principles of method if other than guideline:
Method: application of test substance into the conjunctival sac of one eye of each of 2 rabbits, .Observation period was 7 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
EC Number:
291-454-0
EC Name:
Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
Cas Number:
90411-76-0
Molecular formula:
Mixture of components, no definitve molecular formula existing.
IUPAC Name:
Complex mixture of phenazine dyes - IUPAC name not available
Test material form:
other: solid
Details on test material:
IUCLID4 Test substance::
commercial formulation, purity ca. 99%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
body weight at the start of the study: 3-4 kg
one male and one female rabbit
housing individually
diet ad libitum
water ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye served as contol
Amount / concentration applied:
50 mg/animal
Duration of treatment / exposure:
no data
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
Method: application of test substance into the conjunctival sac of one eye of each of 2 rabbits, .Observation period was 7 days., the opposite eye served as control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal:
Time point:
other: up to 7 days
Score:
ca. 0
Max. score:
110
Remarks on result:
other: no irritation was observed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
no reactions were observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Application of 50 mg and not 100 mg test substance into the conjunctival sac of one eye of each of 2 rabbits; the untreated other eye served as control Observation period was 7 days. No reaction of the eyes were observed. Therefore, Nigrosin WLF has to be evaluated as non-irritating to the mucous membranes.