Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: data obtained after Article 25(3) request
Title:
Unnamed
Year:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Acid Black 173 - Similar Substance 01
IUPAC Name:
Acid Black 173 - Similar Substance 01
Test material form:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
HC:NZW

Test system

Amount / concentration applied:
70 mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
1
Irritation parameter:
iris score
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 1 days
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Non eye irritant
Executive summary:

Method

The substance has been tested for its skin irritation potential according to the OECD guideline 405.

Results

Non eye irritant