N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

sub-chronic toxicity: inhalation

Type of information:

experimental study planned

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS
The test material is an insoluble nanomaterial. Inhalation is, therefore, the most relevant route of exposure.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 3-hydroxy-4-{[2-methoxy-5-(phenylcarbamoyl)phenyl]diazenyl}-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)-2-naphthamide

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: none
- Available non-GLP studies: none
- Historical human/control data: none
- (Q)SAR: no validated QSAR method is available for the repeated dose toxicity endpoint
- In vitro methods: no validated in vitro method is available for the repeated dose toxicity endpoint
- Weight of evidence: only results from shorter oral repeated dose study available, insufficient to conclude on the endpoint in a weight of evidence approach.
- Grouping and read-across: this substance is part of a read-across approach. No 90d repeated dose toxicity studies are available for any of the members of the read-accross group. Data generated on the current substance will be used as read-across source to the 4 other pigments in the read-across group.
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable]: none
- Other reasons [if applicable]: no

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The substance does not exert severe toxicity in the available repeated dose toxicity test. No chronic studies are available and immediate disintegration of the test item does not occur. The substance is of low toxicological activity, with no toxicological effects observed in any of the available studies. However, the absence of significant human exposure cannot be substantiated as no exposure assessment has been performed.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: no further information relevant.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 413 (90-Day (Subchronic) Inhalation Toxicity Study

Test material

Test material information

1

Reference substance name:

N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide

EC Number:

235-425-2

EC Name:

N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide

Cas Number:

12225-06-8

Molecular formula:

C32H24N6O5

IUPAC Name:

3-hydroxy-4-{[2-methoxy-5-(phenylcarbamoyl)phenyl]diazenyl}-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)-2-naphthamide

Test material form:

solid: nanoform, no surface treatment

Test animals

Species:

rat