2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

experimental study planned

Study period:

2022

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Pigment Yellow 74

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: no studies available for this endpoint
- Available non-GLP studies: no studies available for this endpoint
- Historical human/control data: no data available for this endpoint
- (Q)SAR: no studies available for this endpoint
- In vitro methods: no studies available for this endpoint
- Weight of evidence: no data available for this endpoint
- Grouping and read-across:
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable] : not applicable

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 registered substance is available as a nanoform. Inhalation is, therefore, one exposure route of concern.
-There are no data available to indicate the hazards from inhalation exposure for prolonged times.
-The options for adaption provided by REACH are not applicable due to lack of information on the target substance.
-The planned study shall provide information not only for the target substance but also information useful for read across to other substances of the mono-azo-yellow pigment group.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
Details on study design / methodology proposed:
- A short-term study (28d inhalation + 56 d recovery) will be sufficient to evaluate this hazard due to the fact that the registered substance is a very poorly soluble powder and exposure will continue after inhalation for a prolonged period. Additionally, an oral 90 d study is available for the registered substance.
- Due to the fact that the test material is a very poorly soluble solid powder and a nano-material the post-exposure-recovery period will be extended to twice the exposure period to cover the possible effects of the prolonged presence of the test material at the target (lung/portal of entry).

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 412 (28-Day (Subacute) Inhalation Toxicity Study

Test material

Test material information

Constituent 1

Reference substance name:

2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide

EC Number:

228-768-4

EC Name:

2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide

Cas Number:

6358-31-2

Molecular formula:

C18H18N4O6

IUPAC Name:

2-[(2-methoxy-4-nitrophenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxobutanamide

Test material form:

solid: nanoform, no surface treatment

Test animals

Species:

rat

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: dust