Furan-2,5-dicarboxylic acid

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not relevant

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Remarks:

Preliminary waiver according to REACH regulation

Justification for type of information:

According to Column 2 of the standard data requirements for substances manufactured or imported in quantities of 10 tonnes or more of the REACH regulation, a screening study "does not have to be conducted if a pre-natal study ... is available". A test proposal to perform a pre-natal developmental study is included in the current dossier. Therefore a preliminary waiver is included in this dossier for a screening study, as from animal wellfare perspective it was considered not justified to perform this study. Once the prenatal study is available, this preliminary waiver will be updated to a final waiver.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report Date:

2018

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

This is a preliminary waiver, no testing has been performed as this was considered not ethically justified from animal wellfare perspective.

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): FDCA
- Description: White crystalline powder

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result

Dose descriptor:

NOAEL

Based on:

test mat.

Sex:

male/female

Remarks on result:

not measured/tested

Remarks:

Preliminary waiver, no test performed

Target system / organ toxicity (P0)

Key result

Critical effects observed:

not specified

Results: F1 generation

Effect levels (F1)

Key result

Dose descriptor:

NOAEL

Generation:

F1

Based on:

test mat.

Sex:

male/female

Remarks on result:

not measured/tested

Remarks:

Preliminary waiver, no test performed

Target system / organ toxicity (F1)

Key result

Critical effects observed:

not specified

Overall reproductive toxicity

Reproductive effects observed:

not specified