Registration Dossier

Toxicological information

Toxicity to reproduction

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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

Applicant's summary and conclusion