Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
To be conducted upon ECHA evaluation of proposal.
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 : Magnesium metaborate

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 : Only one GLP screening-study with inconclusive evidence on the test item regarding toxicity to reproduction is available. Literature search revealed no further studies for this endpoint.
- Available non-GLP studies : No non-GLP studies on the test item was available for this endpoint according to literature search.
- Historical human data : no data available.
- (Q)SAR : QSAR prediction is not valid for the magnesium metaborate (salt). In addition this endpoint cannot be well predicted via QSAR.
- In vitro methods : No acceptable in vitro methods are currently available for the endpoint developmental toxicity.
- Weight of evidence : A weight of evidence approach would not be possible as no study data is available and no reliable QSAR data was found/is not possible. A weight of evidence approach would not be conclusive for classification.
- Grouping and read-across : Read-across to other borates will always lead to an overestimation of the risk for developmental toxicity. We were unable to find a suitable analogue in order to use read-across for the endpoint developmental toxicity.
- Substance-tailored exposure driven testing [if applicable]: Not applicable.
- Approaches in addition to above: A screening study on developmental toxicity (OECD 422) revealed slight indices regarding the potential of the substance to induce developmental toxicity. These indices were not sufficient for classification, so further investigation is warranted to identify the risk.

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:
- For the tonnage band 10 -100 t/a Annex VII of the REACH Regulation is applicable. A developmental toxicity study is not mandatory, but the OECD 422 Screening study revealed indices regarding the potential of the substance to induce developmental toxicity. A sub-chronic OECD 414 study (REACH Annex IX, 8.7.2) is proposed to adequately address the respective concerns on developmental toxicity.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: unspecified

Results and discussion

Applicant's summary and conclusion