Mercaptoacetic acid

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

Study period:

2 years from ECHA's approval (final decision on TP)

Justification for type of information:

Since mercaptoacetic acid is not P, not vP, not B and not vB, no further analysis of the T property is needed in the framework of the PBT/vPvB classification. OECD 210 is not needed for T assesment. It is laid down in the REACh Regulation EC 1907/2006 Annexes IX, section 9.1.6, column 2, that long-term fish toxicity testing shall be proposed by the registrant if the chemical safety assessment (CSA) indicates such a need. Since the CSA indicates that both freshwater and marine water RCRs are all inferior to 1, no further aquatic toxicity testing is needed.

Furthermore, as indicated in the final decision number CCH-D-2114541355-52-01/F, the OECD 210 is required only if the RCR >1. In our dossier the RCR are below 1, so no further study is needed.

However, in accordance with the Decision of the Board of Appeal in case A-011-2018, the REACh Annex IX, Section 9.1., Column 2 does not allow omitting the need to submit information on long-term toxicity to fish under Column 1. Therefore, fish long-term toxicity testing is a standard information requirement under annex IX of REACh regulation EC 1907/2006. Therefore, an OECD 210 study is proposed and cannot be waived.


CONSIDERATIONS OF ALTERNATIVE METHODS ON TESTING PROPOSALS IN YOUR REGISTRATION

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Public substance name: Thioglycolic Acid
EC Number (omit if confidential): 200-677-4
CAS Number (omit if confidential): 68-11-1

Date of considerations: 02 November 2022.


• Hazard endpoint for which vertebrate testing was proposed:

Fish early-life stage toxicity study with Thioglycolic Acid (EC Number 200-677-4, CAS Number 68-11-1) according to the OECD Test Guideline 210.


• Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information (instruction: please address all points below):

• available GLP studies
None
• available non-GLP studies
None
• historical human data
Not relevant
• (Q)SAR
To our knowledge, there is no appropriate QSAR for estimating chronic toxicity with same endpoints as the OECD TG 210.
• in vitro methods
To our knowledge, there is no validated in vitro test method for estimating chronic toxicity with same endpoints as the OECD TG 210.
• weight of evidence
There are not enough available data for a weight of evidence approach.
• grouping and read-across
There are no identified groups of substances or similar substances for a read across approach.

• Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable:

No datum for long-term toxicity to fish is available for the registered substance. In accordance with the Decision of the Board of Appeal in case A-011-2018, the REACh Annex IX, Section 9.1., Column 2 does not allow omitting the need to submit information on long-term toxicity to fish under Column 1. Therefore, fish long-term toxicity testing is a standard information requirement under annex IX of REACh regulation EC 1907/2006. Therefore, an OECD 210 study is proposed and cannot be waived.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

Test material information

Constituent 1

Reference substance name:

Mercaptoacetic acid

EC Number:

200-677-4

EC Name:

Mercaptoacetic acid

Cas Number:

68-11-1

Molecular formula:

C2H4O2S

IUPAC Name:

2-sulfanylacetic acid