Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study planned
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: Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: none
- Available non-GLP studies: none
- Historical human/control data: none
- (Q)SAR: QSAR predictions for relevant constituents of the UVCB substance can rather be used as supporting information or as part of a weight-of-evidence approach
- In vitro methods: not applicable
- Weight of evidence: no long-term data or other information available
- Grouping and read-across: not applicable
- Substance-tailored exposure driven testing [if applicable]: n/a
- Approaches in addition to above [if applicable]: n/a
- Other reasons [if applicable]: n/a

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:
- According to REACH Annex IX, section 9.1, Column 2, appropriate long-term toxicity testing on aquatic invertebrates shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms.
However, Board of Appeal decision on case A-011-2018 overrides advice given in the ECHA Guidance; as a result information on aquatic toxicity described in ECHA’s Guidance on Information Requirements and Chemical Safety Assessment related to REACH Annex IX, section 9.1, Column 2 as a waiver for the information requirement under Column 1 is no longer valid.
The testing sequence for a conclusion on T based on chronic ecotoxicity data is Daphnia and then fish according to ECHA Guidance on information requirements and chemical safety assessment (version 4.0, June 2017), Chapter R7b. Therefore, the performance of a chronic Daphnia study according to OECD 211 is proposed.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: The most meaningful study design will be elaborated with the study director of the appointed test facility based on the behaviour of the test item in the respective test medium and the results of related pre-experiments.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)

Test material

Constituent 1
Chemical structure
Reference substance name:
Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane
Cas Number:
68413-24-1
Molecular formula:
C24H36O2
IUPAC Name:
Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): CARDOLITE NC-513
- Physical state: liquid
- Storage condition of test material: room temperature 20 ± 5 °C, keep away from humidity

Results and discussion

Applicant's summary and conclusion