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Long-term toxicity to aquatic invertebrates

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Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Justification for type of information:
There are no data information requirements for long term toxicity in aquatic invertebrates with the registered substance.
However, the available data on acute aquatic toxicity in all three trophic levels revealed that there are no effects observed in any of the tested species and under the conditions of the studies when tested up to the water solubility of the test item.
Since the test item has a very low water solubility and a logPow of 6.4 it is shown that long term effects in aquatic organisms should are be excluded for the test item.

There are no data available on long term toxicity in aquatic invertebrates with the test item. However, data with a group of structural analogue substances are available and are applied following REACH Annex XI Section 1.5 Read-Across.

Please refer to section 13 for a more detailed description of the category approach.
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: NOEC > water solubility of the test item
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2000-2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP studies performed according to OECD TG documents are used in this category approach.
Justification for type of information:
For this endpoint a read across was performed to a chemical category with a comparable phys. chem. profile and similar response in biological assays. The relevant studies were performed according to GLP and the methods applied are fully compliant with OECD TGs. A detailed read across justification is provided in chapter 13 of this dossier.
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
Principles of method if other than guideline:
none
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Category of eleven liquid crystalline compounds (please refer to chapter 13)
Analytical monitoring:
yes
Details on sampling:
depending on category compound
Details on test solutions:
According to guideline
Test organisms (species):
Daphnia magna
Details on test organisms:
According to guideline
Limit test:
no
Total exposure duration:
21 d
Hardness:
250 mg/L
Test temperature:
RT
pH:
7-8
Dissolved oxygen:
saturated solution
Nominal and measured concentrations:
depending on category compound
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: NOEC > water solubility of the test item
Details on results:
Please refer to the documentation of the read across attached.
Results with reference substance (positive control):
Please refer to the documentation of the read across attached.
Reported statistics and error estimates:
Please refer to the documentation of the read across attached.
Validity criteria fulfilled:
yes
Conclusions:
For common liquid crystalline structures a category of typical compounds was established sharing chemical structural aspects, physicochemical properties and biological responses in assays for aquatic toxicity. The query compound fulfils the category criteria for the chemical applicability domain, the physiochemical space and the biological response in the aquatic toxicity assays. In short term test in Daphnia and in long term tests in fish the query compound shows NOECs above the water solubility limit.Based on these data the category provides sufficient and reliable information to fill the data gap for the long term toxicity testing on invertebrates, i.e. Daphnia Magna Reproduction Test. In conclusion, there is sufficient and reliable evidence from the chemical category and for the test material itself to conclude that the query compound is not toxic to aquatic species in acute and in long term settings up the limit of water solubility.
Executive summary:

For eleven common liquid crystalline structures a category of typical compounds was established sharing chemical structural aspects, physicochemical properties and biological responses in assays for aquatic toxicity.

The query compound fulfils the category criteria for the chemical applicability domain, the physiochemical space and the biological response in the aquatic toxicity assays.

In short term test in Daphnia and in long term tests in fish the query compound shows NOECs above the water solubility limit.

Based on these data the category provides sufficient and reliable information to fill the data gap for the long term toxicity testing on invertebrates, i.e. Daphnia Magna Reproduction Test.

In conclusion, there is sufficient and reliable evidence from the chemical category and for the query compound itself to conclude that the test material is not toxic to aquatic species in acute and in long term settings up the limit of water solubility.

Description of key information

Long-term toxicity to aquatic invertebrates (read-across): NOEC > water solubility

Key value for chemical safety assessment

Additional information

There are no data available on long term toxicity in aquatic invertebrates with the test item. However, data with a group of structural analogue substances are available and are applied following REACH Annex XI Section 1.5 Read-Across.

All assays performed for each compound of the category clearly demonstrate the absence of any aquatic toxicological effect for this category as all EC50 values and all no effect levels

are above the water solubility limit for the respective compounds. The source compound was tested in a daphnia acute immobilisation test and in an acute toxicity assay in fish. Both studies revealed no effect levels above the water solubility limit.

Therefore, the 21-days NOEC was determined to be at least up to the solubility limit of the test substance in test water.