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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key 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.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
Principles of method if other than guideline:
none
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
The puritiy of all compounds of the category exceeded 99.5 %.
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):category of eleven liquid crystalline compounds (cf. attachment)

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
depending on category compound

Test solutions

Details on test solutions:
According to guideline

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
According to guideline

Study design

Limit test:
no
Total exposure duration:
21 d

Test conditions

Hardness:
250 mg/L
Test temperature:
RT
pH:
7-8
Dissolved oxygen:
saturated solution
Nominal and measured concentrations:
depending on category compound

Results and discussion

Effect concentrations
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
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.

Applicant's summary and conclusion

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. Therefore the data requirement according to REACH Annex IX, 9.1.5 is fulfilled and no further experimental testing is considered justified.
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. Therefore the data requirement according to REACH Annex IX, 9.1.5 is fulfilled and no further experimental testing is considered justified.