Reaction mass of 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one and 4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to fish, other

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Data of test chemical

Justification for type of information:

Data for the test chemical is from collection of data

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

WoE report is prepared based on long term toxicity to fish study:
WoE 2 and WoE 3

GLP compliance:

not specified

Analytical monitoring:

no

Vehicle:

not specified

Test organisms (species):

other: Fish

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

28 d

Reference substance (positive control):

not specified

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

0.134 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 1st study

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

0.173 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 2nd study

Validity criteria fulfilled:

not specified

Conclusions:

1. After the exposure of test chemical with fish for 28 days, NOEC was observed at 0.134 mg/l.
2. After the exposure of test chemical with fish for 28 days, NOEC was observed at 0.173 mg/l.
Thus on the basis of above available data, it can be concluded that the test chemical was toxic to fish and classified as aquatic chronic 3 as per the CLP classification criteria.

Executive summary:

Various long term studies available for the test chemical were reviewed to determine the toxic nature of test chemical on the mortality and other long term effect of fish. The studies are as mentioned below:

Based on the prediction, the long term toxicity on fish was predicted for test substance. On the basis of no effects were observed in a semi static freshwater system, the NOEC value for the test substance is estimated to be 0.134 mg/l for fish for 28 days of exposure duration. Based on this value, it can be concluded that the test chemical can be considered as toxic to fish at environmentally relevant concentrations and can be considered to be classified as aquatic chronic 3 category as per the CLP classification criteria. 

Similarly in the another study based on the prediction, the long term toxicity on fish was predicted for test substance. On the basis of no effects observed in a freshwater system, the NOEC value for the test substance is estimated to be 0.173 mg/l for fish for 28 days of exposure duration. Based on this value, it can be concluded that the test chemical can be considered as toxic to fish at environmentally relevant concentrations and chemical was readily biodegradable in water thus on that basis it can be considered to be classified as aquatic chronic 3 category as per the CLP classification criteria. 

Thus on the basis of above available data, it can be concluded that the test chemical was toxic to fish and classified as aquatic chronic 3 as per the CLP classification criteria.

Reference 2

Endpoint:

fish early-life stage toxicity

Data waiving:

other justification

Justification for data waiving:

other:

Justification for type of information:

The study is ongoing and this information will be submitted later based on ECHA communication/decision number CCH-D-2114453640-54-01/F

Description of key information

1. After the exposure of test chemical with fish for 28 days, NOEC was observed at 0.134 mg/l.

2. After the exposure of test chemical with fish for 28 days, NOEC was observed at 0.173 mg/l.

Thus on the basis of above available data, it can be concluded that the test chemical was toxic to fish and classified as aquatic chronic 3 as per the CLP classification criteria.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.134 mg/L

Additional information

Various long term studies available for the test chemical and structually and functionally similar read across chemicals were reviewed to determine the toxic nature of test chemical on the mortality and other long term effect of fish. The studies are as mentioned below:

Based on the prediction, the long term toxicity on fish was predicted for test substance. On the basis of no effects were observed in a freshwater system, the NOEC value for the test substance is estimated to be 0.134 mg/l for fish for 28 days of exposure duration. Based on this value, it can be concluded that the test chemical can be considered as toxic to fish at environmentally relevant concentrations and can be considered to be classified as aquatic chronic 3 category as per the CLP classification criteria. 

Similarly in the another study based on the prediction, the long term toxicity on fish was predicted for test substance. On the basis of no effects observed in a freshwater system, the NOEC value for the test substance is estimated to be 0.173 mg/l for fish for 28 days of exposure duration. Based on this value, it can be concluded that the test chemical can be considered as toxic to fish at environmentally relevant concentrations and chemical was readily biodegradable in water thus on that basis it can be considered to be classified as aquatic chronic 3 category as per the CLP classification criteria. 

Thus on the basis of above available data, it can be concluded that the test chemical was toxic to fish and classified as aquatic chronic 3 as per the CLP classification criteria.