Hexamethylene diisocyanate, oligomers, reaction products with 3-methoxypropylamine

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Septeber 03, 2017 to Septeber 08, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

see 'Principles of method if other than guideline'

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

yes

Remarks:

see 'Principles of method if other than guideline'

Principles of method if other than guideline:

The following deviation from the study plan was documented:
- Temperature during husbandry was higher than stated in the guideline. As no mortality occurred during husbandry at least 12 days before the start of the test and as no mortality was observed in the control during the test this was stated as uncritical. The deviation was and assessed signed by the study director on 12. Oct. 2017.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

CAS No.: 162492-07-1; EINECS-No.: 500-740-9; Batch No.: 1591ZG-101; Purity: >98 %; Appearance: homogeneous, white powder

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Specification: Species Danio rerio HAMILTON-BUCHANAN, Age: sexually immature young fish, length: 2 +/- 1 cm, Origin: The animals were obtained from a commercial supplier. Before being used for the test, the fish were kept for 12 days under test conditions. During this period, mortality did not surpass 5 %. Supplier: Dehner Garten Center, 67433 Neustadt.

Test type:

semi-static

Water media type:

other: Good quality drinking water is used.

Remarks:

The composition is analysed yearly by the supplier.

Limit test:

no

Total exposure duration:

96 h

Hardness:

0.83 mmol/L

Test temperature:

22.9 – 23.3 °C

pH:

7.9 - 8.2

Dissolved oxygen:

7.7 - 9.0 mg/L

Conductivity:

228 μS/cm at 25 °C

Nominal and measured concentrations:

Treatment: 100 mg/L nominal concentration.
The measured concentration in the new solutions was 123.36 μg/L and 137.27 μg/L and in the old solutions 62.58 μg/L and 50.73 μg/L. Therefore, the determination of the results was based on the geometric mean of the measured concentrations.

Details on test conditions:

Medium renewal: after 48 hours
Duration: 96 hours
Loading: 1 fish/L
Vessels: glass aquaria, volume 10 L
Aeration: accomplished with glass tubes
Feeding: none
Photo period: 12/12 hours using neon tubes
Replicate (Treatments): 1 vessel, each containing 7 L test solution and 7 fish
Replicate (Blank Control): 1 vessel, containing 7 L tap water and 7 fish

Observations were made every 24 hours, meaning measuring pH and O2-concentration of the old and new test solution in each vessel and documenting mortalities or abnormal behaviour. The content of the test substance in the test vessels was measured at the beginning and at the end of the test and at medium renewal after 48 hours in the old and the new solutions. In the control the content of the test substance was measured at the beginning and at the end of the test.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: corresponding to >85.63 µg/L mean measured

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: corresponding to 85.63 µg/L mean measured

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 96 h LC50 and NOEC were determined to be > 100 and 100 mg/L, corresponding to >85.63 and 85.63 µg/L, respectively.

Executive summary:

A study was conducted to determine the toxicity of the test substance to Zebra fish (Danio rerio) according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. The study was performed using one concentration of the test substance (100 mg/L, nominal) in a semi-static design. One vessel was used for the treatment containing 7 L of test solution and 7 fish. Similarly, one vessel was used for the blank control containing 7 L of tap water and 7 fish. Observations were made every 24 h. The concentration of the substance in the vessels was measured at the beginning and at the end of the test and at medium renewal after 48 h in the old and the new solutions using HPLC. At the tested concentration, no mortality was observed. Due to poor solubility, the measured concentrations were in the low range: 123.36 and 137.27 μg/L in the new solutions, and 62.58 and 50.73 μg/L in the old solutions. Under the study conditions, the 96 h LC50 and NOEC were determined to be > 100 and 100 mg/L, corresponding to >85.63 and 85.63 µg/L, respectively (Muckle, 2017).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

85.63 µg/L

Additional information

A study was conducted to determine the toxicity of the test substance to Zebra fish (Danio rerio) according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. The study was performed using one concentration of the test substance (100 mg/L, nominal) in a semi-static design. One vessel was used for the treatment containing 7 L of test solution and 7 fish. Similarly, one vessel was used for the blank control containing 7 L of tap water and 7 fish. Observations were made every 24 h. The concentration of the substance in the vessels was measured at the beginning and at the end of the test and at medium renewal after 48 h in the old and the new solutions using HPLC. At the tested concentration, no mortality was observed. Due to poor solubility, the measured concentrations were in the low range: 123.36 and 137.27 μg/L in the new solutions, and 62.58 and 50.73 μg/L in the old solutions. Under the study conditions, the 96 h LC50 and NOEC were determined to be > 100 and 100 mg/L, corresponding to >85.63 and 85.63 µg/L, respectively (Muckle, 2017).