Reaction mass of 2-ethylhexyl (6-isocyanatohexyl)-carbamate and bis(2-ethylhexyl) 1,6-hexan-1,6-diylbiscarbamate

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

Cited as Directive 92/69/EEC, C.1

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

In the original report mistakenly the CAS number of hexamethylene diisocyanate (822-06-0) was specified. The test, however, was carried out with Desmodur LD (batch 2. filling) and the correct CAS number is 26488-60-8. The purity was not specified.

Analytical monitoring:

no

Details on sampling:

Sampling schedule:
- Control: at 96 hours
- Test concentration: at 0 and 96 hours

Vehicle:

no

Details on test solutions:

- To produce the only Water Accommodated Fraction (WAF) the test item was added to dilution water, treated with an ultra-turrax for 60 seconds and afterwards stirred for 24 h on a magnetic stirrer
- Undissolved particles were removed by filtration using a folded filter (pore size of 7-12 μm)
- pH value was measured to be 8.1.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

- Source : Bio International B.V. (Netherlands)
- Date supplied : 2000-08-28
- Holding water: synthetic freshwater according ISO standard
- Mortalities during acclimatisation period : <2 %
- Medication : none
- Mean standard length (n = 10) : 2.5 - 3.5 cm

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

No data

Test temperature:

21.5 (after 96 hrs)

pH:

7.7 (after 96 hrs)

Dissolved oxygen:

8.7 mg/L (after 96 hrs)

Salinity:

n.a.

Nominal and measured concentrations:

A Water Accommodated Fraction (WAF) was used to test effects at a limit effective loading of 100 mg/L. No specific analysis was performed.

Details on test conditions:

- Test vessels: glass aquaria (300 mm x 135 mm x 200 mm) holding 5 L of test media
- Experimental design: 1 test concentration plus 1 control
- Number of test organisms:10 fish per test concentration
- Photoperiod: 16 h light: 8 h dark
- Temperature: 21.3 - 21.5 °C
- Aeration: yes
- Test item concentration/s: 100 mg/L
- Method of administration: direct weighing
- Medium renewal: none
- Criteria of effects: The criterion of death used in this study was the absence of response to physical stimulation. In addition to observations on mortality at 2, 24, 48, 72 and 96 hours, type and incidence of sub lethal effects compared with control fish were observed.

Reference substance (positive control):

not required

Key result

Duration:

96 h

Dose descriptor:

LL0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The results are expressed in terms of Lethal Loadings (LL).

Sublethal observations / clinical signs:

A Water Accommodated Fraction (WAF) was used to test effects at a limit effective loading of 100 mg/L no specific analysis was performed.

Validity criteria fulfilled:

yes

Remarks:

mortality in the controls <10 % by the end of the test; dissolved oxygen concentration above 60 % of the air-saturation value throughout the exposure period; pH did not vary by more than 1 unit

Conclusions:

After 96 hrs a LL-50 of higher than 100 mg/L was determined. The result is expressed in terms of Lethal Loadings (LL). No toxic effects against Brachydanio rerio (scientific name: Danio rerio) were observed at a limit test concentration under exposure conditions.

Executive summary:

A study was performed to assess the acute toxicity to Brachydanio rerio (scientific name: Danio rerio) under static conditions. The study was conducted in accordance with Council Regulation (EC) No 440/2008, Method C.1 'Acute toxicity for Fish' (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992). A group of ten fish of the recommended size was exposed to a limit test concentration of nominally 100 mg/L dissolved in dilution water. Auxiliaries used to prepare the test media were an ultrasonic turrax, a magnetic stirrer and a folded filter. Observations were made on the number of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure. After 96 hrs a LL-50 of higher than 100 mg/L was measured. The result is expressed in terms of Lethal Loadings (LL). No toxic effects against Brachydanio rerio (scientific name: Danio rerio) were observed at a limit test concentration under exposure conditions.

This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute Fish study.

Description of key information

No toxic effects against fish were observed at the limit of water solubility under exposure conditions (96 h-LL0 >= 100 mg/L). The results are expressed in terms of Lethal Loadings (LL) (Caspers, 2001).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

"Should read >100 mg/L"

A Water Accommodated Fraction (WAF) was used to test effects at a limit lethal loading of 100 mg/L and no specific analysis was performed.