Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

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:
other: Standard method but some information not reported.
Qualifier:
according to
Guideline:
other: Nichi-Nou-Sei B2735 (1965)
Principles of method if other than guideline:
(similar to OECD 203)
GLP compliance:
no
Analytical monitoring:
not specified
Details on sampling:
not reported
Vehicle:
no
Details on test solutions:
Well water with sufficient aeration.
Substance dispersed in experimental media by stirring. After addition of substance, beads form and precipitated at the bottom of experimental vessels; after 2 hours, white powder appeared on the water surface and attached to fin part of fish. After 24 hours, breads formed in media changed colour to greenish, or yellow brownish for smaller particles (reaction of substance with water).
Test organisms (species):
Oryzias latipes
Details on test organisms:
- Strain: not reported.
- Supplier: not reported.
- Age/size/weight/loading: 0.34 g; 3.2 cm in length
- Feeding: not specified.
- Pre-treatment: not reported.
- Feeding during test: No feeding during test and during the 48 hours prior to test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Remarks on exposure duration:
also 24 and 72h
Post exposure observation period:
Test parameter: mortality
Hardness:
Not reported
Test temperature:
25 ± 1ºC
pH:
pH: 7.8-8.3.
At end of test 8.2 (experimental) and 7.8 (control)
Adjustment of pH: not reported.
Dissolved oxygen:
Oxygen content: maintained through aeration. Dissolved oxygen: not reported
Salinity:
Not reported
Nominal and measured concentrations:
Concentration tested: 3000 ppm (=mg/l)
Details on test conditions:
- Renewal of test solution: each 24 hours
- Exposure vessel type: cylindrical glass vessels containing 4 L water
- Number of replicates, fish per replicate: In total 10 fish used.
- TOC: not reported
- TSS: not reported
- Conductance: not reported
- Alkalinity: not reported.
- Intensity of irradiation: not reported
- Photoperiod:12 hours
Reference substance (positive control):
not specified
Remarks:
not reported
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
> 3 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
LC0
Effect conc.:
> 3 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
> 3 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
No mortality observed.
Results with reference substance (positive control):
Number/percentage of animals showing adverse effects: 0%
Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Some details on test conditions (controls, monitoring of parameters and substance concentration in experimental media) not reported. However, since no effect were observed, results are considered informative and of interest.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
no
Analytical monitoring:
no
Details on sampling:
not reported
Vehicle:
no
Details on test solutions:
Dilution water: dechlorinated Leverkusen drinking water.
Test substance added to media and dispersed by slight stirring with a glass rod. Formation of solid droplets observed (undisolved material).
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Strain: zebra fish, Brachydanio rerio Hamilton-Buchanan from commercial hatchery (West Aquarium, Bad Lauterberg, FRG).
- Age/size/weight/loading: 30 ± 5 mm in length.
- Feeding: not specified.
- Pretreatment: 3 week acclimatisation to test laboratory conditions.
- Feeding during test: no feeding during the test.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Test parameter: perturbation ("ill") and death
Hardness:
15°dH
Test temperature:
23 ± 2 °C
pH:
pH: 6.3-7.0. Adjustment of pH: not reported.
Dissolved oxygen:
Aeration: yes
Oxygen content:> 90%
Salinity:
Not reported
Nominal and measured concentrations:
Concentrations: 500, 750, 1000 mg/l
Details on test conditions:
Exposure vessel type: 5 L tanks
Number of replicates, fish per replicate: 10 fish in each tank, two replicates with 500 mg/l, otherwise one replicate.
Intensity of irradiation: not reported.
Photoperiod: 16 hours.
TOC: not reported
TSS: not reported
Conductance: not reported
Alkalinity: not reported
Reference substance (positive control):
not specified
Remarks:
not reported
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Loading............................................Result after 96h
(mg/l)...............................................Total number of fish / ill / dead
500 ................................................... 10 / 0 / 1
750 ................................................... 10 / 0 / 0
1000 .................................................. 10 / 0 / 0

- Other effects: distinct product droplets remained in media provoking the curiosity of fish. Harmful effects on animals caused by oral ingestion or by mechanical violation of sensitive body tissues (e.g. gills) cannot be excluded.

Description of key information

A static test with zebrafish (OECD 203) indicated no mortality at 1000 mg/L after 96 hour.

Key value for chemical safety assessment

LC50 for freshwater fish:
1 000 mg/L

Additional information

The test substance is covered by the category approach of methylenediphenyl diisocyanates (MDI). Hence, data of the category substances can be used to cover this endpoint. The read-across category justification document is attached in IUCLID section 13. It is important to note that the MDI category approach for read-across of environmental and human hazards between the MDI substances belonging to the MDI category is work in progress under REACH. Therefore the read-across document should be considered a draft.

Two short-term aquatic toxicity studies are available for fish for polymeric MDI (CAS 9016-87-9). In a study with Oryzias latipes (Nakata, 1982), no acute toxicity was observed after 96h exposure to 3000 mg/L (semi-static). ). The Nichi-Nou-Sei B2735 (1965) protocol was followed, which is similar to OECD 203. A static test with Danio rerio (OECD 203) gave no mortality at 1000 mg/L, which was the highest concentration tested (Caspers, 1986). This value may be considered for the derivation of a PNECaqua. A third fish study with Danio rerio is available, but lacks some critical information. Hence it is classified as unreliable. The 24h-EC50 was determined to be > 500 mg/L. Based on the justification in the category approach of methylenediphenyl diisocyanates (MDI), it is assumed that all MDI analogues included in the category have a similar fish toxicity.