Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Study period:
14 Jan- 18 Jan 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
no
Analytical monitoring:
yes
Details on sampling:
- Concentrations: only 1000 mg/L was measured
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION- Method: Direct weight of the test substance in the test vessels. Ultrasonic treatment (5 min) and warming to 40°C to enable solution of the water insoluble test substance.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM- Common name: Zebra fish- Source: Company "Westaquarium"ACCLIMATION- Acclimation period: > 1 week- Type and amount of food: Altromin 1314, A1410, identical with 1413, but pelleted instead of grated- Health during acclimation (any mortality observed): <0.1% one week prior to testing
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
approx. 250 mg CaCO3/L
Test temperature:
22.5-23.5 °C
pH:
Test begin: 8.2Test end. 8.0-8.1
Dissolved oxygen:
Test begin: 94-97 %Test end: 75-77% (only at 3000 mg/L TS - highest concentration - 52%)
Nominal and measured concentrations:
Nominal: 0, 100, 300, 1000 and 3000 mg/LMeasured (1000 mg/L): 507 and 524 mg/L at 0 hours and 549 and 515 mg/L at 24 hours
Details on test conditions:
TEST SYSTEMTEST SYSTEM- Test vessel: 10 L aquaria, 5 L test water- Renewal rate of test solution (frequency/flow rate): every 24 hoursTEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: standard dilution waterOTHER TEST CONDITIONS- Photoperiod: about 16 h illumination per dayEFFECT PARAMETERS MEASURED : mortalityTEST CONCENTRATIONS- Spacing factor for test concentrations: beginning at 100 mg/L, factor 3
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
550 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
300 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- The test substance is hardly soluble in water and it is only possible to create an emulsion for a certain time. Therefore, the LC50 values refer to the total nominal concentrations- Behavioural abnormalities: none
Reported statistics and error estimates:
The LC50 was determined according to Stephan (square root of LC0 times LC100 value)
Sublethal observations / clinical signs:

Table 1: Mortality [%] of Danio rerio after 6, 24, 48, 72 and 96 hours test duration

 

Test duration (h)

in mg/L

0

6

24

48

72

96

0

0

0

0

0

0

0

100

0

0

0

0

0

0

300

0

0

0

0

0

0

1000

0

0

0

100

100

100

3000

0

0

40

100

100

100

Validity criteria fulfilled:
yes
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
09 - 11 Mar 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
only 48 h-study
Qualifier:
according to guideline
Guideline:
other: DIN 38412/15, German standard method for the examination of water, waste water and sludge, Bioassays (group L), Determination of the effect of substances in water on fish; fish test L15
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Method: Direct weight of TS into test vessels, filled up to 10 L volume, stirred with ultraturrax for 5 minutes
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM- Common name: Golden orfe- Length at study initiation: approx. 6 cm
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
approx. 16 °dH (93 mg Ca/L and 12 mg Mg/L)
Test temperature:
20-21°C
pH:
7.7-8.2
Dissolved oxygen:
48 to 100%
Salinity:
no data
Nominal and measured concentrations:
Nominal: 0, 1, 10, 100, 1000, 3000 and 10000 mg/L
Details on test conditions:
TEST SYSTEM- Test vessel: 10 L glass aquaria- No. of organisms per vessel: 10- No. of vessels per concentration (replicates): 1- No. of vessels per control (replicates): 1TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: Copper- and chlorine free tap waterOTHER TEST CONDITIONS- Photoperiod: 16 hours light, 8 hours darkness per dayEFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality at 0, 6, 24 and 48 hours
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
5 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
3 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: none
Sublethal observations / clinical signs:

Table 1: Mortality in % of Leuciscus idus after 24 and 48 h incubation time

Concentration

Incubation time (in h)

in mg/L

0

24

48

1

0

0

0

10

0

0

0

100

0

0

0

1000

0

0

0

3000

0

0

0

10000

0

100

100

Validity criteria fulfilled:
yes

Description of key information

No effects up to the limit of water solubility

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
550 mg/L

Additional information

No experimental data evaluating the acute toxicity of methyl ricinoleate (CAS No. 141-24-2) to fish are available. Therefore, toxicity data from two structurally similar methyl esters, methyl palmitate (CAS No. 112-39-0) and Fatty acids, C16-18 and C18 unsaturated, methyl esters (CAS No. 67762-38-3) are used to assess the toxicity to fish in a read across approach.

The key study investigated the acute toxicity of methyl palmitate (CAS 112-39-0) to fish (BASF, 2001). The test was conducted according to ISO Guideline 7346-1. Danio rerio was exposed to the test substance for 96 h within a semi-static water regime, at nominal concentrations ranging from 100 to 3000 mg/L. After the exposure period, 100% mortality was observed at the highest concentrations tested (1000 and 3000 mg/L), whereas no effects were reported in any other group and therefore, the LC50 (96 h) was determined to be 550 mg/L (nominal concentrations). Nevertheless, methyl palmitate is highly insoluble in water (water solubility 0.004 mg/L) and thus, the observed effects are expected to be rather physical than associated to toxicity of the substance. Test solutions were prepared by direct addition of the substance in the vessels, followed by an ultrasonic treatment but no filtration was performed. Undissolved test material in the bottom of the test vessels and an oily film floating in the surface were observed in the test solution, probably causing the observed effects (e.g. by clogging of fish gills).

The supporting study with Fatty acids, C16-18 and C18 unsaturated, methyl esters (CAS 67762-38-3) was conducted according to the German Guideline DIN 38412/15 (BASF, 2001). Leuciscus idus was exposed for 48 h to the test substance within a static water regime, at nominal concentrations ranging from 1 to 10,000 mg/L. After the exposure period, no effects on fish survival were reported at any of the concentrations tested except for the highest (10,000 mg/L, nominal), at which 100% mortality occurred (LC50 (48 h) = 5500 mg/L, nominal). Once again, since the water solubility of the test substance is < 0.05 mg/L and the solution was prepared by direct addition and no filtering step, the observed effects are most likely caused by physical interference with undissolved test substance rather than due to toxicity.

Based on the results obtained for structurally similar methyl esters methyl ricinoleate (CAS 141-24-2) is not expected to show acute toxicity to fish species up to the limit of its water solubility.