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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1987-05-07 to 1987-05-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation; no analytical monitoring, GLP.
Justification for type of information:
Read across to the analogous substance.
REPORTING FORMAT FOR THE ANALOGUE APPROACH
see attached category document

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
see attached category document, chapter 1.1ff

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see attached category document, chapter 1

3. ANALOGUE APPROACH JUSTIFICATION
see attached category document, chapter 5 (Toxikokinetics) and endpoint specific chapters

4. DATA MATRIX
see attached category document, table in chapter 1.2 and endpoint specific chapters
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: DIN 38412 part 15
Deviations:
yes
Remarks:
only 48 h exposure instead of 96 h
GLP compliance:
yes
Analytical monitoring:
not specified
Details on sampling:
no data
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Marlowet EF
Test organisms (species):
other: Idus melanotus HECKEL; also: Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: golden orfe
- Strain: Idus melanotus HECKEL
- Source: Fa. Eggers
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): no data
- Weight at study initiation (mean and range, SD): no data
- Method of breeding: no data
- Feeding during test
- Food type: Tetramin
- Amount: no data
- Frequency: no data
- Other: medication: Zephirol 1:50000

ACCLIMATION
- no data
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
no
Hardness:
ca. 15°d
Test temperature:
20 ± 1°C
pH:
7.7
Dissolved oxygen:
no data
Salinity:
no data
Nominal and measured concentrations:
nominal: 25, 30, 40 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 18 L glass aquaria with 10 L fill volume
- Aeration: no data
- Type of flow-through (e.g. peristaltic or proportional diluter): no data
- Renewal rate of test solution (frequency/flow rate): no data
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): no data
- No. of vessels per vehicle control (replicates): no data
- Biomass loading rate: no data

TEST MEDIUM / WATER PARAMETERS
No data

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: 16 h light/8 h dark
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- 25, 30, 40 mg/L
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
32.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
not specified
Remarks on result:
other: 23.2 - 45.5 mg/L
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
25 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
not specified
Details on results:
no further observations reported
Results with reference substance (positive control):
no reference substance
Validity criteria fulfilled:
not specified
Conclusions:
The 48-h EC50 of 1,3-BDDMA in golden orfes (Idus melanotus HECKEL) was 32.5 mg/L. The 48-h NOEC was 25 mg/L.
Executive summary:

No study of aquatic toxicity to fish is available with 1,4 -BDDMA. Acute aquatic toxicity to fish was assesed based on read across with an acute toxicity study of 1,3 -BDDMA.

In a 48-h acute toxicity study according to DIN 38412 part 15, golden orfes (Idus melanotus HECKEL) were exposed to 1,3-BDDMA nominal concentrations of 25, 30 and 40 mg/L under static conditions. 

The 48-h EC50 was 32.5 mg/L. The 48-h NOEC was 25 mg/L. 

 

A classification of 1,3-BDDMA in this study is not possible due to shortened exposure duration (48 h instead of 96 h as recommended in current guidelines). 

 

Results Synopsis

 

Test organism size/age (mean wet weight or length): no data

Test Type: Static

 

EC50:  32.5 mg/L                         95% C.I.:  23.2 to 45.5 mg/L

NOEL:  25 mg/L                            

Description of key information

One acute freshwater study in fish is available for the structural analogue 1,3-BDDMA, which is considered reliable with restriction (Klimisch score 2). In a 48-h acute toxicity study according to DIN 38412 part 15, golden orfes (Idus melanotus ) were exposed to 1,3-BDDMA nominal concentrations of 25, 30 and 40 mg/L under static conditions. The 48-h EC50 was 32.5 mg/L. The 48-h NOEC was 25 mg/L. 

A QSAR predictidion was performed with 1,4-BDDMA. LC50 96h fish of 1,4-Butanediol dimethacrylate predicted from category trend analysis of 15 methacrylates is 12.4 mg/l. This prediction confirms the less detailed documented study with 1,3-BDDMA (LD50 fish, only 48h exposure).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
32.5 mg/L

Additional information

One acute freshwater study in fish is available for the structural analogue 1,3-BDDMA, which is considered reliable with restriction (Klimisch score 2). In a 48-h acute toxicity study according to DIN 38412 part 15, golden orfes (Idus melanotus ) were exposed to 1,3-BDDMA nominal concentrations of 25, 30 and 40 mg/L under static conditions. The 48-h EC50 was 32.5 mg/L. The 48-h NOEC was 25 mg/L. 

A QSAR predictidion was performed with 1,4-BDDMA. LC50 96h fish of 1,4-Butanediol dimethacrylate predicted from category trend analysis of 15 methacrylates is 12.4 mg/l. This prediction confirms the less detailed documented study with 1,3-BDDMA.