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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:
weight of evidence
Study period:
1987-05-07 to 1987-05-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
No analytical monitoring, GLP.
Justification for type of information:
Read across to the analogous substance.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Read across is based on structural and physico chemical similarity of 1,4BDDMA and 1,3-BDDMA
Common mechanism in aquatic toxicity: narcosis. No specic toxicity against aquatic organisms is expected.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Substance name 1,4-Butanediol dimethacrylate 1,3-Butanediol dimethacrylate

EC-Number 218-218-1 214-711-0
CAS-Number 2082-81-7 1189-08-8

Purity: 90-100 % Purity: 90-100 %
Reactive ester content: >= 98 % Reactive ester content: >= 98 %
1,4-Butane diol, CAS 110-63: 0-1 % 1,3-Butane diol, CAS 107-88-0 0-1 %
Methyl methacrylate, CAS 80-62-6: 0-1 % Methyl methacrylate, CAS 80-62-6 0-1 %
4-Methoxyphenol, CAS 150-76-5 0.009 – 0.011 % 4-Methoxyphenol, CAS 150-76-5 0.018 – 0.022 %


3. ANALOGUE APPROACH JUSTIFICATION
see attached document
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.