Tetramethylene dimethacrylate

Short-term toxicity to fish

Link to relevant study record(s)

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.