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Ecotoxicological information

Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods and conducted under GLPs.
Qualifier:
according to guideline
Guideline:
other: DIN 38412 Teil 15; Part 1
Principles of method if other than guideline:
Method: other: DIN 38412 Teil 15; Part 1
GLP compliance:
yes
Analytical monitoring:
no
Details on sampling:
Not applicable
Vehicle:
no
Details on test solutions:
No data
Test organisms (species):
Leuciscus idus melanotus
Details on test organisms:
TEST ORGANISM
- Common name: golden orfe
- Source: Fa. Eggert
- Food type: Tetramin


Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
20 +/- 1 °C
pH:
7.7
Nominal and measured concentrations:
400, 500, and 600 mg/L nominal reported.
Details on test conditions:
TEST SYSTEM
- Test vessel: 18 l glass aquaria
-Test volume: 10 l
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 0

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Drinking water, dechlorinated
- Medikation: Zephirol 1:50 000

OTHER TEST CONDITIONS
- Photoperiod: 16 h light, 8 h dark

Reference substance (positive control):
not specified
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
379 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: EC50: 236-1033 mg/l (95%CL)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
493 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
641 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
10, 20 ,and 100% fish effected at the nominal 400, 500, and 600 mg/L test levels, respectively
Results with reference substance (positive control):
No data
Reported statistics and error estimates:
See table below
Sublethal observations / clinical signs:

Paires of variates: 3

Linear regression analysis (sinus transformation)

nominal concentration

x [mg/L]

Y [% effect)

lnx

arcsin y

400

10

5.99146455

-.9275295218

500

20

6.2146081

-.643501109

600

100

6.39692966

1.5708

Mean lnx value: 6.20100077

Mean value arcsin y: 1.22437874 E-06

Slope of regression: 5.981

Standard deviation of regression: 0.8893

Correlation coefficient: 0.888

Regression equation: y= -37.0885905 + 5.9810655 * x:

EC50: 493 mg/l

Standard error of EC50: 203 to 1200 mg/l (test substance)

95 % confidence interval of EC 50: 236 to 1033 mg/l

EC0: 379 mg/l (calculated)

EC100: 641 mg/l (calculated)

Validity criteria fulfilled:
not specified
Conclusions:
The 48-hour LC50 value was 493 mg/L.
Executive summary:

An acute study with methacrylic acid, monoester with propane-1,2-diol and the golden orfe (leuciscus idus melanotus) was conducted under static conditions at 20 ± 1°C. The study was conducted as a modified limit test with 1 replicate of ten fish per test concentration exposed to nominal concentrations of 400, 500, and 600 mg/L, over a 48-hour exposure period.  The study was conducted under GLPs with no analytical verification of test concentrations. The 48-hour LC50 value was 493 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Aquatic toxicity to fish of 2-hydroxyethyl methacrylate (CAS 868-77-9) and hydroxypropyl methacrylate (CAS 27813-02-1) is induced by narcosis. Correlation between hydrophobicity and narcotic effects of chemicals to the lipid phase of an aquatic organism is well known. Low hydrophobicity (in case HEMA and HPMA a log Pow of max. 1) of a chemical without a specific toxic effect is expected not to have a significant impact to aquatic organisms.
OECD tool box predicts the aquatic toxicity by Verhaar scheme into class 3 (unspecific reactivity) which means that no simple baseline toxicity (as also referred as narcosis) is expected. Jaworska et al (1998)1 have described a subtype of narcosis which tend to show higher toxicity than would be expected by non-polar narcosis and which they have called ester narcosis . For methacrylates it would be expected that after hydrolyzes by fish carboxyl esterases the metabolites methacrylic acid and/or the respective alcohol would impact the aquatic toxicity to fish of a methacrylic acid ester.
Metabolism of HEMA and HPMA have not been tested in fish liver but in vivo tests in rats have shown that the substances will hydrolyze into methacrylic acid and the alcohols ethylene glycol and propylene glycol, respectively within ca. 1 minute. (DOW 2017)
As the acute toxicity (LC50 96h) to fish of methacrylic acid in Onchorhynchus mykiss was tested to be 85 mg/l there would be an impact of the hydrolysis product methacrylic acid in the range 10-100 mg/l for the methacrylic acid moiety. No impact of the alcohols is excepted as LC50 (96h) of ethylene glycol (CAS 107-21-1-) for Pimephales promelas is 72.8 g/l and LC50 fish (96h) of propylene glycol (CAS 57-55-6) for Pimephales promelas is 55.7 g/l (Pillard, 1995)2

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
2-Hydroxyethyl methacrylate and hydroxypropyl methacrylate are highly pure mono-constituent substances with typical concentrations ≥ 98 % purity. No relevant impurities are included and thus no consequences on the relevant endpoints are to be expected. Typical impurity of both substances is methacrylic acid (CAS 79-41-4) in the range of 0.1 to 1 %, typically 0.1 %.

3. ANALOGUE APPROACH JUSTIFICATION
Hydroxypropyl methacrylate was tested in an acute aquatic toxicity test to fish acc. D38412 part 15 at nominal concentrations of 400, 500 and 600 mg/l with golden orfe (leuciscus idus melanotus) under static conditions for 48 h. LC50 (48h) was 493 mg/l. The study duration does not fulfill the requirements of OECD 203, Fish acute toxicity test, which requires a test duration of 96 h. Therefore a read across approach was performed with the structurally very similar substance 2-hydroxyethyl methacrylate.
No acute aquatic toxicity has been observed for 2-hydroxyethyl methacrylate and hydroxypropyl methacrylate at all three trophic levels (LC/EC 50 fish, daphnia and algae > 100 mg/l). As no toxicity was observed it can be expected that no specific aquatic toxicity exists for both hydroxy methacrylates and that the toxic effect is narcosis or more precisely ‘ester narcosis’ (see chapter 1. Hypotheses of read across) which correlates with the octanol-water partition coefficient (Log Pow). Although log Pow of hydroxypropyl methacrylate (0.97) is slightly higher than that of 2-hydroxyethyl methacrylate (0.42), the hydrophobicity of both substances is low and does not expect a strong impact on aquatic toxicity. The Environmental Agency of Japan has performed two limit tests with 2-hydroxypropyl methacrylate: a standard test acc. OECD 203 for 96 h and a prolonged test acc. OECD 204 for 14 d. In both tests EC 50 was > 100 mg/l. As no difference on the two other trophic levels Daphnia magna and algae has been observed between both substances and as LC 50 fish of hydroxypropyl methacrylate was 493 mg/l (nominal) after 48 hours, no acute toxicity to fish is expected after 96 h. (Since both substances are highly soluble in water and analytical findings in the aquatic tests were in the range of the nominal concentrations, the estimation of LC50 fish (48h) based on nominal concentrations is valid.)
In a read across approach with 2-hydroxyethyl methacrylate it could be shown that LC50 fish (96h) of hydroxypropyl methacrylate is > 100 mg/l which is valid for the assessment.

4. Data Matrix
see: Attached justification

1 Jaworska JS, Hunter RS, Schultz TW. (1998). Quantitative structure-toxicity relationships and volume fraction analyses for selected esters. Arch. Environ. Contam. Toxicol. 29: 86-93.
2 Pillard D, (1995) Comparative toxicity of formulated glycol deicers and pure ethylene and propylene glycol to Ceriodaphnia dubia and Pimephales promelas, Environ. Toxicology and Chemistry, Vol. 14, No 2: 311-315.
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Conclusions:
LC50 fish (96h) > 100 mg/l
Executive summary:

The acute toxicity to fish for over 96 h of hydroxypropyl methacrylate (HPMA)  was assessed by read across with 2-hydroxyethyl methacylate (HEMA). LC50 (96h) was > 100 mg/l in a limit test acc. OECD 203. As no specific toxicity of both  substances was observed in aquatic tests on all three trophic levels and therefore aquatic toxicity is expected to be based on narcosis or ester narcosis (Jaworska, 1998) and correlates with Log Pow, no  acute aquatic toxicity to fish is expected within 96 h as Log Pow of HEMA (log Pow: 0.42) and HPMA (log Pow: 0.97  ) do not vary significantly and are not in a range were a toxic effect to fish is expected. This  assumption is supported by prolonged fish test over 14 d by the same laboratory (Environmental Agency, Japan).


LC50 fish (96h) is expected to be > 100 mg/l  

Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Aquatic toxicity to fish of 2-hydroxyethyl methacrylate (CAS 868-77-9) and hydroxypropyl methacrylate (CAS 27813-02-1) is induced by narcosis. Correlation between hydrophobicity and narcotic effects of chemicals to the lipid phase of an aquatic organism is well known. Low hydrophobicity (in case HEMA and HPMA a log Pow of max. 1) of a chemical without a specific toxic effect is expected not to have a significant impact to aquatic organisms.
OECD tool box predicts the aquatic toxicity by Verhaar scheme into class 3 (unspecific reactivity) which means that no simple baseline toxicity (as also referred as narcosis) is expected. Jaworska et al (1998)1 have described a subtype of narcosis which tend to show higher toxicity than would be expected by non-polar narcosis and which they have called ester narcosis . For methacrylates it would be expected that after hydrolyzes by fish carboxyl esterases the metabolites methacrylic acid and/or the respective alcohol would impact the aquatic toxicity to fish of a methacrylic acid ester.
Metabolism of HEMA and HPMA have not been tested in fish liver but in vivo tests in rats have shown that the substances will hydrolyze into methacrylic acid and the alcohols ethylene glycol and propylene glycol, respectively within ca. 1 minute. (DOW 2017)
As the acute toxicity (LC50 96h) to fish of methacrylic acid in Onchorhynchus mykiss was tested to be 85 mg/l there would be an impact of the hydrolysis product methacrylic acid in the range 10-100 mg/l for the methacrylic acid moiety. No impact of the alcohols is excepted as LC50 (96h) of ethylene glycol (CAS 107-21-1-) for Pimephales promelas is 72.8 g/l and LC50 fish (96h) of propylene glycol (CAS 57-55-6) for Pimephales promelas is 55.7 g/l (Pillard, 1995)2

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
2-Hydroxyethyl methacrylate and hydroxypropyl methacrylate are highly pure mono-constituent substances with typical concentrations ≥ 98 % purity. No relevant impurities are included and thus no consequences on the relevant endpoints are to be expected. Typical impurity of both substances is methacrylic acid (CAS 79-41-4) in the range of 0.1 to 1 %, typically 0.1 %.

3. ANALOGUE APPROACH JUSTIFICATION
Hydroxypropyl methacrylate was tested in an acute aquatic toxicity test to fish acc. D38412 part 15 at nominal concentrations of 400, 500 and 600 mg/l with golden orfe (leuciscus idus melanotus) under static conditions for 48 h. LC50 (48h) was 493 mg/l. The study duration does not fulfill the requirements of OECD 203, Fish acute toxicity test, which requires a test duration of 96 h. Therefor a read across approach was performed with the structurally very similar substance 2-hydroxyethyl methacrylate.
No acute aquatic toxicity has been observed for 2-hydroxyethyl methacrylate and hydroxypropyl methacrylate at all three trophic levels (LC/EC 50 fish, daphnia and algae > 100 mg/l). As no toxicity was observed it can be expected that no specific aquatic toxicity exists for both hydroxy methacrylates and that the toxic effect is narcosis or more precisely ‘ester narcosis’ (see chapter 1. Hypotheses of read across) which correlates with the octanol-water partition coefficient (Log Pow). Although log Pow of hydroxypropyl methacrylate (0.97) is slightly higher than that of 2-hydroxyethyl methacrylate (0.42), the hydrophobicity of both substances is low and does not expect a strong impact on aquatic toxicity. The Environmental Agency of Japan has performed two limit tests with 2-hydroxypropyl methacrylate: a standard test acc. OECD 203 for 96 h and a prolonged test acc. OECD 204 for 14 d. In both tests EC 50 was > 100 mg/l. As no difference in the two other trophic levels Daphnia magna and algae has been observed between both substances and as LC 50 fish of hydroxypropyl methacrylate was 493 mg/l (nominal) after 48 hours, no acute toxicity to fish is expected after 96 h. (Since both substances are highly soluble in water and analytical findings in the aquatic tests were in the range of the nominal concentrations, the estimation of LC50 fish (48h) based on nominal concentrations is valid.)
In a read across approach with 2-hydroxyethyl methacrylate it could be shown that LC50 fish (96h) of hydroxypropyl methacrylate is > 100 mg/l which is valid for the assessment.
4. Data Matrix
see: Attached justification

1 Jaworska JS, Hunter RS, Schultz TW. (1998). Quantitative structure-toxicity relationships and volume fraction analyses for selected esters. Arch. Environ. Contam. Toxicol. 29: 86-93.
2 Pillard D, (1995) Comparative toxicity of formulated glycol deicers and pure ethylene and propylene glycol to Ceriodaphnia dubia and Pimephales promelas, Environ. Toxicology and Chemistry, Vol. 14, No 2: 311-315.

Reason / purpose for cross-reference:
read-across source
Key result
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Conclusions:
LC50 fish (96h) > 100 mg/l
Executive summary:

The acute toxicity to fish over 96 h of hydroxypropyl methacrylate (HPMA)  was assessed by read across with 2-hydroxyethyl methacylate (HEMA).HEMA was tested in a prolonged test over 14 days.  LC50 (14d) was > 100 mg/l in a limit test acc. OECD 204. As no specific toxicity of the substances was observed in aquatic tests on all three trophic levels an therefore aquatic toxicity is based on narcosis or ester narcosis (Jaworksa, 1998) and correlates with Log Pow no acute aquatic toxicity to fish is expected within 96 h as Log Pow of HEMA (log Pow: 0.42) and HPMA (log Pow: 0.97) do not vary significantly and are not in a range were a toxic effect to fish is expected. The prolonging of the limit test for 10 days performed in the same laboratory (Environmental Agency, Japan) confirms the absence of a toxic effect up to 100 mg/l and compensates the slightly higher log Pow of hydroxypropyl methacrylate in comparison to 2-hydroxyethyl methacrylate. 


LC50 (96h) of HPMA is assessed to be > 100 mg/l.

Description of key information

One acute freshwater fish study was available for methacrylic acid, monoester with hydroxypropyl methacrylate. The study was conducted with the golden orfe (Leuciscus idus melanotus) and was found to be of acceptable quality and assigned a Klimisch score of two. The study was conducted under static conditions, under GLPs and following national standard test methods. LC50 (48h) was 493 mg/l. Though the exposure was conducted for 48 hours instead of the standard 96-hour exposure, a read across approach was performed with 2-hydroxyethyl methacrylate. The Environmental Agency of Japan has performed two limit tests with 2-Hydroxypropyl methacrylate: a standard test acc. OECD 203 for 96 h and a prolonged test acc. OECD 204 for 14 d. In both tests EC 50 was > 100 mg/l. As no toxicity has been observed in all three tests toxicity is expected to be based on narcosis. . Although log Pow of hydroxypropyl methacrylate (0.97) is slightly higher than that of 2-hydroxyethyl methacrylate (0.42), the hydrophobicity of both substances is low and does not expect a strong impact on aquatic toxicity.


In a read across approach with 2-hydroxyethyl methacrylate has been that LC50 fish (96h) of hydroxypropyl methacrylate is > 100 mg/l which is valid for the assessment.


Data on marine fish are not available.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
> 100 mg/L

Additional information

no data ar availble for marine fish