Reaction mass of methyl acetate and methanol

Sediment toxicity

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

sediment toxicity: long-term

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Reference 2

Endpoint:

sediment toxicity: short-term

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

Please refer to IUCLID section 13 for Read Across Justification.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

54 890 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 53200-56630 mg/L

Reference 3

Endpoint:

sediment toxicity: short-term

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

Please refer to IUCLID section 13 for Read Across Justification.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

3 min

Dose descriptor:

EC50

Effect conc.:

71 700 mg/L

Conc. based on:

test mat.

Basis for effect:

other: inhibition of movement

Reference 4

Endpoint:

sediment toxicity: short-term

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Laboratory test performed according to standard procedures, but poorly documented and without information on important test parameters, like temperature. Tested species is not standard organism and is also not included in any of the National and international standard methods / Guidelines listed in the EChA Guidance on Information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance (November 2012).

Qualifier:

according to guideline

Guideline:

other: APHA (1989) Standard methods for the examination of water and wastewater, 18th ed

GLP compliance:

not specified

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Branchiura sowerbyi

Details on test organisms:

-Mean length: 20 +/- 7 mm
-Mean weight: 2.05 +/- 1.25 mg

Study type:

laboratory study

Test type:

semi-static

Water media type:

freshwater

Duration:

96 h

Exposure phase:

total exposure duration

Hardness:

109 +/- 7.2 mg/L as CaCO3

Test temperature:

not reported

pH:

7.34 +/- 0.12

Dissolved oxygen:

6.45 +/- 0.56 mg/L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

54 890 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 53200 - 56630

Validity criteria fulfilled:

not specified

Conclusions:

In a 96-hour semi-static freshwater test with Branchiura sowerbyi according to an national method (APHA, 1989; Standard methods for the examination of water and wastewater) ten worms (four replicates) were used for each concentration of methanol. The 96 h LC50 was determined to be 54890 mg/L (nominal).

Reference 5

Endpoint:

sediment toxicity: short-term

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

New short term toxicity test for Tubifex, verified by statistical comparison with other toxicity data.

Principles of method if other than guideline:

New short term (3 min) test for Tubifex

GLP compliance:

not specified

Test organisms (species):

Tubifex tubifex

Study type:

laboratory study

Test type:

static

Water media type:

freshwater

Duration:

3 min

Exposure phase:

total exposure duration

Test temperature:

room temperature

Reference substance (positive control):

yes

Remarks:

manganese chloride CAS: 20603-88-7

Key result

Duration:

3 min

Dose descriptor:

EC50

Effect conc.:

71 700 mg/L

Conc. based on:

test mat.

Basis for effect:

other: inhibition of movement

Validity criteria fulfilled:

not specified

Conclusions:

In a freshwater short-term toxicity test with Tubifex tubifex under static conditions a 3-minute EC50 of 7700 mg/L (based on inhibition of movement) was derived. This result was verified by statistical comparison with other toxicity data.

Description of key information

In compliance with REACH Annex X this endpoint was waived because the chemical safety assessment of the registration substance did not reveal the need to investigate further effects to sediment organisms.

Additional information

According to column 2 in Annex X to Regulation (EC) 1907/2006 (REACH) testing of long-term toxicity to sediment organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further effects on sediment organisms. The registration substance is neither classified for environmental hazards according to Regulation (EC) 1272/2008 (CLP), nor is it identified as PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. This conclusion is supported by assessments for the structural analogues Methanol (CAS 67-56-1) and Methyl acetate (CAS 79-20-9) provided in its public ECHA REACH dossiers demonstrating that long-term toxicity to sediment organisms is not to be expected. Therefore, generating additional data is scientifically not justified.

However, data on the toxicity of the read across source substance Methanol is publicly available.

In a 96-hour semi-static freshwater test with Branchiura sowerbyi according to an national method (APHA, 1989; Standard methods for the examination of water and wastewater) ten worms in four replicates were used for each concentration of methanol. The 96 h LC50 was found to be 54890 mg/L in nominal (Kaviraj et al., 2004).

In a freshwater short-term toxicity test with Tubifex tubifex under static conditions a 3-minute EC50 of 7700 mg/L (based on inhibition of movement) was derived. This result was verified by statistical comparison with other toxicity data (Tichy, 2007).

Conclusion

Available information from public literature on effects of methanol on sediment organisms indicates very low  acute toxicity. Moreover, since the substance exhibits a low log Pow and low log Koc exposure of sediment organisms is unlikely and testing towards sediment dwelling organisms not necessary. The equilibrium partitioning method can be used for assessing the hazard of sediment organisms. The expected low toxicity towards sediment organisms is underlined by the available studies of Tichy (2007) and Kaviraj (2004) where an EC50 of 71700 mg/L for Tubifex tubifex and a LC50 of 54890 mg/L were observed. Furthermore, the equilibrium partitioning method can be used for assessing the hazard of sediment organisms.