Reaction mass of 2,2'-(Ethylenedioxy)diethanol and 3,6,9-Trioxaundecane-1,11-diol

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

other: ASTM E-47.01

Principles of method if other than guideline:

- Method: ASTM E-47.01, Draft No. 3, 1980 (Standard for Toxicity Tests With the Early Life Stages of Fisheries)

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

- Concentrations: TEG concentrations in test water were measured weekly

Vehicle:

no

Details on test solutions:

TEG was introduced with adosing apparatus, which delivered 1L of seawater to each treatment at 5 cycleslh. and Hamilton Precision Liquid Dispenser 11 pumps,®5 which injected measured amounts of TEG at each cyde.

Test organisms (species):

Menidia peninsulae

Details on test organisms:

TEST ORGANISM
- Common name: tidewater silverside
- Method of breeding: To begin the early life-stage toxicity test, tidewater silverside embryos were
obtained using thc methods of Middaugh et al
Embryos at Stage were collectcd from filter floss on whieh spawning occurred, fibrils were removed, and they were randomly placed in incubation cups
- Feeding during test : Foods for hatched fish included rotifers, Brachiolltls plicatilis, three times daily for the first fivc days, rotifers and Artemia nauplii (24 to 32-h posthydration of cysts) twice daily for the next three days, and only Artemia riauplii twice daily until termination of the test.

Test type:

flow-through

Water media type:

saltwater

Limit test:

no

Total exposure duration:

28 d

Test temperature:

25 +/- 2 °C

pH:

7.69 - 7.73

Dissolved oxygen:

7.1 - 7.2 mg/L

Salinity:

20 +/- 2 parts per hundred

Nominal and measured concentrations:

- Concentrations (mg/L): 3.2, 10, 32, 100, 320, 1000 (nominal)
- Concentrations (mg/L): ND*, ND*, 15, 40, 230, 1500 (measured)

* Nondetectable (< 10.0 mg/L)

Details on test conditions:

TEST CONDITIONS
- Sea water from Santa Rosa Sound was filtered (20-µg filter), aerated, heated in a reservoir to required temperature and delivered to test aquaria
- Salinity was maintained by dilution of natural seawater with deionized freshwater


TEST SYSTEM
- Test vessel: for embryos: incubation caps; for fish - aquaria
- Size of vessel: 2-L (fish)
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: glass, 2 L (fish)
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): 1L of seawater to each treatment at 5 cycleslh
- No. of vessels per concentration (replicates): Two incubation cups were placed in each of two duplicate 2-L aquaria per treatment



EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Embryo and fry survival were observed daily and mortality was recorded.
survival of embryos to hatching, survival of fry, and fish weight at 28 days were monitored

Duration:

28 d

Dose descriptor:

LC50

Effect conc.:

> 1 500 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

> 40 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

weight

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

> 40 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Table 1.

Concentration [mg/L]		Survival [%]			Average	Percentage of
nominal	measured	Embryos	Fry	Combined	Wet Weight [mg]	Control Weight
control	ND	100	83	83	13.2	-
3,2	ND	94	93	83	14.2	109
10	ND	98	89	88	12.4	94
32	15	100	62	62	13.9	105
100	40	94	81	75	12.1	92
320	230	91	86	78	10.8	82
1000	1500	97	55	53	9.7	73

Statistically significant differences were found in weight and survival at the highest test concentrations (230 and 1500 mg/L).

---------------------------------------------------------------------------------------------------------------

Weight:

Average weight of fish exposed to 230 mg/L was 18 % less than average control weight, while average weight of fish exposed to 1500 mg/L was 26% less than average control weight.

Survival:

In the 1500 mg/L treatment, the significant effect in combined survival (embryo and fry) was 36 % less than that of the control. Survival of embryos was significantly different from the control at 230 mg/L but not at 1500 mg/L. This suggests that the effect observed in the 230 mg/L treatment may not be caused by toxicity of the test item because the response was not concentration dependent.

Reference 2

Endpoint:

long-term toxicity to fish, other

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Qualifier:

no guideline followed

Principles of method if other than guideline:

ECOSAR v2.0: Estimation of chronic toxicity to fish for chemical class "Neutral Organic SAR (Baseline Toxicity)"

GLP compliance:

no

Test organisms (species):

other: fish

Water media type:

freshwater

Total exposure duration:

30 d

Remarks on exposure duration:

chronic exposure

Duration:

30 d

Dose descriptor:

other: Chronic toxicity (ChV)

Effect conc.:

18 639.7 mg/L

Nominal / measured:

estimated

Conc. based on:

act. ingr.

Basis for effect:

other: chronic toxicity (not specified)

Remarks on result:

other: ECOSAR chemical class: "Neutral Organic SAR (Baseline Toxicity)"; The substance is in the applicability domain of the model.

Reference 3

Endpoint:

long-term toxicity to fish, other

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Qualifier:

no guideline followed

Principles of method if other than guideline:

ECOSAR v2.0: Estimation of chronic toxicity to fish for chemical class "Neutral Organic SAR (Baseline Toxicity)"

GLP compliance:

no

Test organisms (species):

other: fish

Water media type:

freshwater

Total exposure duration:

30 d

Remarks on exposure duration:

chronic exposure

Duration:

30 d

Dose descriptor:

other: Chronic toxicity (ChV)

Effect conc.:

41 268 mg/L

Nominal / measured:

estimated

Conc. based on:

act. ingr.

Basis for effect:

other: chronic toxicity (not specified)

Remarks on result:

other: ECOSAR chemical class: "Neutral Organic SAR (Baseline Toxicity)"; The substance is in the applicability domain of the model.

Description of key information

Overall, experimental and estimated chronic values are clearly greater than 1 mg/L with regard to classification limits and also greater than 10 mg/L, which the limit concentration in long-term toxicity testing; therefore, long-term effects on fish are not to be expected.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

NOEC

Effect concentration:

> 40 mg/L

Additional information

QSAR-disclaimer

In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met.

According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.

For the assessment of the substance (Q)SAR results were used for the estimation of the chronic toxicity to fish. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.

Assessment

2,2'-(ethylenedioxy)diethanol 3,6,9-trioxaundecane-1,11-diol (EC 907-131-0) is a multi-constituent substance. The main constituents of EC 907-131-0 are triethylene glycol (TGE, CAS 112-27-6, 10-80% w/w) and tetraethylene glycol (Tetra-EG, CAS 112-60-7, 10-80% w/w). Since no data on the long-term toxicity to fish of the reaction mass of 2,2'-(ethylenedioxy)diethanol 3,6,9-trioxaundecane-1,11-diol are available, the assessment is based on the available data for the main components triethylene glycol (CAS 112-27-6) and tetraethylene glycol (112-60-7).

The early life stage test was conducted with triethylene glycol according to the standard of ASTM (E-47.01, Draft No. 3, 1980 - Standard for Toxicity Tests With the Early Life Stages of Fisheries). In this study survival, hatching and growth (weight) of embryos from the saltwater species Menidia peninsulae were monitored. The test organisms were exposed under flow-through conditions for 28 days. Statistically significant differences were found in weight and survival at the highest test concentrations (230 and 1500 mg/L, measured, Montgomery et al., 1985). Nevertheless, since the survival of the embryos was significantly different from the control at 230 mg/L but not at 1500 mg/L, the effect observed was not concentration dependent. Hence, it has to be expected that the effect in the 230 mg/L treatment may not be caused by toxicity of the test item. However, the key NOEC of > 40 mg/L (measured, based on weight and mortality) was used as the key value as the worst-case consideration.

Additionally, for both constituents of EC 907-131-0 long-term toxicity to fish was determined using a valid QSAR model (ECOSAR v2.0; BASF SE, 2022). The model predicts the chronic value ChV, which is defined as the geometric mean of the no-observed-effect concentration (NOEC) and the lowest-observed-effect concentration (LOEC). The ChV for CAS 112-27-6 and CAS 112-60-7 were predicted to be 18640 and 41268 mg/L respectively. Both substances are within the applicability domain of the model.

Overall, experimental and estimated chronic values are clearly greater than 1 mg/L with regard to classification limits and also greater than 10 mg/L, which the limit concentration in long-term toxicity testing; therefore, long-term effects on fish are not to be expected.