Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: acceptable calculation method

Specific details on test material used for the study:

- sponsor's identification: Amine C8
- Description: dark brown liquid
- Batch number: T7-271109
- Date received 21 September 2010
- Expiry date: 31 December 2011
- Storage conditions: room temperature in the dark

Test organisms (species):

Daphnia magna

Water media type:

freshwater

Dose descriptor:

NOEC

Effect conc.:

> 1 mg/L

Remarks on result:

other: expected NOEC based on ACR approach

Acute:Chronic Ration approach

Source	Description	ACR (90%-ile)	Expected NOEC (mg/L): EC50 (> 100 mg/L) / ACR
Table 40	All species (geometric mean)	71	> 1
Table 40	All invertebrates (geometric mean)	79	>1
Table 41	All species (individual species)	71.2	>1
Table 41	All invertebrates (individual species)	94.5	> 1
Table 42	Mode of action (narcotic) (*)	11.5	(>1)
Table 43	Invertebrates (Daphnia magna)	44	>1
Table 45	Daphnia magna / organics	20	>1

 *not applicable for secondary amines

- short term toxicity test on invertebrates: EC50 (48 h) mg/L: >100 mg/L

- conclusion:

table 40, 41, 43: expected NOEC >1 mg/L

table 42, 45: expected NOEC >1 mg/L

Conclusions:

table 40, 41, 43: expected NOEC >1 mg/L
table 42, 45: expected NOEC >1 mg/L

Description of key information

No experimental data available.

Additional information

In Annex IX Section 9.1.5 column 2 of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing on aquatic invertebrates shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on invertebrates. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or CLP-Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB.  The hazard assessment of the substance reveals that the substance is not a PBT, nor a vPvB substance. In Annex XI Section 3, it is laid down that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the intermediate use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 10). Therefore, a long-term toxicity test on aquatic invertebrates is not provided.

In addition, the acute-to-chronic ratio (ACR) as determined following the ECETOC Technical Report No. 93 (Aquatic Hazard Assessment II; ECETOC, 2003) shows that a long-term NOEC for daphnids of > 1 mg/L is to be expected.