Registration Dossier

Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

long-term toxicity to aquatic invertebrates
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
supporting study
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:
Dose descriptor:
Effect conc.:
> 1 mg/L
Remarks on result:
other: expected NOEC based on ACR approach

Acute:Chronic Ration approach



ACR (90%-ile)

Expected NOEC (mg/L): EC50

(> 100 mg/L) / ACR

Table 40

All species

(geometric mean)


> 1

Table 40

All invertebrates

(geometric mean)



Table 41

All species

(individual species)



Table 41

All invertebrates

(individual species)


> 1

Table 42

Mode of action (narcotic) (*)



Table 43


(Daphnia magna)



Table 45

Daphnia magna / organics



 *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

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.

Key value for chemical safety assessment

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.