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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Initiation date: 1989.04.25 Completion date: 1989.05.03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study is complete, performed under GLP and valid. however no analysis was performed and thus the usability for riskassessment purposes is limited when assessing the bioavailable fraction.
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Qualifier:
according to guideline
Guideline:
other: S.A.L.M. Kooyman. "Parametric analyses of mortality rates in bio-assays". Water Research 15(1981)107-119.
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
A stock solution of 25 gil was prepared by dissolving the test substance in demineralized water containing concentrated HCl.
The presence of the test substance in the test medium caused a change of the pH, which is outside the range that can be supported by the test animal. Therefore, the pH was neutralized both in the stock solution and in the dilution water to a value
between 7.0 and 7.3. The chosen test concentrations were prepared by dilution of the stock solution.
Test organisms (species):
Daphnia magna
Details on test organisms:
The test organism was Daphnia magna; they were produced in the Akzo Research Laboratories Arnhem, dept. CRL according to NEN 6503 and Standard Operating Procedures SOP CRL T2. They were less than 24 hours old at the beginning of the test.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
73.1 mg Ca/l, 20.4 mg Mg/l, 14.9 °dH
Test temperature:
19.7 - 20.8 °C
pH:
7.1-7.9
Dissolved oxygen:
9.0-9.2 mg/L
Nominal and measured concentrations:
nominal: 10, 18, 32, 56, 100 mg/L
Details on test conditions:
The temperature was kept between 19.7 and 20.8 °C, and the light regime was 16 hours ambient light per day.
The duration of the test was 48 hours.
The test vessels were 400 ml glass beakers, containing 250 ml of test medium. Each beaker contained 5 test animals.
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
17.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CI: 15.3-20.0 mg/L
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
No effect on mobility was observed at 10 mg/l and 100% immobilisation was observed at 32 mg/l. The EC50-48 h is 17.5 mg/l. The 95% confidence limits are 15.3 and 20.0 mg/l.
The quality criteria of the test have been fulfilled: the immobilization in the control was <10%, the oxygen concentration was >2 mg/l at the end of the test, and the Daphnids in the control group have not been trapped at the surface of the water (less than 10%).
Reported statistics and error estimates:
The EC50 was determined by an LC50 program of Griffioen (R1ZA) based on a model of Kooyman (1981).

Nominal concentration mg/L

Cumulative mobile animals

0h

24h

48h

Control

60

60 (7)

60 (5)

10

20

20 (2)

20 (1)

18

20

20 (3)

9

32

20

14

0

56

20

4

0

100

20

0

0

( ) = swims but sticks to the surface

Validity criteria fulfilled:
yes
Conclusions:
No effect on mobility was observed at 10 mg/l and 100% immobilisation was observed at 32 mg/l. The EC50-48 h is 17.5 mg/l. The 95% confidence limits are 15.3 and 20.0 mg/l. The test meets all validity criteria and therefore is valid. The test was performed under GLP. The usability of the test reults when performing a riskassessment is limited due to the fact that only nominal concentrations are presented. This results in no information on the actuals bio-available concentration.
Executive summary:

pentaethylenehexamine (PEHA) was tested in an acute toxicity test with the water flea (Daphnia magna). The test was performed according to the EEC method, part c.: Methods for the determination of ecotoxicity, C.2. Acute toxicity for Daphnia.

The test was carried out as a static test, in which the solution was not renewed.

No mortality was observed up to 10 mg/l. The EC50 was 17.5 mg/l, with 95% confidence limits of 15.3 and 20.0 mg/l nominal. The quality criteria of the test have been fulfilled: the immobilization in the control was <10%, the oxygen concentration was >2 mg/l at the end of the test, and the Daphnids in the control group have not been trapped at the surface of the water (less than 10%). The usability of the test reults when performing a riskassessment is limited due to the fact that only nominal concentrations are presented. This results in no information on the actuals bio-available concentration.

Description of key information

EC50(48h): 17.5 mg/L (nominal) 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
17.5 mg/L

Additional information

The short-term toxicity of the substance to aquatic invertebrates was tested according to EU method C.2 and S.A.L.M. Kooyman. "Parametric analyses of mortality rates in bio-assays". Water Research 15(1981)107-119. The study was conducted with Daphnia magna as test organism. The daphnids were exposed to nominal substance concentrations of 10, 18, 32, 56 and 100 mg/L. Analytical dose verification was not performed since the substance was expected to be stable under the tested conditions.

The test was terminated after 48 hours. The determined EC50(48h) is 17.5 mg/L (nominal).