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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-04-29 till 2010-06-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, well described, performed according to a current OECD guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.20 (Daphnia magna Reproduction Test)
Deviations:
no
Principles of method if other than guideline:
The method described in the Council Regulation (EC) No 440/2008, Method C.20 'Daphnia magna Reproduction Test'' (2008), which equals to the OECD Test guideline 211 (Daphnia magna Reproduction Test; adopted: Sept. 21, 1998), assesses adverse effects of various concentrations of a test item to a freshwater micro crustacean species within a 21 day exposure period under semi-static conditions.
The purpose of this method was to determine the NOEC and the LOEC for the parthenogenetic reproduction rate and, if possible, for the mortality/ immobilisation rate of parent Daphnia. If no adverse effects were recorded at a maximum test concentration of 10 mg/L (LOEC > 10 mg/L) no higher concentrations need to be tested.
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- examined by chemical analysis (HPLC) at 0 and 21 days
Vehicle:
no
Details on test solutions:
A stock solution was prepared to give the desired series of test concentrations. To achieve this 4.9 – 5.3 mg of the test item were added to 1 litre of dilution water (one exception on 2010-04-29 was made, 10.3 mg were added to 2 litres dilution water), treated for 1 h in an ultrasonic bath and stirred for 24 h on a magnetic stirrer. Finally undissolved particles of the test item were removed by filtration using folded filters of pore size 7-12 µm. The pH was measured to be pH 7.8 – 8.0.
To produce the different test item concentrations appropriate amounts of the stock solution were diluted with dilution water to a volume of 100 mL per replicate. For each test item concentration and control 10 replicates were prepared.
Test organisms (species):
Daphnia magna
Details on test organisms:
Test species
- Name: Daphnia magna STRAUS, parthenogenetic females
- Source: Strain of Bundesgesundheitsamt Berlin
- Maintenance and Acclimatisation: A population of parthenogenetic females of synchronized age structure has been maintained for more than 15 years in the test facility under constant temperature conditions (20 +/- 1 °C) at a 16 : 8 hour light-dark photoperiod (illumination: < 1000 lux). The culture water (so-called 'M4 medium') was partly renewed once a week. The Daphnia were exclusively fed with unicellular green algae (Desmodesmus subspicatus) 'ad libitum'. Mortalities of parent Daphnia during the culture period were recorded daily in a semi-quantitative way. The neonates were separated from their parent Daphnia by filtration prior to the acute test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
14.7 – 15.5 °dH (= 262.4 – 276.7 mg/L CaCO3)
Test temperature:
temperature range: 18 - 22 °C with a maximum temperature fluctuation of +/- 1 °C
pH:
8.0 - 8.3
Dissolved oxygen:
8.5 - 9.6 mg/L
Nominal and measured concentrations:
The following nominal concentrations of the test item were tested in the acute test: 0.21, 0.47, 1, 2.3 and 5 mg/L.
Details on test conditions:
Exposure conditions
- Test vessels: 150 mL glass beakers holding 1 neonate in 100 mL of test medium
- Experimental design: 5 test concentration plus 1 control, 1 neonate per vessel, 10 replicates per concentration/control, semi-static system (renewal of the test media on Monday, Wednesday and Friday) respectively.
- Method of initiation: neonates were placed in prepared media
- Photoperiod: 16 h light: 8 h dark
- Light intensity: not exceeding 800 lux
- Temperature of incubation unit: 19.0 to 21.0 °C
- Aeration: none
- Test item concentration/s: 0.0032, 0.01, 0.032, 0.1 and 0.32 mg/L
- Food source and : Desmodesmus subspicatus
- feeding rate:day 0-7: 0.1 mg C / Daphnia / day
day 8-21: 0.2 mg C / Daphnia / day
- Duration of exposure: 21 days
- Criteria of effects: The criterion of adverse effects used in this study was the item-induced inhibitory effect on the parthenogenetic reproduction rate and the mobility behaviour/mortality rate of parent Daphnia, all effects being assessed at least three times a week
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.028 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.087 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
The results are expressed in terms of time-weighted mean measured concentrations. Effective concentrations ranged from 95.0 – 103.1 % of the nominal values in the freshly prepared media and from 68.8 – 92.0 % in the media after 48 hours, or 72 hours of exposure, respectively.
Validity criteria fulfilled:
yes
Conclusions:
The following validity criteria of the test were met:
The mortality rate in the controls did not exceed 20 % by the end of the test.
Living offspring produced per parent Daphnia surviving at the end of the test was = 60 in the controls.
The dissolved oxygen concentration remained above 3 mg/L throughout the exposure period.
The pH was within the range 6-9.
Water hardness was above the recommended value of 140 mg/L (as CaCO3).
Executive summary:

The chronic toxicity of 4 -Hydroxydiphenylamine to Daphnia magna was investigated in a static test according to Council Regulation (EC) No 440/2008, Method C.20 'Daphnia magna Reproduction Test'' (2008), which equals to the OECD Test guideline 211 (Daphnia magna Reproduction Test; 1998). After 21 days a NOEC of 0.028 mg/L and a LOEC of 0.087 mg/L was determined (Currenta, 2010).

Description of key information

The chronic toxicity of 4 -Hydroxydiphenylamine to Daphnia magna was investigated in a static test according to Council Regulation (EC) No 440/2008, Method C.20 'Daphnia magna Reproduction Test'' (2008), which equals to the OECD Test guideline 211 (Daphnia magna Reproduction Test; 1998). After 21 days a NOEC of 0.028 mg/L was determined.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.028 mg/L

Additional information

4-Hydroxydiphenylamine (4 -HPDA) is the hydrolysis product from N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine (7PPD). A secondary hydrolysis product is p-hydroquinone.

 

The lowest effect value in long-term tests was found for p-hydroquinone (0.007 mg/L, expressed in 7PPD equivalents) which is lower than the value for 4-HDPA (0.028 mg/L).Although p-hydroquinone is a secondary hydrolysis product of 7PPD, it was not chosen as a source of key value as the formation of p-Hydroquinone from 7PPD by hydrolysis is rather slow.