Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 June 2012 - 05 July 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study carried out to international guidelines and to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

EC Number:

700-792-4

Molecular formula:

C26H51NO2, C28H55NO2

IUPAC Name:

Reaction mass of 1,2,2,6,6-pentamethylpiperidin-4-yl hexadecanoate and 1,2,2,6,6-pentamethylpiperidin-4-yl octadecanoate

Details on test material:

- Name of test material (as cited in study report): T-1640L
- Substance type:
- Physical state: fawn coloured wax
- Analytical purity: 98.7%
- Purity test date: 20 May 2011
- Lot/batch No.: 10121
- Expiration date of the lot/batch: 12 Aoril 2013
- Stability under test conditions: stable
- Storage condition of test material: refrigerated in the dark, desiccated

Sampling and analysis

Analytical monitoring:

no

Test substrate

Vehicle:

no

Details on preparation and application of test substrate:

- Method of mixing into soil (if used): electric hand held mixer
- Controls: water, Chloroacetamide
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): none

Test organisms

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Eisenia fetida
- Source: In-house culture at Huntingdon Research Centre
- Age at test initiation (mean and range, SD): no data
- Weight at test initiation (mean and range, SD): 300 - 600 mg

ACCLIMATION
- Acclimation period: no
- Acclimation conditions (same as test or not):
- Health during acclimation (any mortality observed):

Study design

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

14 d

Test conditions

Test temperature:

19.8 - 20.6 °C

Moisture:

35%

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 1 litre, glass
- Amount of soil or substrate: 2200 g divided
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): 70% quartz sand, 20% kaolin clay, 10% sphagnum peat
- Organic carbon (%):
- Maximum water holding capacity (in % dry weight):
- CEC:
- Pretreatment of soil: pH adjusted to 6.0 ± 0.5 with calcium carbonate

OTHER TEST CONDITIONS
- Photoperiod: no data
- Light intensity: between 520 and 796 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Daily observations for behavioural and pathological signs
Mortality on days 7 and 14
Bodyweights prior to treatment and on day 14

VEHICLE CONTROL PERFORMED: no, no vehicle

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8

Nominal and measured concentrations:

Nominal concentrations: 95.3, 171.5, 308.6, 555.6, 1000 mg active ingredient/kg

Reference substance (positive control):

yes

Remarks:

chloroacetamide

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

7 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Effect concentrations 2

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Effect concentrations 3

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Details on results:

- Mortality at end of exposure period: 0 in any group
- Total mass of adults at beginning of test:
- Changes in body weight of live adults (% of initial weight) at end of exposure period:
Control +8.3
95.3 T-1640L +10.2
171.5 T-1640L +5.0
308.6 T-1640L +2.0
555.6 T-1640L -0.5
1000 T-1640L -1.5
- No. of offspring produced: no data
- No. of unhatched cocoons: no data
- Morphological abnormalities: none
- Behavioural abnormalities: none

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Relevant effect levels: mortality, 39 of 40 worms died

Reported statistics and error estimates:

Bodyweights were compared using Analysis of variance, followed by a two-tailed Williams’ test (1971, 1972).
The decrease in bodyweight at 1000 mg a.i./kg was statistically significant - (p <0.05) - in comparison to the increase in the control.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

At seven and 14 days after treatment there was no mortality in any of the T-1640L treatment groups.
The 7 and 14-day LC50 values were estimated to be >1000 mg a.i./kg dry soil.
The No Observed Effect Concentration was 1000 mg a.i.kg/dry soil.
There was a significant treatment related difference in bodyweight between the treatment and control group at 1000 mg a.i./kg dry soil only
(p <0.05).
The study was considered valid because less than 10% mortality was observed in the water control group.