Propane-1,2-diyl dibenzoate

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 September 1997 - 17 September 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD and EC test guidelines, and in compliance with GLP.

Justification for type of information:

A discussion and report on the read across strategy is presented as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Eathworm
- Source: Earthworms were obtained from Mrs H. Baker, Brickyard Farm, Buckworth Road, Alconbury Weston, Cambridgeshire, England.

ACCLIMATION
- Acclimation period: 20 days
- Health during acclimation (any mortality observed): no mortalities

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

14 d

Test temperature:

23 to 25°C

pH:

approximately 6.0

Moisture:

35% of the dry weight of soil

Details on test conditions:

TEST SYSTEM

- Composition (if artificial substrate):
Industrial quartz sand 70% w/w
Kaolin clay 20%w/w
Sphagnum peat 10% w/w


OTHER TEST CONDITIONS
- Photoperiod: Continuous lighting
- Light intensity: 700 lux


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
On Days 7 and 14 the medium was emptied from the test containers and the worms removed for counting. Mortalities live worms and those unaccounted for were recorded. Mortality was assessed by testing the reaction of each worm to a mechanical stimulus at either end. On Day 7 the medium was returned to the containers and surviving worms replaced on the surface.


VEHICLE CONTROL PERFORMED: yes


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Test concentrations: Dose levels based on study guidelines.

Nominal and measured concentrations:

Nominally 0 (control), 95, 171, 309, 556 and 1000 ppm.

Reference substance (positive control):

yes

Remarks:

chloroacetamide

Key result

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 other: ppm

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

1 000 other: ppm

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

- Mortality at end of exposure period: Seven mortalities occurred during the study but were not considered to be related to treatment
- Total mass of adults at beginning of test: 300 - 600 mg per worm
- Changes in body weigth of live adults (% of initial weight) at end of exposure period: All groups showed a decrease in bodyweight over the study A small weight loss is not unusual and frequently occurs in studies ofthis type Notreatment related trend was evident

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Relevant effect levels: Day 14 LC50 46 ppm

Conclusions:

Under the conditions of this study the LC50 value of DPGDB to the earthworm was found to be in excess of 1000 ppm. The no observed effect level (NOEL) was considered to be 1000 ppm.

Executive summary:

There is no data available for propylene glycol dibenzoate (PGDB). Relevant information is available from a structural analogue Dipropylene glycol dibenzoate (DPGDB). The justification for read across is presented as an attachment included in Section 13 of the IUCLID dossier.

An acute toxicity study to earthworms was conducted to determine the effect of the test material, DPGDB. The study was conducted according to OECD and EU test guidelines, and in compliance with GLP.

Groups of earthworms were exposed to DPGDB at levels 0 (control), 95, 171, 309, 556 and 1000 ppm in an artificial standard soil, for a test period of 14 days. Each treatment and control group consisted of four replicate containers, each with ten worms per container (forty worms per group, total).

No mortalities were seen during the study, and all worms were normal in appearance on days 7 and 14 of the test.. Under the conditions of this study, the LC₅₀ value of DPGDB to the earthworm was found to be in excess of 1000 ppm. The no observed effect level (NOEL) was considered to be 1000 ppm.

Reference 2

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Description of key information

There is no data available for propylene glycol dibenzoate (PGDB). Relevant information is available from a structural analogue Dipropylene glycol dibenzoate (DPGDB). The justification for read across is presented as an attachment included in Section 13 of the IUCLID dossier.

Short-term toxicity

In an OECD Guideline 207 acute toxicity study in earthworms, conducted to determine the effects of DPGDB, no mortalities were observed and all worms were normal in appearance on days 7 and 14 of the test. Under the conditions of this study, the LC₅₀ value of DPGDB to the earthworm was found to be in excess of 1000 ppm. The no observed effect level (NOEL) was considered to be 1000 ppm (Huntingdon Life Sciences, 1998e; Klimisch score = 1).

Long-term toxicity

Annex IX of Regulation (EC) No 1907/2006 states that long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicate the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. It is also stated that these studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. There are no defined uses where direct exposure of this substance to the soil compartment is likely. Also, as this substance is readily biodegradable, it can be assumed that it will be biodegraded within the STP process and as a consequence indirect transfer to the soil compartment from sludge is not expected. Furthermore, the results from an earthworm study (Huntingdon Life Sciences, 1998e; Klimisch score = 1) have been used to assess the hazard to terrestrial organisms and further investigation of the effects of the substance and/or its breakdown products on additional terrestrial organisms is not justified and are therefore waived.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw