Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol

Toxicity to terrestrial plants

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to terrestrial plants: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 Mar - 20 Aug 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

GLP Guideline study. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Landwirtschaft und Forsten, Wiesbaden, Germany

Analytical monitoring:

no

Vehicle:

yes

Details on preparation and application of test substrate:

- Method of mixing into soil: Test item was solved in 30 mL acetone and mixed with fine quartz sand under a fume hood until the solvent was evaporate. Then the quartz sand with the test item was mixed into the soil until the sand is dispersed homogeneously. The soil was mixed with the quartz sand for minimum 5 min.
- Controls: yes
- Chemical name of vehicle: acetone
- Concentration of vehicle in test medium: 30 mL acetone was mixed with quartz sand and after evaporation the sand was mixed into soil.
- Evaporation of vehicle before use: yes

Species:

Raphanus sativus

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: raddish
- Plant family: Brassicaceae

Species:

Glycine max (G. soja)

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Soybean
- Plant family: Fabaceae

Species:

Avena sativa

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name: Oat
- Plant family: Gramineae

Test type:

seedling emergence and seedling growth test

Study type:

laboratory study

Substrate type:

natural soil

Limit test:

no

Total exposure duration:

21 d

Test temperature:

day: 23 ± 4 °C, night: 18 ± 4 °C (Avena sativa and Raphamus sativus)
day: 23 - 25 °C, night: 18 - 19 °C (Glycine max)

Details on test conditions:

TEST SYSTEM
- Testing facility: Institut für Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany
- Test container (type, material, size): commercial plastic flower pots of 16 cm (diameter) and 9 x 9 cm
- Method of seeding: Seeds were added manually into the soil.
- No. of replicates per treatment group: 8
- No. of replicates per control: 8
- No. of replicates per vehicle control: 8

SOURCE AND PROPERTIES OF SUBSTRATE
- Geographic location: Soil was delivered by the LUFA, Speyer, Germany (Lufa 2.3, sandy loam; USDA)
- Organic matter (%): 1.0 - 1.4%
- Particle size: < 0.2 cm
- pH: 6.1 - 6.6

GROWTH CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity and quality: 5130 - 14600 lux (test item), 5500 - 17630 lux (reference substance "Glycerides of saturated C8/C10 fatty acids"), 5150 - 18210 lux (reference substance "Coconut oil")
- Day/night temperatures: day: 23 ± 4 °C, night: 18 ± 4 °C (Avena sativa and Raphamus sativus); day: 23 - 25 °C, night: 18 - 19 °C (Glycine max)
- Relative humidity (%): day: 70%, night: approx. 85% (Avena sativa and Raphamus sativus); day: 57 - 80%, night: 70 - 100% (Glycine max)
- Watering regime and schedules: Irrigation with tap water was done automatically with fibreglass-wicks connection soil and water supply (bowl standing below each pot and containing maximum 500 mL water). Water supply was not permanent. Water was given as soon as the soil started to dry out.
- Water source/type: tap water
- Any pest control method/fertilization: Flory 9 (Euflor) 1 g/L with Sequestren (Ciba-Geigy) 0.05 g/L was given once in four times a week after development of the first true leaves.

EFFECT PARAMETERS MEASURED: germination (day 7, 14, 21), phytotoxicity (day 7, 14, 21), growth stages (day 21), mortality (day 21), fresh weight (day 21)

- Phytotoxicity rating system: EPPO Standard 135

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.25

Nominal and measured concentrations:

nominal: 0, 39, 87.8, 197.5, 444, 1000 mg/kg soil dw

Reference substance (positive control):

yes

Remarks:

Glycerides of saturated C8/C10 fatty acids and Coconut oil

Species:

Avena sativa

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

87.8 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

phytotoxicity

Key result

Species:

Avena sativa

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

39 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Species:

Avena sativa

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

263.79 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Remarks on result:

other: 95% CL: 140.51 - 557.95 mg/kg soil dw

Species:

Raphanus sativus

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

197.5 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: germination and phytotoxicity

Species:

Raphanus sativus

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

87.8 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Species:

Raphanus sativus

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

526.47 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Species:

Glycine max (G. soja)

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

197.5 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Species:

Glycine max (G. soja)

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

2 978.54 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Remarks on result:

other: 95% CL: 1022.51 - 11862235 mg/kg soil dw

Details on results:

SEED GERMINATION
- Percent seed germination: 80 - 93% (Avena sativa), 68 - 100% (Raphanus sativus), 93 - 100% (Glycine max)

Results with reference substance (positive control):

- Other: The reference substances showed significant effects on germination, fresh weight and phytotoxicity for Avena sativa and Raphanus sativus. For Glycine max, the germination and the fresh weight were reduced using Glycerides of saturated C8/C10 fatty acids; the fresh weight was reduced using coconut oil.

The control plants (incl. solvent control) showed normal growth throughout the test and germination rates of the species exceeded the standard of the guideline.

Table 1: Summary of effective concentrations (based on fresh weight) for Avena sativa, Raphanus sativus and Glycine max.

	NOEC [mg/kg soil]	LOEC [mg/kg soil]	EC25 [mg/kg soil]	EC50 [mg/kg soil]
Avena sativa	39.00	87.80	75.45	263.79
Raphanus sativus	87.80	197.50	180.65	526.47
Glycine max	197.50	444.0	431.94	2978.54

 

Avena sativa

Germination: The germination rate was statistically significantly reduced at 444 mg/kg soil (80 %). At all other concentrations (incl. 1000 mg/kg soil) no effect on germination rate was observed therefore it is assumed, that the reduction was not treatment related.

Mortality: Mortality was not observed.

Fresh Weight: Statistically significant reduction of fresh weight occurred from 87.8 mg/kg soil onwards (28 - 68%).

Phytotoxicity at Day 21: Phytotoxic effects appeared as slight growth reduction from 197.5 mg/kg onwards (1 to 10%). Growth stages were reduced from this concentration.

 

Glycine max

Germination: Effects on germination rate were not observed.

Mortality: Mortality was not observed.

Fresh Weight: Fresh weight was statistically reduced from 444 mg/kg soil and above (30 to 33%).

Phytotoxicity at Day 21: Phytotoxic effects were not observed. Slight reduction in growth stages occurred from 197.5 mg/kg soil onwards but did not increase with increasing concentrations.

Raphanus sativus

Germination: The germination rate was statistically significantly reduced from 444 mg/kg soil onwards (68 - 75%‚ control: 91%).

Mortality: Mortality was not observed.

Fresh Weight: Statistically significant reduction of fresh weight occurred from 197.5 mg/kg soil onwards (28 -59%).

Phytotoxicity at Day 21: Phytotoxic effects (7 to 19%) appeared as reduction of growth stages which was observed from 444 mg/kg soil onwards.

 

The most sensitive species in fresh weight was Avena sativa with an EC 50 of 263.79 mg/kg soil, followed by Raphanus sativus and Glycine max with an EC50 of 526.47 and 2978.54 mg/kg soil, respectively.

 

The test substance caused a statistically significant reduction in germination of Raphanus sativus (from 444 mg/kg soil onwards) but did not affect germination rate of Avena sativa and Glycine max. Mortality did not occur in soil treated with the test substance.

Phytotoxic effects appeared as reduction of growth stages of Raphanus sativus and Avena sativa.

Conclusions:

After 21 d the NOEC for Avena sativa (concerning fresh weight) was determined to be 39 mg/kg soil dw.

Reference 2

Endpoint:

toxicity to terrestrial plants: short-term

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

20 Mar - 20 Aug 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

GLP Guideline study. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Justification for type of information:

Please refer section 13 for read across justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Landwirtschaft und Forsten, Wiesbaden, Germany

Analytical monitoring:

no

Vehicle:

yes

Details on preparation and application of test substrate:

- Method of mixing into soil: Test item was solved in 30 mL acetone and mixed with fine quartz sand under a fume hood until the solvent was evaporate. Then the quartz sand with the test item was mixed into the soil until the sand is dispersed homogeneously. The soil was mixed with the quartz sand for minimum 5 min.
- Controls: yes
- Chemical name of vehicle: acetone
- Concentration of vehicle in test medium: 30 mL acetone was mixed with quartz sand and after evaporation the sand was mixed into soil.
- Evaporation of vehicle before use: yes

Species:

Raphanus sativus

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: raddish
- Plant family: Brassicaceae

Species:

Glycine max (G. soja)

Plant group:

Dicotyledonae (dicots)

Details on test organisms:

- Common name: Soybean
- Plant family: Fabaceae

Species:

Avena sativa

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name: Oat
- Plant family: Gramineae

Test type:

seedling emergence and seedling growth test

Study type:

laboratory study

Substrate type:

natural soil

Limit test:

no

Total exposure duration:

21 d

Test temperature:

day: 23 ± 4 °C, night: 18 ± 4 °C (Avena sativa and Raphamus sativus)
day: 23 - 25 °C, night: 18 - 19 °C (Glycine max)

Details on test conditions:

TEST SYSTEM
- Testing facility: Institut für Biologische Analytik und Consulting IBACON GmbH, Rossdorf, Germany
- Test container (type, material, size): commercial plastic flower pots of 16 cm (diameter) and 9 x 9 cm
- Method of seeding: Seeds were added manually into the soil.
- No. of replicates per treatment group: 8
- No. of replicates per control: 8
- No. of replicates per vehicle control: 8

SOURCE AND PROPERTIES OF SUBSTRATE
- Geographic location: Soil was delivered by the LUFA, Speyer, Germany (Lufa 2.3, sandy loam; USDA)
- Organic matter (%): 1.0 - 1.4%
- Particle size: < 0.2 cm
- pH: 6.1 - 6.6

GROWTH CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity and quality: 5130 - 14600 lux (test item), 5500 - 17630 lux (reference substance "Glycerides of saturated C8/C10 fatty acids"), 5150 - 18210 lux (reference substance "Coconut oil")
- Day/night temperatures: day: 23 ± 4 °C, night: 18 ± 4 °C (Avena sativa and Raphamus sativus); day: 23 - 25 °C, night: 18 - 19 °C (Glycine max)
- Relative humidity (%): day: 70%, night: approx. 85% (Avena sativa and Raphamus sativus); day: 57 - 80%, night: 70 - 100% (Glycine max)
- Watering regime and schedules: Irrigation with tap water was done automatically with fibreglass-wicks connection soil and water supply (bowl standing below each pot and containing maximum 500 mL water). Water supply was not permanent. Water was given as soon as the soil started to dry out.
- Water source/type: tap water
- Any pest control method/fertilization: Flory 9 (Euflor) 1 g/L with Sequestren (Ciba-Geigy) 0.05 g/L was given once in four times a week after development of the first true leaves.

EFFECT PARAMETERS MEASURED: germination (day 7, 14, 21), phytotoxicity (day 7, 14, 21), growth stages (day 21), mortality (day 21), fresh weight (day 21)

- Phytotoxicity rating system: EPPO Standard 135

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.25

Nominal and measured concentrations:

nominal: 0, 39, 87.8, 197.5, 444, 1000 mg/kg soil dw

Reference substance (positive control):

yes

Remarks:

Glycerides of saturated C8/C10 fatty acids and Coconut oil

Species:

Avena sativa

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

87.8 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

phytotoxicity

Key result

Species:

Avena sativa

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

39 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Species:

Avena sativa

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

263.79 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Remarks on result:

other: 95% CL: 140.51 - 557.95 mg/kg soil dw

Species:

Raphanus sativus

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

197.5 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: germination and phytotoxicity

Species:

Raphanus sativus

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

87.8 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Species:

Raphanus sativus

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

526.47 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Species:

Glycine max (G. soja)

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

197.5 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Species:

Glycine max (G. soja)

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

2 978.54 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: fresh weight

Remarks on result:

other: 95% CL: 1022.51 - 11862235 mg/kg soil dw

Details on results:

SEED GERMINATION
- Percent seed germination: 80 - 93% (Avena sativa), 68 - 100% (Raphanus sativus), 93 - 100% (Glycine max)

Results with reference substance (positive control):

- Other: The reference substances showed significant effects on germination, fresh weight and phytotoxicity for Avena sativa and Raphanus sativus. For Glycine max, the germination and the fresh weight were reduced using Glycerides of saturated C8/C10 fatty acids; the fresh weight was reduced using coconut oil.

The control plants (incl. solvent control) showed normal growth throughout the test and germination rates of the species exceeded the standard of the guideline.

Table 1: Summary of effective concentrations (based on fresh weight) for Avena sativa, Raphanus sativus and Glycine max.

	NOEC [mg/kg soil]	LOEC [mg/kg soil]	EC25 [mg/kg soil]	EC50 [mg/kg soil]
Avena sativa	39.00	87.80	75.45	263.79
Raphanus sativus	87.80	197.50	180.65	526.47
Glycine max	197.50	444.0	431.94	2978.54

 

Avena sativa

Germination: The germination rate was statistically significantly reduced at 444 mg/kg soil (80 %). At all other concentrations (incl. 1000 mg/kg soil) no effect on germination rate was observed therefore it is assumed, that the reduction was not treatment related.

Mortality: Mortality was not observed.

Fresh Weight: Statistically significant reduction of fresh weight occurred from 87.8 mg/kg soil onwards (28 - 68%).

Phytotoxicity at Day 21: Phytotoxic effects appeared as slight growth reduction from 197.5 mg/kg onwards (1 to 10%). Growth stages were reduced from this concentration.

 

Glycine max

Germination: Effects on germination rate were not observed.

Mortality: Mortality was not observed.

Fresh Weight: Fresh weight was statistically reduced from 444 mg/kg soil and above (30 to 33%).

Phytotoxicity at Day 21: Phytotoxic effects were not observed. Slight reduction in growth stages occurred from 197.5 mg/kg soil onwards but did not increase with increasing concentrations.

Raphanus sativus

Germination: The germination rate was statistically significantly reduced from 444 mg/kg soil onwards (68 - 75%‚ control: 91%).

Mortality: Mortality was not observed.

Fresh Weight: Statistically significant reduction of fresh weight occurred from 197.5 mg/kg soil onwards (28 -59%).

Phytotoxicity at Day 21: Phytotoxic effects (7 to 19%) appeared as reduction of growth stages which was observed from 444 mg/kg soil onwards.

 

The most sensitive species in fresh weight was Avena sativa with an EC 50 of 263.79 mg/kg soil, followed by Raphanus sativus and Glycine max with an EC50 of 526.47 and 2978.54 mg/kg soil, respectively.

 

The test substance caused a statistically significant reduction in germination of Raphanus sativus (from 444 mg/kg soil onwards) but did not affect germination rate of Avena sativa and Glycine max. Mortality did not occur in soil treated with the test substance.

Phytotoxic effects appeared as reduction of growth stages of Raphanus sativus and Avena sativa.

Conclusions:

After 21 d the NOEC for Avena sativa (concerning fresh weight) was determined to be 39 mg/kg soil dw.

Description of key information

NOEC (21d) 39 mg/kg soil based on freshweight of Avena sativa (OECD 208)

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for terrestrial plants:

39 mg/kg soil dw

Additional information

Since no studies investigating the toxicity to terrestrial plants of the target substance are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the structurally related substance butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) was conducted. This read-across is justified in detail in the overall summary (IUCLID chapter 6.3) and within the analogue justification in IUCLID Section 13.

The study was performed according to OECD 208 with two dicotyledon (Raphanus sativus & Glycine max) and one monocotyledon species (Avena sativa) (Spatz, 2002). Five different concentrations up to 1000 mg/kg soil were tested and the effect parameters germination, phytotoxicity, growth stages, mortality and fresh weight were measured. The most sensitive species based on fresh weight was Avena sativa with an NOEC (21d) of 39 mg/kg soil, followed by Raphanus sativus and Glycine max with an NOEC (21d) of 87.8 and 197.5 mg/kg soil, respectively. Moreover, the test substance caused a statistically significant reduction in germination of Raphanus sativus (from 444 mg/kg soil onwards) but did not affect germination rate of Avena sativa and Glycine max. Phytotoxic effects appeared as reduction of growth stages of Raphanus sativus and Avena sativa. No mortality occurred in soil treated with the test substance. All tested species showed the same effects, which are not typical phytotoxic effects as known for plant protection products (e.g. chlorosis and necrosis). The effects are resembled more growth depression like caused by a permanent water deficiency from the beginning of germination. Observed effects might have been caused by obstruction of water uptake through the roots.

Based on the results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by an equal ecotoxicological profile, it can be concluded that the effects of the target substance will be in the same range.