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Diss Factsheets

Ecotoxicological information

Toxicity to terrestrial plants

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Administrative data

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Endpoint:
toxicity to terrestrial plants: long-term
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex IX, the study does not need to be conducted since direct and indirect exposure of the soil compartments is unlikely.
Endpoint:
toxicity to terrestrial plants: short-term
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
A reference substance (toxic standard) was not included in the experimental design. Neither description of the test method followed nor data on GLP.
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Study on inhibition of germination, i.e. seedling emergence, of lettuce fruit (Lactuca saliva L. cv. Great Lakes).
- Short description of test conditions: see below
- Parameters analysed / observed: 3 day-EC50
GLP compliance:
not specified
Specific details on test material used for the study:
Test compound was used as received from the manufacturer without further purification.
Vehicle:
no
Details on preparation and application of test substrate:
- Method of application: Agar (0.5%) was used as a germination substrate and contained the test compounds in solution
- Controls: germination substrate only with water
Species:
Lactuca sativa
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: lettuce fruit
- Plant family: asteraceae
- Variety: Great Lakes
Test type:
seedling emergence toxicity test
Study type:
semi-field study
Substrate type:
artificial soil
Remarks:
agar (0.5%)
Limit test:
yes
Total exposure duration:
3 d
Test temperature:
30 ºC
Details on test conditions:
Ambient light
Reference substance (positive control):
no
Key result
Species:
Lactuca sativa
Duration:
3 d
Dose descriptor:
EC50
Effect conc.:
> 5 other: mM
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
germination
Remarks on result:
other: effect limited by test item solubility in water
Validity criteria fulfilled:
no
Conclusions:
The 3 day-EC50 based on inhibition of germination for the test item on lettuce fruit (Lactuca saliva L. cv. Great Lakes) was estimated to be higher than 5 mM (681.2 mg/L).
Executive summary:

A Study on inhibition of germination of lettuce fruit (Lactuca saliva L. cv. Great Lakes) was performed on alicyclic compounds including some monoterpenes and in particular on L-camphene. Agar (0.5%) was used as a germination substrate and contained the test compound in solution. The test was carried out for 3 days at 30 °C in ambient light. A negative control based on the same substrate only with water was used. The 3 day-EC50 for the test item was estimated to be higher than 5 mM (681.2 mg/L).

Endpoint:
toxicity to terrestrial plants: short-term
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
A reference substance (toxic standard) was not included in the experimental design. Neither description of the test method followed nor data on GLP.
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Study on inhibition of germination, i.e. seedling emergence, of lettuce fruit (Lactuca saliva L. cv. Great Lakes).
- Short description of test conditions: see below
- Parameters analysed / observed: 3 day-EC50
GLP compliance:
not specified
Specific details on test material used for the study:
Test compound was used as received from the manufacturer without further purification.
Vehicle:
no
Details on preparation and application of test substrate:
- Method of application: Agar (0.5%) was used as a germination substrate and contained the test compounds in solution
- Controls: germination substrate only with water
Species:
Lactuca sativa
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: lettuce fruit
- Plant family: asteraceae
- Variety: Great Lakes
Test type:
seedling emergence toxicity test
Study type:
semi-field study
Substrate type:
artificial soil
Remarks:
agar (0.5%)
Limit test:
yes
Total exposure duration:
3 d
Test temperature:
30 ºC
Details on test conditions:
Ambient light
Reference substance (positive control):
no
Key result
Species:
Lactuca sativa
Duration:
3 d
Dose descriptor:
EC50
Effect conc.:
1.3 other: mM
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
germination
Remarks on result:
other: confidence limit: ±0.5mM
Validity criteria fulfilled:
no
Conclusions:
The 3 day-EC50 based on inhibition of germination for the test item on lettuce fruit (Lactuca saliva L. cv. Great Lakes) was estimated to be 1.3±0.5mM (177±68 mg/L).
Executive summary:

A Study on inhibition of germination of lettuce fruit (Lactuca saliva L. cv. Great Lakes) was performed on alicyclic compounds including some monoterpenes and in particular on alpha pinene. Agar (0.5%) was used as a germination substrate and contained the test compound in solution. The test was carried out for 3 days at 30 °C in ambient light. A negative control based on the same substrate only with water was used. The 3 day-EC50 for the test item was estimated to be 1.3±0.5mM (177±68 mg/L).

Endpoint:
toxicity to terrestrial plants: short-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance alpha pinene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format.
Reason / purpose for cross-reference:
read-across source
Key result
Species:
Lactuca sativa
Duration:
3 d
Dose descriptor:
EC50
Effect conc.:
1.3 other: mM
Nominal / measured:
estimated
Conc. based on:
other: Read-across from an analogue
Basis for effect:
germination
Remarks on result:
other: read-across from an analogue for which EC50 (3d) = 1.3 mM (confidence limit: ±0.5mM)
Validity criteria fulfilled:
not applicable
Conclusions:
Based on the read-across approach from the analogue alpha pinene, the 3 day-EC50 for the reaction mass based on inhibition of germination on lettuce fruit (Lactuca saliva L. cv. Great Lakes) was estimated to be 1.3±0.5mM (177±68 mg/L).
Executive summary:

A Study on inhibition of germination of lettuce fruit (Lactuca saliva L. cv. Great Lakes) was performed on alicyclic compounds including some monoterpenes and in particular on alpha pinene. Agar (0.5%) was used as a germination substrate and contained the test compound in solution. The test was carried out for 3 days at 30 °C in ambient light. A negative control based on the same substrate only with water was used. The 3 day-EC50 for the test item was estimated to be 1.3±0.5mM (177±68 mg/L). Based on these results, the read-across approach was applied and the 3 day-EC50 for the reaction mass was estimated to be 1.3±0.5mM (177±68 mg/L).

Endpoint:
toxicity to terrestrial plants: short-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance L-camphene which shares the same functional groups with the main components of the multi-constituent substance reaction mass of fenchene and laevo camphene and dextro camphene and laevo alpha pinene also has comparable values for the relevant molecular properties.
See attached the reporting format.
Reason / purpose for cross-reference:
read-across source
Key result
Species:
Lactuca sativa
Duration:
3 d
Dose descriptor:
EC50
Effect conc.:
> 5 other: mM
Nominal / measured:
estimated
Conc. based on:
other: Read-across from an analogue
Basis for effect:
germination
Remarks on result:
other: read-across from an analogue for which EC50 (3 d) > 5 mM
Validity criteria fulfilled:
not applicable
Conclusions:
Based on the read-across approach from the analogue L-camphene, the 3 day-EC50 for the reaction mass based on inhibition of germination on lettuce fruit (Lactuca saliva L. cv. Great Lakes) was estimated to be higher than 5 mM (681.2 mg/L).

Executive summary:

A Study on inhibition of germination of lettuce fruit (Lactuca saliva L. cv. Great Lakes) was performed on alicyclic compounds including some monoterpenes and in particular on L-camphene. Agar (0.5%) was used as a germination substrate and contained the test compound in solution. The test was carried out for 3 days at 30 °C in ambient light. A negative control based on the same substrate only with water was used. The 3 day-EC50 for the test item was estimated to be higher than 5 mM (681.2 mg/L). Based on these results, the read-across approach was applied and the 3 day-EC50 for the reaction mass was estimated to be higher than 5 mM (681.2 mg/L).

Description of key information

Data waiving (exposure considerations): According to the column 2 of REACH Annex IX, the study does not be conducted since direct and indirect exposure of the soil compartment is unlikely.

Supporting study: Read-across approach. L-camphene: Based on the read-across approach from the analogue L-camphene, the 3 day-EC50 for the reaction mass based on inhibition of germination on lettuce fruit (Lactuca saliva L. cv. Great Lakes) was estimated to be higher than 5 mM (681.2 mg/L).

Supporting study: Read-across approach. alpha pinene: Based on the read-across approach from the analogue alpha pinene, the 3 day-EC50 for the reaction mass based on inhibition of germination on lettuce fruit (Lactuca saliva L. cv. Great Lakes) was estimated to be 1.3±0.5mM (177±68 mg/L).

Key value for chemical safety assessment

Additional information

Data waiving (exposure considerations): According to the column 2 of REACH Annex IX, the study does not be conducted since direct and indirect exposure of the soil compartment is unlikely.

Supporting study: Read-across approach. L-camphene: A Study on inhibition of germination of lettuce fruit (Lactuca saliva L. cv. Great Lakes) was performed on alicyclic compounds including some monoterpenes and in particular on L-camphene. Agar (0.5%) was used as a germination substrate and contained the test compound in solution. The test was carried out for 3 days at 30 °C in ambient light. A negative control based on the same substrate only with water was used. The 3 day-EC50 for the test item was estimated to be higher than 5 mM (681.2 mg/L). Based on these results, the read-across approach was applied and the 3 day-EC50 for the reaction mass was estimated to be higher than 5 mM (681.2 mg/L).

Supporting study: Read-across approach. alpha pinene: A Study on inhibition of germination of lettuce fruit (Lactuca saliva L. cv. Great Lakes) was performed on alicyclic compounds including some monoterpenes and in particular on alpha pinene. Agar (0.5%) was used as a germination substrate and contained the test compound in solution. The test was carried out for 3 days at 30 °C in ambient light. A negative control based on the same substrate only with water was used. The 3 day-EC50 for the test item was estimated to be 1.3±0.5mM (177±68 mg/L). Based on these results, the read-across approach was applied and the 3 day-EC50 for the reaction mass was estimated to be 1.3±0.5mM (177±68 mg/L).