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EC number: 214-730-4 | CAS number: 1191-16-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.77 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 57.66 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- see discussion
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.54 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 65.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- see discussion
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
No data on repeated dose toxicity are available for prenyl acetate. However, repeated dose toxicity data on the structurally and metabolically related prenol (3-methylbut-2-en-1-ol; CAS No. 556-82-1) are taken into account for assessment via read across. This read across is justified, based on the high likelihood that prenyl acetate would rapidly be hydrolized to prenol and acetate in the GIT and liver, and/or show a similar GIT / liver metabolism profile as prenol.
In the subchronic oral (drinking water) repeated dose toxicity study in Wistar rats (BASF AG, 2002), major adverse test substance related effects were reduced food and water consumption, leading to significantly decreased body weights/ body weight gains, decreased urinary volume and increased urinary specific gravity. The NOAEL has been set at 1000 ppm (65.4 mg/kg bw/day in males, 82.1 mg/kg bw/day in females).
In the prenatal developmental toxicity study in Wistar rats (BASF AG, 2002), oral (gavage) administration of prenol (600 mg/kg bw/day) resulted in adverse clinical findings (salivation, lacrimation, abdominal position and piloerection), reduced food consumption, reduced body weight / body weight gain of the dams. The test substance administration evoked no signs of developmental toxicity. The NOAEL for maternal toxicity has been set at 200 mg/kg bw/day and >= 600 mg/kg bw/day (the highest dose tested) for developmental toxicity.
The respective NOAEL of 65.4 mg/kg bw/day for male rats (82.1 mg/kg bw/day for female rats) has been taken as conservative point of departure for the systemic DNELs derived, which covers findings observed in the subchronic repeated dose and developmental toxicity study.
Route to route extrapolation:
No experimental data on absorption of prenyl acetate are available. Based on the physicochemical properties prenyl acetate is considered to show good bioavailability via the dermal and oral route. On the basis of the low vapour pressure, the exposure with prenyl acetate via inhalation as a vapour is low. According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route-specific information to include a default factor in the case of inhalation-to-oral extrapolation, assuming 50% oral and 100% inhalation absorption. Due to the lack of experimental data a default factor of 1 for oral-to-dermal extrapolation is used for the DNEL derivation.
For the worker, the following DNELs were derived:
For derivation of the long-term systemic inhalative DNEL for prenyl acetate, the oral NOAEL of 65.4 mg/kg bw/d was taken as a basis and converted into a corrected inhalative NOAEC of 57.66 mg/m3according to the procedure, recommended in the current guidance document (R8, ECHA 2008). Applying all assessment factors, the inhalative long-term systemic DNEL was set at 5.77 mg/m3 for the worker.
Long-term – inhalation, systemic effects
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 65.4 mg/kg bw/day |
|
Step 2) Modification of starting point |
50%/100%
0.38 m3/kg bw
6.7 m3/10 m3
|
Ratio of oral (rat) to inhalation (human) absorption (default value, as proposed in the REACH guidance (R.8.4.2)
Standard respiratory volume of a rat, corrected for 8 h exposure, as proposed in the REACH Guidance (R.8.4.2)
Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 m3) |
Modified dose-descriptor |
NOAEC corrected inhalative = 65.4 * (50/100) * (1/0.38) * (6.7/10) = 57.66 mg/m3 |
|
Step 3) Assessment factors |
|
|
Allometric scaling |
1 |
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation according to R8 ECHA 2008. |
Remaining differences |
1 |
Substance specific assessment factor: Besides unspecific general effects such as clinical signs, impaired body weights and changes in urine, predominantly as secondary consequence of reduced water and food consumption, no specific test substance related organ toxicity has been observed. The intensive taste and odor of the test substance solutions used is likely to be the cause of the major adverse effects observed after oral application. Since oral administration is not a relevant route of exposure, the relevance of these findings is doubtful for workers. On the basis of these findings, no toxicodynamic and/or additional toxicokinetic differences between test animals and humans is to be expected. Overall, no additional AF for remaining differences is considered mandatory. |
Intraspecies |
5 |
Default assessment factor according to R8 ECHA 2008 was used as worst case to cover uncertainties due to the read across made. |
Exposure duration |
2 |
Use of a subchronic study as starting point for long-term systemic DNEL derivation (default assessment factor according to R8 ECHA 2008). |
Dose response |
1 |
according to R8 ECHA 2008 |
Quality of database |
1 |
according to R8 ECHA 2008 (GLP guideline Study) |
DNEL |
Value |
|
|
57.66 / (1 x 1 x 5 x 2 x 1 x 1) = 5.77 mg/m3 |
For derivation of the long-term systemic dermal DNEL of prenyl acetate, the oral NOAEL of 65.4 mg/kg bw/d was taken as a basis and was converted into a corrected dermal NOAEL of 65.4 mg/kg bw/d according to the procedure, recommended in the current guidance document (R8, ECHA 2008). Applying all assessment factors, the dermal long-term systemic DNEL derived was 6.54 mg/kg bw/d for the worker.
Long-term – dermal, systemic effects
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 65.4 mg/kg bw/day |
|
Step 2) Modification of starting point |
1 |
Default assessment factor for oral to dermal extrapolation according to R8 ECHA 2008 was used due to lack of experimental data on dermal penetration rate. |
Modified dose-descriptor |
NOAEL corrected dermal = 65.4 * 1 = 65.4 mg/kg bw/d |
|
Step 3) Assessment factors |
|
|
Allometric scaling |
1 |
Substance specific assessment factor: Adverse effects observed were unspecific general effects such as clinical signs, impaired body weights and changes in urine, predominantly as secondary consequence of reduced water and food consumption. The intensive taste and odor of the test substance solutions used is likely to be the cause of the major adverse effects observed after oral application. These findings are not expected to depend on a systemic toxic parent compound/metabolite being excreted dependent of caloric demand. Therefore, use of AF >1 for allometric scaling is not considered necessary based on the nature of effects observed. |
Remaining differences |
1 |
Substance specific assessment factor: Besides unspecific general effects such as clinical signs, impaired body weights and changes in urine, predominantly as secondary consequence of reduced water and food consumption, no specific test substance related organ toxicity has been observed. The intensive taste and odor of the test substance solutions used is likely to be the cause of the major adverse effects observed after oral application. Since oral administration is not a relevant route of exposure, the relevance of these findings is doubtful for workers. On the basis of these findings, no toxicodynamic and/or additional toxicokinetic differences between test animals and humans is to be expected. Overall, no additional AF for remaining differences is considered mandatory. |
Intraspecies |
5 |
Default assessment factor according to R8 ECHA 2008 was used as worst case to cover uncertainties due to the read across made. |
Exposure duration |
2 |
Use of a subchronic study as starting point forlong-term systemic DNEL derivation (default assessment factor according to R8 ECHA 2008). |
Dose response |
1 |
according to R8 ECHA 2008 |
Quality of database |
1 |
according to R8 ECHA 2008 (GLP guideline Study) |
DNEL |
Value |
|
|
65.4 / (1 x 1 x 5 x 2 x 1 x 1) = 6.54 mg/kg bw/day |
No DNELs were derived for local effects after short term or after long term inhalative exposure, as the substance exhibits no hazardous potential in terms of these endpoints and the conservatively derived long term inhalative DNEL for systemic effects covers putative local effects. No DNELs were derived for systemic effects after short term dermal or inhalative exposure, as the substance exhibits no hazardous potential in terms of these endpoints and the conservatively derived respective long term DNELs for systemic effects sufficiently covers such putative effects.
No DNEL for local effects after short term/ long term dermal exposure was derived. Data for skin sensitization identify prenyl acetat as not skin sensiziting in a weight of evidence and do not fulfill the respective classification and labeling criteria. Furtherrmore prenyl acetate was found to be not irritating to skin.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.42 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 28.43 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- see discussion
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.27 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 65.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- see discussion
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.27 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 65.4 mg/kg bw/day
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
No data on repeated dose toxicity are available for prenyl acetate. However, repeated dose toxicity data on the structurally and metabolically related prenol (3-methylbut-2-en-1-ol; CAS No. 556-82-1) are taken into account for assessment via read across. This read across is justified, based on the high likelihood that prenyl acetate would rapidly be hydrolized to prenol and acetate in the GIT and liver, and/or show a similar GIT / liver metabolism profile as prenol.
In the subchronic oral (drinking water) repeated dose toxicity study in Wistar rats (BASF AG, 2002), major adverse test substance related effects were reduced food and water consumption, leading to significantly decreased body weights/ body weight gains, decreased urinary volume and increased urinary specific gravity. The NOAEL has been set at 1000 ppm (65.4 mg/kg bw/day in males, 82.1 mg/kg bw/day in females).
In the prenatal developmental toxicity study in Wistar rats (BASF AG, 2002), oral (gavage) administration of prenol (600 mg/kg bw/day) resulted in adverse clinical findings (salivation, lacrimation, abdominal position and piloerection), reduced food consumption, reduced body weight / body weight gain of the dams. The test substance administration evoked no signs of developmental toxicity. The NOAEL for maternal toxicity has been set at 200 mg/kg bw/day and >= 600 mg/kg bw/day (the highest dose tested) for developmental toxicity.
The respective NOAEL of 65.4 mg/kg bw/day for male rats (82.1 mg/kg bw/day for female rats) has been taken as conservative point of departure for the systemic DNELs derived, which covers findings observed in the subchronic repeated dose and developmental toxicity study.
Route to route extrapolation:
No experimental data on absorption of prenyl acetate are available. Based on the physicochemical properties prenyl acetate is considered to show good bioavailability via the dermal and oral route. On the basis of the low vapour pressure, the exposure with prenyl acetate via inhalation as a vapour is low. According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route-specific information to include a default factor in the case of inhalation-to-oral extrapolation, assuming 50% oral and 100% inhalation absorption. Due to the lack of experimental data a default factor of 1 for oral-to-dermal extrapolation is used for the DNEL derivation.
For the general population, the following DNELs were derived:
For derivation of the long-term systemic inhalative DNEL for prenyl acetate, the oral NOAEL of 65.4 mg/kg bw/d was taken as a basis and converted into a corrected inhalative NOAEC of 28.43 mg/m3according to the procedure, recommended in the current guidance document (R8, ECHA 2008). Applying all assessment factors, the inhalative long-term systemic DNEL was set at 1.42 mg/m3for the general population.
Long-term – inhalation, systemic effects
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 65.4 mg/kg bw/day |
|
Step 2) Modification of starting point |
50%/100%
1.15 m3/kg bw
|
Ratio of oral (rat) to inhalation (human) absorption (default value, as proposed in the REACH guidance (R.8.4.2)
Standard respiratory volume of a rat, corrected for 24 h exposure, as proposed in the REACH Guidance (R.8.4.2) |
Modified dose-descriptor |
NOAEC corrected inhalative = 65.4 * (50/100) * (1/1.15) = 28.43 mg/m3 |
|
Step 3) Assessment factors |
|
|
Allometric scaling |
1 |
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation according to R8 ECHA 2008. |
Remaining differences |
1 |
Substance specific assessment factor: Besides unspecific general effects such as clinical signs, impaired body weights and changes in urine, predominantly as secondary consequence of reduced water and food consumption, no specific test substance related organ toxicity has been observed. The intensive taste and odor of the test substance solutions used is likely to be the cause of the major adverse effects observed after oral application. On the basis of these findings, no toxicodynamic and/or additional toxicokinetic differences between test animals and humans is to be expected. Overall, no additional AF for remaining differences is considered mandatory. |
Intraspecies |
10 |
Default assessment factor according to R8 ECHA 2008 was used as worst case to cover uncertainties due to the read across made. |
Exposure duration |
2 |
Use of a subchronic study as starting point forlong-term systemic DNEL derivation (default assessment factor according to R8 ECHA 2008). |
Dose response |
1 |
according to R8 ECHA 2008 |
Quality of database |
1 |
according to R8 ECHA 2008 (GLP guideline Study) |
DNEL |
Value |
|
|
28.43 / (1 x 1 x 10 x 2 x 1 x 1) = 1.42 mg/m3 |
For derivation of the long-term systemic dermal DNEL of prenyl acetate, the oral NOAEL of 65.4 mg/kg bw/d was taken as a basis and was converted into a corrected dermal NOAEL of 65.4 mg/kg bw/d according to the procedure, recommended in the current guidance document (R8, ECHA 2008). Applying all assessment factors, the dermal long-term systemic DNEL derived was 3.27 mg/kg bw/d for the general population.
Long-term – dermal, systemic effects
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 65.4 mg/kg bw/day |
|
Step 2) Modification of starting point |
1 |
Default assessment factor for oral to dermal extrapolation according to R8 ECHA 2008 was used due to lack of experimental data on dermal penetration rate |
Modified dose-descriptor |
NOAEL corrected dermal = 65.4 * 1 = 65.4 mg/kg bw/d |
|
Step 3) Assessment factors |
|
|
Allometric scaling |
1 |
Substance specific assessment factor: Adverse effects observed were unspecific general effects such as clinical signs, impaired body weights and changes in urine, predominantly as secondary consequence of reduced water and food consumption. The intensive taste and odor of the test substance solutions used is likely to be the cause of the major adverse effects observed after oral application. These findings are not expected to depend on a systemic toxic parent compound/metabolite being excreted dependent of caloric demand. Therefore, use of AF >1 for allometric scaling is not considered necessary based on the nature of effects observed. |
Remaining differences |
1 |
Substance specific assessment factor: Besides unspecific general effects such as clinical signs, impaired body weights and changes in urine, predominantly as secondary consequence of reduced water and food consumption, no specific test substance related organ toxicity has been observed. The intensive taste and odor of the test substance solutions used is likely to be the cause of the major adverse effects observed after oral application. On the basis of these findings, no toxicodynamic and/or additional toxicokinetic differences between test animals and humans is to be expected. Overall, no additional AF for remaining differences is considered mandatory. |
Intraspecies |
10 |
Default assessment factor according to R8 ECHA 2008 was used as worst case to cover uncertainties due to the read across made. |
Exposure duration |
2 |
Use of a subchronic study as starting point forlong-term systemic DNEL derivation (default assessment factor according to R8 ECHA 2008) |
Dose response |
1 |
according to R8 ECHA 2008 |
Quality of database |
1 |
according to R8 ECHA 2008 (GLP guideline Study) |
DNEL |
Value |
|
|
65.4 / (1 x 1 x 10 x 2 x 1 x 1) = 3.27 mg/kg bw/day |
For derivation of the long-term systemic oral DNELof prenyl acetate,the NOAEL 65.4 mg/kg bw/d was used. After applying the assessment factors, the oral long-term systemic DNEL was set at 3.27 mg/ kg bw/day for the general population.
Long-term – oral, systemic effects
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 65.4 mg/kg bw/day |
|
Step 2) Modification of starting point |
- |
- |
Step 3) Assessment factors |
|
|
Allometric scaling |
1 |
Substance specific assessment factor: Adverse effects observed were unspecific general effects such as clinical signs, impaired body weights and changes in urine, predominantly as secondary consequence of reduced water and food consumption. The intensive taste and odor of the test substance solutions used is likely to be the cause of the major adverse effects observed after oral application. These findings are not expected to depend on a systemic toxic parent compound/metabolite being excreted dependent of caloric demand. Therefore, use of AF >1 for allometric scaling is not considered necessary based on the nature of effects observed. |
Remaining differences |
1 |
Substance specific assessment factor: Besides unspecific general effects such as clinical signs, impaired body weights and changes in urine, predominantly as secondary consequence of reduced water and food consumption, no specific test substance related organ toxicity has been observed. The intensive taste and odor of the test substance solutions used is likely to be the cause of the major adverse effects observed after oral application. On the basis of these findings, no toxicodynamic and/or additional toxicokinetic differences between test animals and humans is to be expected. Overall, no additional AF for remaining differences is considered mandatory. |
Intraspecies |
10 |
Default assessment factor according to R8 ECHA 2008 was used as worst case to cover uncertainties due to the read across made. |
Exposure duration |
2 |
use of a subchronic study as starting point forlong-term systemic DNEL derivation (default assessment factor according to R8 ECHA 2008) |
Dose response |
1 |
according to R8 ECHA 2008 |
Quality of database |
1 |
according to R8 ECHA 2008 (GLP guideline Study) |
DNEL |
Value |
|
|
65.4 / (1 x 1 x 10 x 2 x 1 x 1) = 3.27 mg/kg bw/day |
No DNELs were derived for local effects after short term or after long term inhalative exposure, as the substance exhibits no hazardous potential in terms of these endpoints and the conservatively derived long term inhalative DNEL for systemic effects covers putative local effects. No DNELs were derived for systemic effects after short term oral, dermal or inhalative exposure, as the substance exhibits no hazardous potential in terms of these endpoints and the conservatively derived respective long term DNELs for systemic effects sufficiently covers such putative effects.
No DNEL for local effects after short term/ long term dermal exposure was derived. Data for skin sensitization identify prenyl acetat as not skin sensiziting in a weight of evidence and do not fulfill the respective classification and labeling criteria. Furtherrmore prenyl acetate was found to be not irritating to skin.
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