Registration Dossier
Registration Dossier
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EC number: 932-164-2 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.05 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No long-term inhalation study is available for LE097 and NOAEC was derived from oral NOAEL. 8 h exposure time, extrapolation from 50% bioavailability oral to 100% bioavailability inhalation. Corrected inhalatory NOAEC = 200 mg/kg bw/day*(1/0.38 m3/kg/day)*(50%/100%)*(6.7 m3 (8h)/10 m3 (8h)) = 176.3 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not for concentrations
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- assumed that rat oral and dermal absorptions are equal to human oral and dermal absorption
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The long-term inhalation DNEL for systemic effects is derived from the subchronic (90-day) oral: gavage toxicity study conducted with the substance LE097 resulting in a NOAEL 200 mg/kg bw/day. Route-to-route (oral-inhalation) extrapolation was performed. The calculated DNEL is 7.05 mg/m³, applying the assessment factor of 25.
The acute/short term inhalation DNEL for systemic effects was not assessed based on 1.2 Weight of evidence chapter of Annex XI, Regulation (EC) 1907/2006. First of all, the substance exerts no systemic oral or dermal acute toxicity. In addition, LE097 has a low vapour pressure of 0.25 Pa at 25°C, which corresponds to 0.25 Pa / 101325 Pa x 10e6 ppm = 2.47 ppm saturated vapour pressure corresponding to 47 mg/m³ or 0.047 mg/L (with a molecular weight of ca. 461 g/mol). Thus an acute 4-hour inhalation study would either be carried out at 0.047 mg/L vapour or at the limit dose of 5 mg/L aerosol. Assuming a very conservative value of 100% bioavailability, a rat would receive a systemic dose of 0.8 L/min/kg x 240 min x 5 mg/L aerosol = 960 mg/kg. Since the acute oral and dermal LD50 were 2 times higher than calculated dose value for aerosol inhalation, it is considered unlikely that mortality would be observed in an acute inhalation study. Therefore the hazard was qualified to be not present.
The long-term and acute/short term inhalation DNEL for local effects was not assessed, since no quantitative NOAEL could be identified. Low hazard for this endpoint was suggested based on ECHA Practical Guide 15 and skin irritation study, where LE097 is classified as irritating substance of category 2.
The long-term dermal DNEL for systemic effects is derived also on the basis of the subchronic (90-day) oral: gavage toxicity study. For the route-to-route extrapolation it was assumed that oral and dermal absorption in the rat are equal to human oral and dermal absorption. The calculated DNEL is 2 mg/kg bw/day, applying the assessment factor of 100.
The acute/short term dermal DNEL for systemic effects was not assessed, since no quantitative NOAEL could be identified. The substance showed relatively low acute dermal toxicity (LD > 2000 mg/kg bw), therefore the hazard was qualified to be not present based on ECHA Practical Guide 15.
The long term and acute/short term dermal DNEL for local effects was not assessed, since no quantitative NOAEL could be identified. Low hazard for this endpoint was suggested based on ECHA Practical Guide 15 and skin irritation study, where LE097 is classified as irritating substance of category 2.
No hazard for the eyes was identified, since in a reliable eye irritation study (OECD TG 405) the substance LE097 is not irritating in rabbit eye.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.74 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- 24 h exposure time, extrapolation from 50% bioavailability oral to 100% bioavailability inhalation, since no inhalation study available. Corrected inhalatory NOAEC = 200 mg/kg bw/day*(1/1.15 m3/kg/day)*(50%/100%) = 87 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not for concentrations
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- assumed that rat oral and dermal absorptions are equal to human oral and dermal absorption
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not applicable
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The long-term inhalation DNEL for systemic effects is derived from the subchronic (90-day) oral: gavage toxicity study conducted with the substance LE097 resulting in a NOAEL 200 mg/kg bw/day. Route-to-route (oral-inhalation) extrapolation was performed. The calculated DNEL is 1.74 mg/m³, applying the assessment factor of 50.
The acute/short term inhalation DNEL for systemic effects was not assessed based on1.2 Weight of evidence chapter of Annex XI,Regulation (EC) 1907/2006. First of all, the substance exerts no systemic oral or dermal acute toxicity. In addition, LE097 has a low vapour pressure of 0.25 Pa at 25°C, which corresponds to 0.25 Pa / 101325 Pa x 10e6 ppm = 2.47 ppm saturated vapour pressure corresponding to 47 mg/m³ or 0.047 mg/L (with a molecular weight of ca. 461 g/mol). Thus an acute 4-hour inhalation study would either be carried out at 0.047 mg/L vapour or at the limit dose of 5 mg/L aerosol. Assuming a very conservative value of 100% bioavailability, a rat would receive a systemic dose of 0.8 L/min/kg x 240 min x 5 mg/L aerosol = 960 mg/kg.Since the acute oral and dermal LD50 were 2 times higher than calculated dose value for aerosol inhalation, it is considered unlikely that mortality would be observed in an acute inhalation study. Thereforethe hazard was qualified to be not present.
The long-term and acute/short term inhalation DNEL for local effects was not assessed, since no quantitative NOAEL could be identified. Low hazard for this endpoint was suggested based on ECHA Practical Guide 15 and skin irritation study, where LE097 is classified as irritating substance of category 2.
The long-term dermal DNEL for systemic effects is derived also on the basis of the subchronic (90-day) oral: gavage toxicity study. For the route-to-route extrapolation it was assumed that oral and dermal absorption in the rat are equal to human oral and dermal absorption. The calculated DNEL is 1 mg/kg bw/day, applying the assessment factor of 200.
The acute/short term dermal DNEL for systemic effects was not assessed, since no quantitative NOAEL could be identified. The substance showed relatively low acute dermal toxicity (LD > 2000 mg/kg bw), therefore the hazard was qualified to be not present based on ECHA Practical Guide 15.
The long term and acute/short term dermal DNEL for local effects was not assessed, since no quantitative NOAEL could be identified. Low hazard for this endpoint was suggested based on ECHA Practical Guide 15 and skin irritation study, where LE097 is classified as irritating substance of category 2.
The long-term oral DNEL for systemic effects is derived on the basis of the subchronic (90-day) oral: gavage toxicity study. The calculated DNEL is 1 mg/kg bw/day, applying the assessment factor of 200.
The acute/short term oral DNEL for systemic effects was not assessed, since no quantitative NOAEL could be identified. The substance showed relatively low acute orla toxicity (LD > 2000 mg/kg bw), therefore the hazard was qualified to be not present based on ECHA Practical Guide 15.
No hazard for the eyes was identified, since in a reliable eye irritation study (OECD TG 405) the substance LE097 is not irritating in rabbit eye.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
