Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Dose descriptor:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.67 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
other: Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23
Overall assessment factor (AF):
300
Dose descriptor:
other: EC3 value of 26.1% of LLNA study, calculated as area dose 6.5 mg/cm2 according to ECHA Guidance on information requirements and CSA
Value:
6.5 mg/m³
AF for dose response relationship:
1
Justification:
not applicable
AF for differences in duration of exposure:
1
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable
AF for other interspecies differences:
1
Justification:
not applicable
AF for intraspecies differences:
10
Justification:
according to Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23
AF for the quality of the whole database:
1
Justification:
not applicable
AF for remaining uncertainties:
30
Justification:
specific AF of 3 for Matrix effects and another AF of 10 for use cosniderations as proposed by Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.67 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
other: Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23
Overall assessment factor (AF):
300
Dose descriptor starting point:
other: EC3 value of 26.1% of LLNA study, calculated as area dose 6.5 mg/cm2 according to ECHA Guidance on information requirements and CSA
Value:
6.5 mg/m³
AF for dose response relationship:
1
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable
AF for other interspecies differences:
1
Justification:
not applicable
AF for intraspecies differences:
10
Justification:
according to Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23
AF for the quality of the whole database:
1
Justification:
not applicable
AF for remaining uncertainties:
30
Justification:
specific AF of 3 for Matrix effects and another AF of 10 for use considerations as proposed by Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Dose descriptor:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.67 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
other: Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23
Overall assessment factor (AF):
300
Dose descriptor:
other: EC3 value of 26.1% of LLNA study, calculated as area dose 6.5 mg/cm2 according to ECHA Guidance on information requirements and CSA
Value:
6.5 mg/m³
AF for dose response relationship:
1
Justification:
not applicable
AF for differences in duration of exposure:
1
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable
AF for other interspecies differences:
1
Justification:
not applicable
AF for intraspecies differences:
10
Justification:
according to Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23
AF for the quality of the whole database:
1
Justification:
not applicable
AF for remaining uncertainties:
30
Justification:
specific AF of 3 for Matrix effects and another AF of 10 for use considerations as proposed by Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.67 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
other: Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23
Overall assessment factor (AF):
300
Dose descriptor starting point:
other: EC3 value of 26.1% of LLNA study, calculated as area dose 6.5 mg/cm2 according to ECHA Guidance on information requirements and CSA
Value:
6.5 mg/m³
AF for dose response relationship:
1
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
not applicable
AF for other interspecies differences:
1
Justification:
not applicable
AF for intraspecies differences:
10
Justification:
according to Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23
AF for the quality of the whole database:
1
Justification:
not appicable
AF for remaining uncertainties:
30
Justification:
specific AF of 3 for Matrix effects and another AF of 10 for use considerations as proposed by Api et. al, 2008, Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients, Regulatory Toxicology and Pharmacology 52 (2008) 3–23

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information
DNEL derivation method:
other: not applicable, see "justification and comments"
Modified dose descriptor starting point:
other: not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"
Justification:
not applicable, see "justification and comments"

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population