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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
DNEL related information
DNEL derivation method:
other: ECHA Guidance. Generic ECHA recommendation for a long-term DNEL (inhalation, worker)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.359 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):
300
Dose descriptor starting point:
NOAEL
Value:
107.7 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
107.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modification of dose descriptor:

 

Converted oral NOAEL rat (in mg/kg bw/day) into dermal NOAEL rat (in mg/kg bw/day) by correcting for differences in absorption between routes as well as for differences in dermal absorption between rats and humans:

 

 

corrected dermal NOAEL = oral NOAEL x (ABSoral-rat/ ABSderm-rat) x (ABSderm-rat/ ABSderm-human)

 

                                     = oral NOAEL x (ABSoral-rat/ ABSderm-human)

 

                                      = 107.7 mg/Kg bw/day x (1 / 1) 

 

Note: Dermal absorption assumed not be higher than oral absorption, therefore no default factor (i.e. factor 1) introduced when performing oral-to-dermal extrapolation(ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).

AF for dose response relationship:
1
Justification:
Default assessment factor when the starting point for the DNEL calculation is a NOAEL (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for differences in duration of exposure:
6
Justification:
Default assessment factor of 6 applied when extrapolating duration of exposure from sub-acute to chronic (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling factor for rats compared to humans (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences; systemic effects (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for intraspecies differences:
5
Justification:
For workers, as standard procedure for threshold effects, a default assessment factor of 5 was applied (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for the quality of the whole database:
1
Justification:
Default assessment factor applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

Acute toxicity:

ECHA Guidance R.8 (Chapter R.8.1.2.5) indicates that DNELs for acute toxicity are not established if no acute toxicity hazard leading to classification has been identified.

 

Irritation/Sensitisation:

Rosin amine 90 is classified as eye damage cat/1 and skin senstiser, cat 1A. This general qualitative CSA approach has been applied including the implementation of risk management measures (RMMs) and operational conditions (OCs).

 

Repeated dose toxicity:

The NOAEL value used for the derivation of the DNEL comes from the read-across study in rats performed according to the OECD TG 422 on Gum Rosin, CAS# 8050-09-7 (Harlan, 2014).

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
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.179 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):
600
Dose descriptor starting point:
NOAEL
Value:
107.7 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
107.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modification of dose descriptor:

 

Converted oral NOAEL rat (in mg/kg bw/day) into dermal NOAEL rat (in mg/kg bw/day) by correcting for differences in absorption between routes as well as for differences in dermal absorption between rats and humans:

 

 

corrected dermal NOAEL = oral NOAEL x (ABSoral-rat/ ABSderm-rat) x (ABSderm-rat/ ABSderm-human)

 

                                     = oral NOAEL x (ABSoral-rat/ ABSderm-human)

 

                                      = 107.7 mg/Kg bw/day x (1 / 1) 

 

Note: Dermal absorption assumed not be higher than oral absorption, therefore no default factor (i.e. factor 1) introduced when performing oral-to-dermal extrapolation(ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).

AF for dose response relationship:
1
Justification:
Default assessment factor when the starting point for the DNEL calculation is a NOAEL (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for differences in duration of exposure:
6
Justification:
Default assessment factor of 6 applied when extrapolating duration of exposure from sub-acute to chronic (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling factor for rats compared to humans (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences; systemic effects (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for intraspecies differences:
10
Justification:
For general population, as standard procedure for threshold effects, a default assessment factor of 10 was applied (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for the quality of the whole database:
1
Justification:
Default assessment factor applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.179 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):
600
Dose descriptor starting point:
NOAEL
Value:
107.7 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default assessment factor when the starting point for the DNEL calculation is a NOAEL (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for differences in duration of exposure:
6
Justification:
Default assessment factor of 6 applied when extrapolating duration of exposure from sub-acute to chronic (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling factor for rats compared to humans (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences; systemic effects (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for intraspecies differences:
10
Justification:
For workers, as standard procedure for threshold effects, a default assessment factor of 5 was applied (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
AF for the quality of the whole database:
1
Justification:
Default assessment factor applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements (ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, Version 2.1, November 2012).
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.179 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEL
Value:
107.7 mg/kg bw/day

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

Acute toxicity:

ECHA Guidance R.8 (Chapter R.8.1.2.5) indicates that DNELs for acute toxicity are not established if no acute toxicity hazard leading to classification has been identified.

 

Irritation/Sensitisation:

Rosin amine 90 is classified as eye damage cat/1 and skin sensitiser, cat 1A. This general qualitative CSA approach has been applied including the implementation of risk management measures (RMMs) and operational conditions (OCs).

 

Repeated dose toxicity:

The NOAEL value used for the derivation of the DNEL comes from the read-across study in rats performed according to the OECD TG 422 on Gum Rosin, CAS# 8050-09-7 (Harlan, 2014).