Registration Dossier
Registration Dossier
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EC number: 915-657-7 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
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:
- 3.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 40 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Additional information - workers
The basic dose descriptor for dermal short-term (acute) exposure was taken from an acute dermal toxicity study with the closely related substance Resin 835 A (Reaction mass of Rosin, hydrogenated and [1R-(1a,4aß,10aa)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylic acid)in rats and an LD50 >2000 mg per kg body weight.
Basic dose descriptorforlong-term exposure: In an oral repeated dose toxicity study (gavage) with the closely related substance Resin 835 A in the rat the NOAEL was 316 mg per kg body weight for males and females. 316 mg/kg body weight is taken as the basic dose descriptor for long-term exposure.
No DNELs are derived for acute or long-term exposure via inhalation, as exposure via inhalation is not likely: The vapour pressure Is very low (in the range of 10E-11 Pa at 25 °C).
All references are made to the"Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health"
The assessment factors (AF) used are given in the following order:
Interspecies metabolic rate for the conversion of the results from rat to human: 4 (dermal, oral)
- Interspecies remaining differences: 2.5
- Intraspecies: 5
- Factor to cover the
ratio LD50/NOEL: 1
or to extrapolate from sub-chronic to chronic exposure: 2
- Dose response reliability: 1
- Quality of whole database: 1
as inRefTable R.8-6.
Acute – short-term exposure, systemic effects:
Dermal
Dose descriptor starting point:
LD50dermal,acute >2000 mg/kg bw.
Overall AF= 4*2.5*5*1*1*1 = 50.
As no toxic signs were noted at the LD50,dermal the LD50,dermal is considered to be also the NOAEL,dermal. A factor of 1 is therefore applied to cover the ratio LD50/NOAEL.
Long-term exposure, systemic effects:
Dermal
Dose descriptor starting point:
NOELdermal = NOELoral,90d = 316 mg/kg bw.
The dermal absorption is considered to be generally lower as the oral absorption. As a worst case it is therefore assumed that the NOELdermal = NOELoral.
Overall AF= 4*2.5*5*2*1*1 = 100.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.35 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- 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:
- 0.35 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.3 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- LOAEL
General Population - Hazard for the eyes
Additional information - General Population
The basic dose descriptor for dermal short-term (acute) exposure was taken from an acute dermal toxicity study with the closely related substance Resin 835 A (Reaction mass of Rosin, hydrogenated and [1R-(1a,4aß,10aa)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylic acid)in rats and an LD50 >2000 mg per kg body weight.
The basic dose descriptor for oral short-term (acute) exposure was taken from an acute oral toxicity study with the closely related substance Dresinate 835 A (sodium salt) in rats and an LD50 >2000 mg per kg body weight. The LD0 was 1600 mg/kg body weight, signs of toxicity were observed also at 1600 mg/kg bw.
Basic dose descriptor for long-term exposure: In an oral repeated dose toxicity study (gavage) wirh Resin 835 A in the rat the NOAEL was 316 mg per kg body weight for males and females. In a reproduction/developmental toxicity screening test with the closely related substance rosin no effects on fertility and reproduction were seen at 208 to 352 mg per kg body weight. The NOAEL for the parental generation was between 71 and 109 mg per kg body weight and only marginal effects were seen at 208 to 352 mg per kg body weight in this study. A NOAEL of 208 mg per kg body weight is therefore taken as the basic dose descriptor.
No DNELs are derived for acute or long-term exposure via inhalation, as exposure via inhalation is not likely: The vapour pressure Is very low (in the range of 10E-11 Pa at 25 °C).
All references are made to the"Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health"
The assessment factors (AF) used are given in the following order:
Interspecies metabolic rate for the conversion of the results from rat to human: 4 (dermal, oral) or 1 (for inhalation)
- Interspecies remaining differences: 2.5
- Intraspecies: 10
- Factor to cover the
ratio LD50/NOEL: 1 or 3
or to extrapolate from the sub-acute to chronic exposure: 6
- Dose response reliability: 1
- Quality of whole database: 1
as inRefTable R.8-6.
Acute – short-term exposure, systemic effects:
Dermal
Dose descriptor starting point:
LD50dermal,acute >2000 mg/kg bw.
Overall AF= 4*2.5*10*1*1*1 = 100.
As no toxic signs were noted at the LD50,dermal the LD50,dermal is considered to be also the NOAEL,dermal. A factor of 1 is therefore applied to cover the ratio LD50/NOAEL.
Oral
Dose descriptor starting point:
LD0oral,acute 1600 mg/kg bw.
Overall AF= 4*2.5*10*3*1*1 = 300.
As signs of toxicity were noted at the LD0,oral a factor of 3 is applied to cover the ratio LD50/NOAEL.
Long-term exposure, systemic effects:
Dermal
Dose descriptor starting point:
NOELdermal = NOELreproduction/developmental toxicity screening test,oral = 208 mg/kg bw.
The dermal absorption is considered to be generally lower as the oral absorption. As a worst case it is therefore assumed that the NOELdermal = NOELoral.
Overall AF= 4*2.5*10*6*1*1 = 600.
Oral
NOELoral = NOELreproduction/developmental toxicity screening test,oral = 208 mg/kg bw.
Overall AF= 4*2.5*10*6*1*1 = 600.
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