Registration Dossier
Registration Dossier
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EC number: 911-238-8 | 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
- 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:
- 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 hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The basic dose descriptor for dermal short-term (acute) exposure was taken from an acute dermal toxicity study with rats and an LD50 >2000 mg per kg body weight.
Basic dose descriptor for long-term exposure: In a 90-day oral repeated dose toxicity study (gavage) with Resin 835 A in the rat the NOAEL was 316 mg per kg body weight for males and females. In a Prenatal Developmental Toxicity Study the No Observed Adverse Effect Level (NOAEL) for maternal toxicity and fetal developmental toxicity was 250 mg/kg/day. Due to the longer exposure period the NOAEL of 316 mg per kg body weight determined in the sub-chronic study was taken as the basic dose descriptor. This is not conflicting with the lower NOAEL in the Prental Developmental Toxicity Study because there is no evidence for a higher sensitivity in this study.
No DNELs are derived for acute or long-term exposure via inhalation, as exposure via inhalation is not likely: No dust particles are generated and the vapour pressure Is very low (in the range of 10E-4 to 10E-5 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:
NOAELdermal = NOAELoral,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 NOAELdermal = NOAELoral.
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:
- 0.53 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
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:
- 0.53 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The basic dose descriptor for dermal short-term (acute) exposure was taken from an acute dermal toxicity study with 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 rats and an LD50 >2000 mg per kg body weight.
Basic dose descriptor for long-term exposure: In a 90-day oral repeated dose toxicity study (gavage) with Resin 835 A in the rat the NOAEL was 316 mg per kg body weight for males and females. In a Prenatal Developmental Toxicity Study the No Observed Adverse Effect Level (NOAEL) for maternal toxicity and fetal developmental toxicity was 250 mg/kg/day. Due to the longer exposure period the NOAEL of 316 mg per kg body weight determined in the sub-chronic study was taken as the basic dose descriptor. This is not conflicting with the lower NOAEL in the Prental Developmental Toxicity Study because there is no evidence for a higher sensitivity in this study.
No DNELs are derived for acute or long-term exposure via inhalation, as exposure via inhalation is not likely: No dust particles are generated and the vapour pressure Is very low (in the range of 10E-4 to 10E-5 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 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:
LD50oral,acute >2000 mg/kg bw.
Overall AF = 4*2.5*10*1*1*1 = 100.
As no toxic signs were noted at the LD50,oral the LD50,oral is considered to be also the NOAEL,oral. A factor of 1 is therefore applied to cover the ratio LD50/NOAEL.
Long-term exposure, systemic effects:
Dermal
Dose descriptor starting point:
NOAELdermal = NOAELoral,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 NOAELdermal = NOAELoral.
Overall AF = 4*2.5*10*6*1*1 = 600.
Oral
NOAELoral = NOAELoral,90d = 316 mg/kg bw.
Overall AF = 4*2.5*10*6*1*1 = 600.
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