Registration Dossier

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.