Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Based on EFSA Scientific Opinion, 2015 (EFSA Journal 2015, 13(1):3978) who established a temporary Tolerable Daily Intake.
Modified dose descriptor starting point:
BMDL10
Value:
8 960 µg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral to dermal route extrapolation is conducted based on a recent EFSA Scientific Opinion for the read-across substance 2,2-bis(4-hydroxyphenyl)propane (BPA, CAS 80-05-7; EFSA Journal 2015; 13(1): 3978). More detailed, with the background of detailed toxicokinetic information, EFSA used comprehensive PBPK modelling for the derivation of a dermal-to-oral route equivalence factor for BPA. This factor of 1.2, valid for male adults for occasional dermal exposure (not cosmetic uses), was used for the derivation of a dermal DNEL. With the use of this factor substance-specific toxicokinetic properties were taken into account and route to route extrapolation is justified.

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.3 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Based on EFSA Scientific Opinion, 2015 (EFSA Journal 2015, 13(1):3978) who established a temporary Tolerable Daily Intake.
Modified dose descriptor starting point:
BMDL10
Value:
8 960 µg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral to dermal route extrapolation is conducted based on a recent EFSA Scientific Opinion for the read-across substance 2,2-bis(4-hydroxyphenyl)propane (BPA, CAS 80-05-7; EFSA Journal 2015; 13(1): 3978). More detailed, with the background of detailed toxicokinetic information, EFSA uses comprehensive PBPK modelling for the derivation of a dermal-to-oral route equivalence factor for BPA. This factor of 1.2, valid for male adults for occasional dermal exposure (not cosmetic uses), was used for the derivation of a dermal DNEL. With the use of this factor substance-specific toxicokinetic properties were taken into account and route to route extrapolation is justified.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
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:
4 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Based on EFSA Scientific Opinion, 2015 (EFSA Journal 2015, 13(1):3978) who established a temporary Tolerable Daily Intake.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population