Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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