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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
17.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Value:
528 mg/m³
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
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:
2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Acute/short term exposure
DNEL related information

Local effects

Long 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

DNEL Workers

 

DNEL Long-term - inhalation, systemic effects

 

Relevant dose descriptor for the endpoint concerned: NOAEL of 300 mg/kg bw/day in rats in chronic oral toxicity study

 

Correction of starting point:

Differences in respiratory volumes: respiratory volume of the rat in 8 h corresponds to 0.38 m3/kg bw, additional correction for the higher standard respiratory volumes of workers compared to resting persons: correction factor = (1 ÷ 0.38) * (6.7 ÷ 10) = 1.76

Overall correction factor: 1.76

Corrected starting point: 300 * 1.76 = 528 mg/m3

 

Assessment factors relating to the extrapolation procedure:

Interspecies: not considered, as an allometric scaling is not applied in the case of systemic effects after inhalation

Intraspecies: 5 (default assessment factor)

Time extrapolation: 1 (default assessment factor)

Route to route extrapolation: 2 (default assessment factor)

Dose-response: 1 (default assessment factor)

Quality of whole database: 3 (older study, not all standard endpoints investigated)

Overall assessment factor: 5 * 1 * 2 * 1 * 3 = 30

 

DNEL Long-term - inhalation, systemic effects: 528 mg/m3 ÷ 30 = 17.6 mg/m3

 

 

DNEL Long-term - dermal, systemic effects

 

Relevant dose descriptor for the endpoint concerned: NOAEL of 300 mg/kg bw/day in rats in chronic oral toxicity study

 

Assessment factors relating to the extrapolation procedure:

Interspecies: 4 * 2.5 (default assessment factors)

Intraspecies: 5 (default assessment factor)

Time extrapolation: 1 (default assessment factor)

Route to route extrapolation: 1 (default assessment factor)

Dose-response: 1 (default assessment factor)

Quality of whole database: 3 (older study, not all standard endpoints investigated)

Overall assessment factor: 4 * 2.5 * 5 * 1 * 1 * 1 * 3 = 150

 

DNEL Long-term - dermal, systemic effects: 300 mg/kg bw/day ÷ 150 = 2 mg/kg bw/day

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEC
Value:
261 mg/m³
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

DNEL General Population

 

DNEL Long-term - inhalation, systemic effects

 

Relevant dose descriptor for the endpoint concerned: NOAEL of 300 mg/kg bw/day in rats in chronic oral toxicity study

 

Correction of starting point:

Differences in respiratory volumes: respiratory volume of the rat in 24 h corresponds to 1.15 m3/kg bw, correction factor 1 ÷ 1.15 = 0.87

Overall correction factor: 0.87

Corrected starting point: 300 * 0.87 = 261 mg/m3

 

Assessment factors relating to the extrapolation procedure:

Interspecies: not considered, as an allometric scaling is not applied in the case of systemic effects after inhalation

Intraspecies: 10 (default assessment factor)

Time extrapolation: 1 (default assessment factor)

Route to route extrapolation: 2 (default assessment factor)

Dose-response: 1 (default assessment factor)

Quality of whole database: 3 (older study, not all standard endpoints investigated)

Overall assessment factor: 10 * 1 * 2 * 1 * 3 = 60

 

DNEL Long-term - inhalation, systemic effects: 261 mg/m3 ÷ 60 = 4.4 mg/m3

 

 

DNEL Long-term - dermal, systemic effects

 

Relevant dose descriptor for the endpoint concerned: NOAEL of 300 mg/kg bw/day in rats in chronic oral toxicity study

 

Assessment factors relating to the extrapolation procedure:

Interspecies: 4 * 2.5 (default assessment factors)

Intraspecies: 10 (default assessment factor)

Time extrapolation: 1 (default assessment factor)

Route to route extrapolation: 1 (default assessment factor)

Dose-response: 1 (default assessment factor)

Quality of whole database: 3 (older study, not all standard endpoints investigated)

Overall assessment factor: 4 * 2.5 * 10 * 1 * 1 * 1 * 3 = 300

 

DNEL Long-term - dermal, systemic effects: 300 mg/kg bw/day ÷ 300 = 1 mg/kg bw/day

 

 

DNEL Long-term - oral, systemic effects

 

Relevant dose descriptor for the endpoint concerned: NOAEL of 300 mg/kg bw/day in rats in chronic oral toxicity study

 

Assessment factors relating to the extrapolation procedure:

Interspecies: 4 * 2.5 (default assessment factors)

Intraspecies: 10 (default assessment factor)

Time extrapolation: 1 (default assessment factor)

Route to route extrapolation: not considered, as same route

Dose-response: 1 (default assessment factor)

Quality of whole database: 3 (older study, not all standard endpoints investigated)

Overall assessment factor: 4 * 2.5 * 10 * 1 * 1 * 3 = 300

 

DNEL Long-term - oral, systemic effects: 300 mg/kg bw/day ÷ 300 = 1 mg/kg bw/day