Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

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

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
1 027 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor:
other: EC3 value
AF for dose response relationship:
3
Justification:
Human exposure is expected in a matrix with no penetration enhancers or irritants.
AF for interspecies differences (allometric scaling):
1
Justification:
Sensitisation is a local immunological effect with a similar mechanism across mammalian species.
AF for intraspecies differences:
5
Justification:
Default value for workers because no difference in sensitisation potential is expected between workers and consumers.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 027 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor starting point:
other: EC3 value
AF for dose response relationship:
3
Justification:
Human exposure is expected in a matrix with no penetration enhancers or irritants.
AF for other interspecies differences:
1
Justification:
Sensitisation is a local immunological effect with a similar mechanism across mammalian species.
AF for intraspecies differences:
5
Justification:
Default value for workers because no difference in sensitisation potential is expected between workers and consumers.

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) and oral administration of test item to rats by gavage, at dose levels of 250, 500 and 750 mg/kg bw/day, was well tolerated in a 90-day repeated dose oral toxicity study (NOAEL 750 mg/kg bw/day). No evidence of skin irritation/corrosion or serious eye damage/irritation was identified but the substance is classified as a skin sensitiser (1B) and appropriate local DNELs have been derived.

General Population - Hazard via inhalation route

Systemic effects

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

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
1 027 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor:
other: EC3 value
AF for dose response relationship:
3
Justification:
Human exposure is expected in a matrix with no penetration enhancers or irritants.
AF for interspecies differences (allometric scaling):
1
Justification:
Sensitisation is a local immunological effect with a similar mechanism across mammalian species.
AF for intraspecies differences:
5
Justification:
Default value for workers because no difference in sensitisation potential is expected between workers and consumers.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 027 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor starting point:
other: EC3 value
AF for dose response relationship:
3
Justification:
Human exposure is expected in a matrix with no penetration enhancers or irritants.
AF for interspecies differences (allometric scaling):
1
Justification:
Sensitisation is a local immunological effect with a similar mechanism across mammalian species.
AF for intraspecies differences:
5
Justification:
Default value for workers because no difference in sensitisation potential is expected between workers and consumers.

General Population - Hazard via oral route

Systemic effects

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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) and oral administration of test item to rats by gavage, at dose levels of 250, 500 and 750 mg/kg bw/day, was well tolerated in a 90-day repeated dose oral toxicity study (NOAEL 750 mg/kg bw/day). No evidence of skin irritation/corrosion or serious eye damage/irritation was identified but the substance is classified as a skin sensitiser (1B) and appropriate local DNELs have been derived.