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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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:
86.7 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:
86.7 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.

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 100, 300 and 1000 mg/kg bw/day, was well tolerated in an OECD 422 combined 28-day repeated dose oral toxicity study with reproductive/developmental toxicity screening (NOAEL 1000 mg/kg bw/day), an OECD 414 investigation of developmental toxicity (NOAEL 1000 mg/kg bw/day) and a 90-day sub-chronic repeated dose oral toxicity study (OECD 408) at dose levels of 300, 600 and 1000 mg/kg bw/day (NOAEL 1000 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 an appropriate long-term local DNEL has 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:
86.7 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:
86.7 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 100, 300 and 1000 mg/kg bw/day, was well tolerated in an OECD 422 combined 28-day repeated dose oral toxicity study with reproductive/developmental toxicity screening (NOAEL 1000 mg/kg bw/day), an OECD 414 investigation of developmental toxicity (NOAEL 1000 mg/kg bw/day) and a 90-day sub-chronic repeated dose oral toxicity study (OECD 408) at dose levels of 300, 600 and 1000 mg/kg bw/day (NOAEL 1000 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 an appropriate long-term local DNEL has been derived.