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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
6.58 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):
75
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
493.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

Figure R.8-3 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)

AF for dose response relationship:
1
Justification:
Default assessment factor applied because starting point for DNEL calculation is a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on administration of test material to the rat for 28 days (subacute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required because differences in breathing between rat and human already accounted for during modification of starting point
AF for other interspecies differences:
2.5
Justification:
Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
AF for intraspecies differences:
5
Justification:
Default assessment factor for workers
AF for the quality of the whole database:
1
Justification:
The starting point NOAEL was obtained from a GLP guideline study
AF for remaining uncertainties:
1
Justification:
No other assessment factor is considered necessary
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:
DNEL (Derived No Effect Level)
Value:
9.33 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
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 800 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Example B.5 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)

AF for dose response relationship:
1
Justification:
Default assessment factor applied because starting point for DNEL calculation is a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on administration of test material to the rat for 28 days (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling to correct for differences in metabolic rate (rat to human)
AF for other interspecies differences:
2.5
Justification:
Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
AF for intraspecies differences:
5
Justification:
Default assessment factor for workers
AF for the quality of the whole database:
1
Justification:
The starting point NOAEL was obtained from a GLP guideline study
AF for remaining uncertainties:
1
Justification:
No other assessment factor is considered necessary
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:
512 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:
512 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, 400 and 1000 mg/kg bw/day, was well tolerated in a 28-day repeated dose oral toxicity study (NOAEL considered to be 1000 mg/kg bw/day for males and 400 mg/kg bw/day for females). 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 local DNEL that is equally applicable in the short term and the long term has been derived.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.16 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):
150
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
173.9 mg/m³
Explanation for the modification of the dose descriptor starting point:

Figure R.8-3 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)

AF for dose response relationship:
1
Justification:
Default assessment factor applied because starting point for DNEL calculation is a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on administration of test material to the rat for 28 days (subacute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required because differences in breathing between rat and human already accounted for during modification of starting point
AF for other interspecies differences:
2.5
Justification:
Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
AF for intraspecies differences:
10
Justification:
Default assessment factor for general population
AF for the quality of the whole database:
1
Justification:
The starting point NOAEL was obtained from a GLP guideline study
AF for remaining uncertainties:
1
Justification:
No other assessment factor is considered necessary
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:
DNEL (Derived No Effect Level)
Value:
3.33 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):
600
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Example B.5 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)

AF for dose response relationship:
1
Justification:
Default assessment factor applied because starting point for DNEL calculation is a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on administration of test material to the rat for 28 days (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling to correct for differences in metabolic rate (rat to human)
AF for other interspecies differences:
2.5
Justification:
Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
AF for intraspecies differences:
10
Justification:
Default assessment factor for general population
AF for the quality of the whole database:
1
Justification:
The starting point NOAEL was obtained from a GLP guideline study
AF for remaining uncertainties:
1
Justification:
No other assessment factor is considered necessary
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:
512 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:
512 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:
DNEL (Derived No Effect Level)
Value:
0.67 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):
600
Dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation not required

AF for dose response relationship:
1
Justification:
Default assessment factor applied because starting point for DNEL calculation is a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on administration of test material to the rat for 28 days (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling to correct for differences in metabolic rate (rat to human)
AF for other interspecies differences:
2.5
Justification:
Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
AF for intraspecies differences:
10
Justification:
Default assessment factor for general population
AF for the quality of the whole database:
1
Justification:
The starting point NOAEL was obtained from a GLP guideline study
AF for remaining uncertainties:
1
Justification:
No other assessment factor is considered necessary
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, 400 and 1000 mg/kg bw/day, was well tolerated in a 28-day repeated dose oral toxicity study (NOAEL considered to be 1000 mg/kg bw/day for males and 400 mg/kg bw/day for females). 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 local DNEL that is equally applicable in the short term and the long term has been derived.