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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.73 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 500
Dose descriptor starting point:
LOAEL
Value:
62.5 mg/m³
Modified dose descriptor starting point:
LOAEC
Value:
1 102 mg/m³
Explanation for the modification of the dose descriptor starting point:

No study available; DNEL derived from Screening for Reproductive and Developmental dose toxicity, oral, using ECHA Guidance on information requirements and chemical safety assessment R.8 (December, 2010 Version 2)
AF for dose response relationship:
5
Justification:
No effects at the dose descriptor starting point seen in a 28 days repeated dose toxicity study where a NOAEL of 150 mg/kg bw/day has been established. The LOAEL (of 62.5 mg/kgbw/day) is obtained from a Screening study on Reproductive and Developmental Toxicity. A Full study on Developmental toxicity is available and does not show any effects up to 1000 mg/kg bw/day.
AF for differences in duration of exposure:
6
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for interspecies differences (allometric scaling):
4
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for other interspecies differences:
2.5
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for intraspecies differences:
5
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for the quality of the whole database:
1
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.42 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 500
Dose descriptor starting point:
LOAEL
Value:
62.5 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
625 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No study available; DNEL derived from Screening for Reproductive and Developmental dose toxicity, oral, using ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for dose response relationship:
5
Justification:
No effects seen in a 28 days repeated dose toxicity study were a NOAEL of 150 mg/kg bw/day has been established. The LOAEL is obtained from a Screening study, therefore this value is taken until a full study is available.
AF for differences in duration of exposure:
6
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for interspecies differences (allometric scaling):
4
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for other interspecies differences:
2.5
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for intraspecies differences:
5
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for the quality of the whole database:
1
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low 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:
0.18 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3 000
Dose descriptor starting point:
LOAEL
Value:
62.5 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
543.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
No study available; DNEL derived from Screening for Reproductive and Developmental dose toxicity, oral, using ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for dose response relationship:
5
Justification:
No effects seen in a 28 days repeated dose toxicity study were a NOAEL of 150 mg/kg bw/day has been established. The LOAED is obtained from a Screening study, therefore this value is taken until a full study is available.
AF for differences in duration of exposure:
6
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for interspecies differences (allometric scaling):
4
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for other interspecies differences:
2.5
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for intraspecies differences:
10
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for the quality of the whole database:
1
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.21 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3 000
Dose descriptor starting point:
LOAEL
Value:
62.5 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
625 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No study available; DNEL derived from Screening for Reproductive and Developmental dose toxicity, oral, using ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for dose response relationship:
5
Justification:
No effects seen in a 28 days repeated dose toxicity study were a NOAEL of 150 mg/kg bw/day has been established. The LOAED is obtained from a Screening study, therefore this value is taken until a full study is available.
AF for differences in duration of exposure:
6
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for interspecies differences (allometric scaling):
4
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for other interspecies differences:
2.5
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for intraspecies differences:
10
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for the quality of the whole database:
1
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low 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:
0.02 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3 000
Dose descriptor starting point:
LOAEL
Value:
62.5 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
62.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no route-to-route justification needed
AF for dose response relationship:
5
Justification:
No effects seen in a 28 days repeated dose toxicity study were a NOAEL of 150 mg/kg bw/day has been established. The LOAED is obtained from a Screening study, therefore this value is taken until a full study is available.
AF for differences in duration of exposure:
6
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for interspecies differences (allometric scaling):
4
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for other interspecies differences:
2.5
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for intraspecies differences:
10
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for the quality of the whole database:
1
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
AF for remaining uncertainties:
1
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment R.8 (November, 2012 Version 2.1)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population