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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
5.88 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):
30
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
176.32 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalation toxicity test is not available.
AF for dose response relationship:
1
Justification:
The initial value is NOAEL.
AF for differences in duration of exposure:
6
Justification:
The initial end-point is based on Reproduction/Developmental Toxicity Screening Test. Duration exposure in this test is 25-28 days, it means same period as sub-acute test.
AF for interspecies differences (allometric scaling):
1
Justification:
Corrected NOAEC was derived for human, it means that interspecies differences are included.
AF for other interspecies differences:
1
Justification:
There are not known any information shows specific susceptibility differences between species.
AF for intraspecies differences:
5
Justification:
DNEL is derived for workers.
AF for the quality of the whole database:
1
Justification:
Reliability of the original study is 1.
AF for remaining uncertainties:
1
Justification:
There are not known any information about other uncertainties.
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:
0.83 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):
120
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal toxicity test is not available.
AF for dose response relationship:
1
Justification:
The initial value is NOAEL.
AF for differences in duration of exposure:
6
Justification:
The initial end-point is based on Reproduction/Developmental Toxicity Screening Test. Duration exposure in this test is 25-28 days, it means same period as sub-acute test.
AF for interspecies differences (allometric scaling):
4
Justification:
The test was performed on rats.
AF for other interspecies differences:
1
Justification:
There are not known any information shows specific susceptibility differences between species.
AF for intraspecies differences:
5
Justification:
DNEL is derived for workers.
AF for the quality of the whole database:
1
Justification:
Reliability of the original study is 1.
AF for remaining uncertainties:
1
Justification:
There are not known any information about other uncertainties.
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:
61.28 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
105
Dose descriptor:
other: LOAEL
Value:
6 435 µg/m³
AF for dose response relationship:
3
Justification:
The initial value is LOAEL.
AF for differences in duration of exposure:
1
Justification:
The test time corresponds to the methodology.
AF for interspecies differences (allometric scaling):
7
Justification:
The skin sensitisation test (LLNA) was carried out on mice.
AF for other interspecies differences:
1
Justification:
There are not known any information shows specific susceptibility differences between species.
AF for intraspecies differences:
5
Justification:
DNEL is derived for workers.
AF for the quality of the whole database:
1
Justification:
Reliability of the original study is 1.
AF for remaining uncertainties:
1
Justification:
There are not known any information about other uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

DNEL for dermal and inhalation long-term systemic exposure was derived from Reproduction/Developmental Toxicity Screening Test according to Chapter R.8 Guidance on information requirements and chemical safety assessment. This NOAEL for male fertility seems to be the most sensitive end-point.

DNEL dermal long-term systemic exposure was derived on the basis of Skin sensitisation LLNA test from EC3 value according to Chapter R.8 Guidance on information requirements and chemical safety assessment.

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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

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

There are no uses for general population.