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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3.5 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):
25
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
88 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification of the starting point (R.8 Figure R.8 -3):

Corrected inhalatory N(L)OAEC = oral N(L)OAEL*(1/sRVrat)*ABSoral-rat/ABSinh-human)*(sRVhuman/wRV)

= oral N(L)OAL*(1/0.38 m3/kg/d)*(1/1)*6.7m3(8h)/10 m3 (8h))

ABS: Absoprtion

sRV: standard Respiratory Volume

wRV: worker Respiratory Volume

ABSoral-rat: 1 [-]: worst case default

ABSinh-human: 1 [-]: worst case default

AF for dose response relationship:
1
Justification:
No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic: REACH guidance R.8 (default)
Justification:
Not relevant for corrected inhalation DNEL: REACH guidance R.8 (default)
AF for other interspecies differences:
2.5
Justification:
Interspecies remaining differences: REACH guidance R.8 (default)
AF for intraspecies differences:
5
Justification:
Worker: REACH guidance R.8 (default)
Justification:
No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
AF for remaining uncertainties:
1
Justification:
No remaining 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:
1 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):
100
Dose descriptor starting point:
NOAEL
Value:
50 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:

The substance is four times more acutely toxic via the oral than via the dermal route. Therefore, a factor of 0.5 is used for route-to-route extrapolation.

AF for dose response relationship:
1
Justification:
No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic: REACH guidance R.8 (default)
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to Human: REACH guidance R.8 (default)
AF for other interspecies differences:
2.5
Justification:
Interspecies remaining differences: REACH guidance R.8 (default)
AF for intraspecies differences:
5
Justification:
Worker: REACH guidance R.8 (default)
AF for the quality of the whole database:
1
Justification:
No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
AF for remaining uncertainties:
1
Justification:
No remaining 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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

1. Identification of relevant dose descriptor

In an OECD 408 study performed in rats, the substance did not cause mortalities. Gait ataxia in males and effects on kidney as well as crystal formation in urine in males and females was observed after subchronic administration at the highest concentration of 300 mg/kg bw. The NOAEL is considered to be 50 mg/kg bw/d.

2. Mode of action

No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.

3. Dermal absorption

Calculation of DNEL based upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, may 2008

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.9 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):
50
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
43.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

Corrected inhalatory N(L)OAEC = oral N(L)OAEL*(1/sRVrat)*ABSoral-rat/ABSinh-human)

= oral N(L)OAL*(1/1.15 m3/kg/d)*(1/1)

ABS: Absoprtion

sRV: standard Respiratory Volume

ABSoral-rat: 1 [-]: worst case default

ABSinh-human: 1 [-]: worst case default

AF for dose response relationship:
1
Justification:
No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic: REACH guidance R.8 (default)
Justification:
Not relevant for corrected inhalation DNEL: REACH guidance R.8 (default)
AF for other interspecies differences:
2.5
Justification:
Interspecies remaining differences: REACH guidance R.8 (default)
AF for intraspecies differences:
10
Justification:
General population: REACH guidance R.8 (default)
AF for the quality of the whole database:
1
Justification:
No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
50 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:

The substance is four times more acutely toxic via the oral than via the dermal route. Therefore, a factor of 0.5 is used for route-to-route extrapolation.

AF for dose response relationship:
1
Justification:
No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic: REACH guidance R.8 (default)
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to Human: REACH guidance R.8 (default)
AF for other interspecies differences:
2.5
Justification:
Interspecies remaining differences: REACH guidance R.8 (default)
AF for intraspecies differences:
10
Justification:
General population: REACH guidance R.8 (default)
AF for the quality of the whole database:
1
Justification:
No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
AF for remaining uncertainties:
1
Justification:
No remaining 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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 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):
200
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No data on absorption in the rat and in humans is available, therefore the dose descriptor starting point could not be corrected.

AF for dose response relationship:
1
Justification:
No issues in relevance or reliability of dose response: REACH guidance R.8 (default)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic: REACH guidance R.8 (default)
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to Human: REACH guidance R.8 (default)
AF for other interspecies differences:
2.5
Justification:
Interspecies remaining differences: REACH guidance R.8 (default)
AF for intraspecies differences:
10
Justification:
General population: REACH guidance R.8 (default)
AF for the quality of the whole database:
1
Justification:
No significant reduction in relevance or reliability across the database: REACH guidance R.8 (default)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
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

1. Identification of relevant dose descriptor

In an OECD 408 study performed in rats, the substance did not cause mortalities. Gait ataxia in males and effects on kidney as well as crystal formation in urine in males and females was observed after subchronic administration at the highest concentration of 300 mg/kg bw. The NOAEL is considered to be 50 mg/kg bw/d.

2. Mode of action

No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.

3. Dermal absorption

Calculation of DNEL based upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, May 2008