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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
10.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
500 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
251.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

No route extrapolation required. 251 mg/m³ represents the corrected worker NOAEC, derived according Guidance R8 from the NOAEC of 500 mg/m³ observed in a subchronic rat inhalation study.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The susbtance is classified acute toxicity 3 H331. The susbtance is classified acute toxicity 3 by inhalation and is corrosive : it is therefore in the high hazard band according to ECHA Guidance on information requirements and chemical safety assessement Part E, table E3 -1

Local effects

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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.43 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
500 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
142.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEC (90d inh., rat) = 500 mg/m3 for systemic effects: corresponding to a dose in rat of NOAEC(inhal.) x0.38 m3/(kg*d) = 190 mg/(kg*d); adjustment to long-term exposure in animals (*1/2) and worker´s conditions: 190 mg/(kg*d) * 1/(4 x 5 x 2) = 1.92 mg/(kg*d) ((including the allometric scaling factor of 1/4 and intraspecies factor for workers of 1/5), remaining intraspecies AS 2.5). It is assumed that absorption via skin is identical to absorption via inhalation.  

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The susbtance is corrosive and is therefore in the high hazard band according to ECHA guidance on information requirements.

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Explanation for the modification of the dose descriptor starting point:

This scenarii is not relevant for the general population.

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Acute short-term exposure of the general population is not expected according to the exposure scenarii.

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
DNEL related information
Justification:
Default (DNEL calculator)
Justification:
Default (DNEL calculator)
Justification:
Default (DNEL calculator)
Justification:
Default (DNEL calculator)
Justification:
Default (DNEL calculator)
Justification:
Default (DNEL calculator)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Acute short-term exposure of the general population is not expected according to the exposure scenarii.

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
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Justification:
Default (DNEL calculator)
Justification:
Default (DNEL calculator)
Justification:
Default (DNEL calculator)
Justification:
Default (DNEL calculator)
Justification:
Default (DNEL calculator)
Justification:
Default (DNEL calculator)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Acute short-term exposure of the general population is not expected according to the exposure scenarii.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population