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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.43 µg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
900
Dose descriptor starting point:
LOAEC
Value:
13.3 mg/m³
Modified dose descriptor starting point:
LOAEC
Value:
6.68 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point was derived from a 28-day inhalation study, where rats were exposed for 6 h/day and 5 days/week. No NOAEC was determined as adverse effects were seen at the lowest dose tested. LOAEC: 13.3 mg/m³ was therefore used as starting point.


Considering that the days of exposure per week (5/7) are the same as workers no correction was applied. A scaling factor was applied instead in order to consider the daily hours of exposure of rats in the study (6 h) and worker (8h). In addition, respiratory rate during working acitivty is higher than the standard, therefore a further correction has to be applied according to ECHA guidance R.8, table R. 8-2:


LOAECcorrected = 13.3 mg/m3 x 6/8 x 6.7/10 = 6.68 mg/m3

AF for dose response relationship:
3
Justification:
A NOAEC is not available. Considering the adverse effects observed at 13.3 mg/m3 an assessment factor of 3 is considered as appropriate
AF for differences in duration of exposure:
6
Justification:
Data extrapolated from a sub-acute study
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling for rats to human
AF for other interspecies differences:
2.5
Justification:
To account for remainig interspecies difference
AF for intraspecies differences:
5
Justification:
To account for general variability between workers
AF for the quality of the whole database:
1
Justification:
Guideline study
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
46 µg/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:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
14 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A 28 days dermal study is available but was disregarded due to major methodology deficiencies. A 28 days study via oral route was therefore used to calculate DNEL dermal.


The study was carried out on rats and the NOAEL value found under test conditions was 5 mg/kg bw.


A scaling factors of 1.4 to account for days of exposure animals/workers (7 versus 5) was considered. In addition, to account for a route to route extrapolation, an assessment factor of 2 was applied as dermal adsorption is considered 50% of the oral one. 


NOAELcorrected = 5 mg/kg bw x 1.4 x 2 = 14 mg/kg bw

AF for dose response relationship:
1
Justification:
NOAEL value available
AF for differences in duration of exposure:
6
Justification:
From sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
From rats to human
AF for other interspecies differences:
2.5
Justification:
for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
for variability between workers
AF for the quality of the whole database:
1
Justification:
guideline study
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low 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:
1.32 µg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 800
Dose descriptor starting point:
LOAEC
Value:
13.3 mg/m³
Modified dose descriptor starting point:
LOAEC
Value:
2.37 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point was derived from a 28-day inhalation study, where rats were exposed for 6 h/day and 5 days/week. No NOAEC was determined as adverse effects were seen at the lowest dose tested. LOAEC: 13.3 mg/m³ was therefore used as starting point.


Scaling factors were applied to consider for: i) days of exposure (5 rats and 7 consumers), hours of exposure (6 h rats versus 24 h consumers):


LOAECcorrected = 13.3 mg/m3 x 6/24 x 5/7 = 2.37 mg/m3

AF for dose response relationship:
3
Justification:
A NOAEC is not available. Considering the adverse effects observed at 13.3 mg/m3, an assessment factor of 3 is considered as appropriate
AF for differences in duration of exposure:
6
Justification:
From sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
From rats to human
AF for other interspecies differences:
2.5
Justification:
For remaining interspecies differences
AF for intraspecies differences:
10
Justification:
To account for variability between general population
AF for the quality of the whole database:
1
Justification:
Guideline study
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A 28 days dermal study is available but was disregarded due to major methodology deficiencies. A 28 days study via oral route was therefore used to calculate DNEL dermal.
The study was carried out on rats and the NOAEL value found under test conditions was 5 mg/kg bw.
An assessment factor of 2 for route to route extrapolation was applied as dermal adsorption is considered 50 % of the oral one.
The NOAEL used for the derivation of DNEL is 5 mg/kg bw x 2 = 10 mg/kg bw

AF for dose response relationship:
1
Justification:
NOAEL value available
AF for differences in duration of exposure:
6
Justification:
From sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
From rats to human
AF for other interspecies differences:
2.5
Justification:
for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
for variability between general population
AF for the quality of the whole database:
1
Justification:
Guideline study
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.3 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A 28 days study on rats via oral route is available and the NOAEL value found under test conditions was 5 mg/kg bw.

AF for dose response relationship:
1
Justification:
NOAEL value available
AF for differences in duration of exposure:
6
Justification:
From sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
From rats to human
AF for other interspecies differences:
2.5
Justification:
For remaining interspecies differences
AF for intraspecies differences:
10
Justification:
for variability between general population
AF for the quality of the whole database:
1
Justification:
Guideline study
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
240

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population