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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
16.8 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:
340 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
420 mg/m³
Explanation for the modification of the dose descriptor starting point:

An inhalative long-term study according to OECD TG 422 is available. However, this study is deemed inadequate for the derivation of the long term inhalative DNEL for workers, since no systemic effects were observed in this study and putting the NOEAC on a level with the high dose might be a poor estimate. Therefore, the worker-DNEL long-term for inhalation route - systemic is derived from the oral NOAEL of 340 mg/kg bw/day, obtained in the Extended One-Generation Reproductive Toxicity Study (OECD TG 443) in Wistar rats. The NOAECcorr. is calculated as follows:


- standard respiratory volume rat = 0.38 m³/kg/8h


- standard respiratory volume human = 6.7 m³/8h


- worker respiratory volume = 10 m³/8h


- absorption (oral, rat) = 50 % (default)


- absorption (inhalative, human) = 100 % (default)


- experimental exposure time = 7 days/week


- exposure time worker = 5 days/week


--> modified dose descriptor (corrected inhalatory NOAEC) = 340 mg/kg bw/day * (1/0.38 m³/kg/d) * (6.7 m³ (8h)/10 m³ (8h)) * (50%/100%) * (7 exposure days/week; rat/5 exposure days/week; worker) = 420 mg/m³

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance: starting point for the DNEL calculation is a NOAEL
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance: Extrapolation from sub-chronic to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance: no additional factor needed for extrapolation from oral to inhalation route
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance: default
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance: default factor for worker
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance: good quality of data base
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance: default factor
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:
0.15 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor:
NOAEC
Value:
4 mg/m³
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance: starting point for the DNEL calculation is a NOAC
AF for differences in duration of exposure:
6
Justification:
ECHA REACH Guidance: Extrapolation from sub-acute to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance: no additional factor needed
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance: default
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance: default factor for worker
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance: good quality of data base
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance: default factor
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:
4.8 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:
340
Modified dose descriptor starting point:
NOAEL
Value:
467
Explanation for the modification of the dose descriptor starting point:

A dermal long-term study according to OECD TG 411 is available. However, this study is deemed inadequate for the derivation of the long term dermal systemic DNEL for workers, since no systemic effects were observed in this study and putting the NOEAL on a level with the high dose might be a poor estimate. Therefore, the worker-DNEL long-term for dermal route - systemic is derived from the oral NOAEL of 340 mg/kg bw/day, obtained in the Extended One-Generation Reproductive Toxicity Study (OECD TG 443) in Wistar rats. The NOAELcorr. is calculated as follows:


- experimental exposure time = 7 days/week


- exposure time worker = 5 days/week


--> modified dose descriptor (corrected dermal NOAEL) = 340 mg/kg bw/day * (7 exposure days/week; rat/5 exposure days/week; worker) = 476 mg/kg bw/day

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance: starting point for the DNEL calculation is a NOAEL
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance: Extrapolation from sub-chronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance: default factor for extrapolation from rat to human
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance: default
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance: default factor for worker
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance: good quality of data base
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance: default factor
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

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:
hazard unknown but no further hazard information necessary as no exposure expected
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 but no further hazard information necessary as no exposure expected
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:
hazard unknown but no further hazard information necessary as no exposure expected
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 but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 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:
340 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification is necessary.

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance: starting point for the DNEL calculation is a NOAEL
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance: Extrapolation from sub-chronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance: default factor for extrapolation from rat to human
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance: default
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance: default factor for the general population
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance: good quality of data base
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance: default factor
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 for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population