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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
6.518 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:
NOAEC
Value:
29.1 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
162.96 mg/m³
Explanation for the modification of the dose descriptor starting point:

A correction by a factor of 1.4 is justified, as the rats were exposed for 7 days per weeks whereas the worker is only exposed for 5 days /week.

Based on the available acute toxicity data, there is a clear difference between oral and inhalation uptake indicated by differences observed in mortality patterns that lead to classification for acute oral toxicity Cat. 4 vs. no classification by inhalation route. Furthermore, based on the particle size distribution (only 8 % of the particles have a particle size of 20µm or less and are thus able to reach the alveolar region of the respiratory tract) observed in the granulometry study and based on the low vapor pressure of the substance (0.00001 hPa at 20 °C), inhalation exposure and uptake via inhalation will be low, thus a correction factor of at least 5.6 (4 x 1.4) is justified (assuming a worst case 25 % absorption by inhalation instead of 100 % by oral route) leading to a corrected starting point of 162.96 mg/m3 for DNEL derivation.

AF for dose response relationship:
1
Justification:
default ECHA guidance R.8
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
1
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
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:
1.386 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:
16.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
138.6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A correction by a factor of 1.4 is justified, as the rats were exposed for 7 days per weeks whereas the worker is only exposed for 5 days /week.

Based on differences between oral (LD50 < 1000 mg/kg) and dermal LD50 (> 5000 mg/kg) values by a factor of 5-6, there is clear evidence that dermal uptake is considerably lower than oral uptake. The oral systemic long-term NOAEL was therefore modified by a factor of 8.4 (6 x 1.4) (dermal uptake in the range of 10-20 % compared to 100 % oral uptake) for derivation of a dermal systemic long-term DNEL. The corrected starting point for DNEL derivation was thus a corrected NAOEL of 138.6 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
default ECHA guidance R.8
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
1
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
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:
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:
1.14 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
Value:
14.35 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
57.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

Based on the available acute toxicity data, there is a clear difference between oral and inhalation uptake indicated by differences observed in mortality patterns that lead to classification for acute oral toxicity Cat. 4 vs. no classification by inhalation route. Furthermore, based on the particle size distribution (only 8 % of the particles have a particle size of 20µm or less and are thus able to reach the alveolar region of the respiratory tract)observed in the granulometry study and based on the low vapor pressure of the substance (0.00001 hPa at 20 °C), inhalation exposure and uptake via inhalation will be low, thus a correction factor of at least 4 is justified (assuming a worst case 25 % absorption by inhalation instead of 100 % by oral route) leading to a corrected starting point of 57.4 mg/m3 for DNEL derivation.

AF for dose response relationship:
1
Justification:
default ECHA guidance R.8
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
1
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
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:
DNEL (Derived No Effect Level)
Value:
0.495 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:
16.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
99 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Based on differences between oral (LD50 < 1000 mg/kg) and dermal LD50 (> 5000 mg/kg) values by a factor of 5-6, there is clear evidence that dermal uptake is considerably lower than oral uptake. The oral systemic long-term NOAEL was therefore modified by a factor of 6 (dermal uptake in the range of 10-20 % compared to 100 % oral uptake) for derivation of a dermal systemic long-term DNEL. The corrected starting point for DNEL derivation was thus a corrected NAOEL of 99 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
default ECHA guidance R.8
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
1
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
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:
0.083 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:
16.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification of the dose descriptor was performed for the oral route.

AF for dose response relationship:
1
Justification:
default ECHA guidance R.8
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
1
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population