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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
10.75 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):
200
Dose descriptor starting point:
NOAEL
Value:
1 220 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
2 151 mg/m³
Explanation for the modification of the dose descriptor starting point:

Relevant dose-descriptor; Value: NOAEL: 1220 mg/kg; Remark: This is the concentration where no significant adverse effects were seen in a sub-chronic oral toxicity study.

 

Modification of starting point for rat respiratory volume (Allometric scaling); Value: 0.38 m3/kg bw (rat 8-hour respiratory volume); Remark: A modification of starting point for rat respiratory volume was applied per REACH guidance R.8.4.2. 

 

Modification of starting point for differences in respiratory volumes; Value: 0.67 (6.7 m3/10 m3); Remark: A modification was applied to account for the increased respiratory volumes in active workers as compared to individuals at rest per REACH guidance R.8.4.2. 

Correction Factor: NOAEL of 1220 mg/kg/d / 0.38 m3/kg = 3211 * [6.7 m3/ 10 m3] = 2151 mg/m3  

AF for dose response relationship:
1
Justification:
A factor of 1 is appropriate since the dose descriptor is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
This is a default assessment factor for a sub-chronic study per REACH Guidance R.8.4.3.1.
AF for interspecies differences (allometric scaling):
1
Justification:
A factor of 1 is appropriate since the adjusted start point was via mg/m3 (inhalation) and thus this assessment factor is not applicable per REACH guidance R.8.4.3.1.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
AF for intraspecies differences:
5
Justification:
This is a default assessment factor for workers per REACH Guidance R.8.4.3.1.
AF for the quality of the whole database:
4
Justification:
No repeat dose inhalation studies available that are reliable or reached MTDC (maximum tolerated dose).
AF for remaining uncertainties:
2
Justification:
Route–to-route extrapolation: A factor of 2 is appropriate per REACH guidance R.8.4.2 (oral to inhalation).
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:
12.2 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:
1 220 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

This is the concentration where no significant adverse effects were seen in a subchronic oral toxicity study.

AF for dose response relationship:
1
Justification:
A factor of 1 is appropriate since the dose descriptor is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
This is a default assessment factor for a sub-chronic study per REACH Guidance R.8.4.3.1.
AF for interspecies differences (allometric scaling):
4
Justification:
A factor of 4 is appropriate since the adjusted start point was via mg/kg per REACH guidance 8.4.3.1.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
AF for intraspecies differences:
5
Justification:
This is a default assessment factor for workers per REACH Guidance R.8.4.3.1.
AF for the quality of the whole database:
1
Justification:
A high quality, robust toxicity database exists for this substance.
AF for remaining uncertainties:
1
Justification:
Route–to-route extrapolation: A factor of 1 is appropriate since the animal exposure was via ingestion.
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:
high 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:
2.65 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):
400
Dose descriptor starting point:
NOAEL
Value:
1 220 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 061 mg/m³
Explanation for the modification of the dose descriptor starting point:

Relevant dose-descriptor; Value: NOAEL: 1220 mg/kg; Remark: This is the concentration where no significant adverse effects were seen in a sub-chronic oral toxicity study. 

Modification of starting point for rat respiratory volume (Allometric scaling); Value: 1.15 m3/kg bw (rat 24-hour respiratory volume); Remark: A modification of starting point for rat respiratory volume was applied per REACH guidance R.8.4.2.

AF for dose response relationship:
1
Justification:
A factor of 1 is appropriate since the dose descriptor is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
This is a default assessment factor for a sub-chronic study per REACH Guidance R.8.4.3.1.
AF for interspecies differences (allometric scaling):
1
Justification:
A factor of 1 is appropriate since the adjusted start point was via mg/m3 (inhalation) and thus this assessment factor is not applicable per REACH guidance R.8.4.3.1.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
AF for intraspecies differences:
10
Justification:
This is a default assessment factor for the general population per REACH Guidance R.8.4.3.1
AF for the quality of the whole database:
4
Justification:
A factor of 4 is appropriate because of the lack of repeat dose inhalation data warrants an uncertainty factor of greater than 1.
AF for remaining uncertainties:
2
Justification:
Route-to-route extrapolation: A factor of 2 is appropriate per REACH guidance R.8.4.2 (oral to inhalation).
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:
6.1 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):
200
Dose descriptor starting point:
NOAEL
Value:
1 220 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

This is the concentration where no significant adverse effects were seen in a sub-chronic oral toxicity study.

AF for dose response relationship:
1
Justification:
A factor of 1 is appropriate since the dose descriptor is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
This is a default assessment factor for a sub-chronic study per REACH Guidance R.8.4.3.1.
AF for interspecies differences (allometric scaling):
4
Justification:
A factor of 4 is appropriate since the adjusted start point was via mg/kg per REACH guidance 8.4.3.1.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
AF for intraspecies differences:
10
Justification:
This is a default assessment factor for the general population per REACH Guidance R.8.4.3.1.
AF for the quality of the whole database:
1
Justification:
A high quality, robust toxicity database exists for this substance.
AF for remaining uncertainties:
1
Justification:
Route-to-route extrapolation: A factor of 1 is appropriate since the animal exposure was via ingestion.
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:
6.1 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):
200
Dose descriptor starting point:
NOAEL
Value:
1 220 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

This is the concentration where no significant adverse effects were seen in a sub-chronic oral toxicity study.

AF for dose response relationship:
1
Justification:
This is a default assessment factor for a sub-chronic study per REACH Guidance R.8.4.3.1.
AF for differences in duration of exposure:
2
Justification:
This is a default assessment factor for a sub-chronic study per REACH Guidance R.8.4.3.1.
AF for interspecies differences (allometric scaling):
4
Justification:
A factor of 4 is appropriate since the adjusted start point was via mg/kg per REACH guidance 8.4.3.1.
AF for other interspecies differences:
2.5
Justification:
A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
AF for intraspecies differences:
10
Justification:
This is a default assessment factor for the general population per REACH Guidance R.8.4.3.1.
AF for the quality of the whole database:
1
Justification:
A high quality, robust toxicity database exists for this substance.
AF for remaining uncertainties:
1
Justification:
Route–to-route extrapolation: A factor of 1 is appropriate since the animal exposure was via ingestion.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

The DNEL for general population long-term dermal and oral exposure is derived as follows:

Step 1) Relevant dose-descriptor; Value: 1220 mg/kg (NOAEL); Remark: This is the concentration where no significant adverse effects were seen in a sub-chronic oral toxicity study. |

Step 2) Assessment Factors (AF):

Route–to-route extrapolation; Value: 1; Remark: A factor of 1 is appropriate since the animal exposure was via ingestion.

Animal-to-man scaling factor (Allometric scaling); Value: 4; Remark: A factor of 4 is appropriate since the adjusted start point was via mg/kg per REACH guidance 8.4.3.1.

Interspecies; Value: 2.5; Remark: A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.

Intraspecies; Value: 10; Remark: This is a default assessment factor for the general population per REACH Guidance R.8.4.3.1.

Exposure duration; Value: 2; Remark: This is a default assessment factor for a sub-chronic study per REACH Guidance R.8.4.3.1.

Dose response; Value: 1; Remark: A factor of 1 is appropriate since the dose descriptor is a NOAEL.

Quality of database; Value: 1; Remark: A high quality, robust toxicity database exists for this substance.

DNEL general population long term dermal and oral: Value: 1220 mg/kg bw/day; Remark: 1220 / (1 x 4 x 2.5 x 10 x 2 x 1 x 1) = 2.24 mg/kg bw/day

The DNEL for general population long-term inhalation exposure is derived as follows:

Step 1) Relevant dose-descriptor; Value: NOAEL: 1220 mg/kg; Remark: This is the concentration where no significant adverse effects were seen in a sub-chronic oral toxicity study.

Step 2) Modification of starting point for rat respiratory volume (Allometric scaling); Value: 1.15 m3/kg bw (rat 24-hour respiratory volume); Remark: A modification of starting point for rat respiratory volume was applied per REACH guidance R.8.4.2.

Step 3) Assessment Factors (AF)

Route–to-route extrapolation; Value: 2; Remark: A factor of 2 is appropriate per REACH guidance R.8.4.2 (oral to inhalation).

Animal-to-man scaling factor (Allometric scaling); Value: 1; Remark: A factor of 1 is appropriate since the adjusted start point was via mg/m3(inhalation) and thus this assessment factor is not applicable per REACH guidance R.8.4.3.1.

Interspecies; Value: 2.5; Remark: A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.

Intraspecies; Value: 10; Remark: This is a default assessment factor for the general population per REACH Guidance R.8.4.3.1

Exposure duration; Value: 2; Remark: This is a default assessment factor for a sub-chronic study per REACH Guidance R.8.4.3.1.
Dose response; Value: 1; Remark: A factor of 1 is appropriate since the dose descriptor is a NOAEL.

Quality of database; Value: 4; Remark: A factor of 4 is appropriate because of the lack of repeat dose inhalation data warrants an uncertainty factor of greater than 1.

DNEL general population long term inhalation: Value: 2.65 mg/m3; Remark: 1220 / 1.15 / (2 x 1 x 2.5 x 10 x 2 x 1 x 4) = 2.65 mg/m3