Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.21 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:
6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation required for Oral to Inhalation routes as no long term inhalation study available

Converted the oral 90 day study for route to route extrapolation

NOAEL 6mg/kg/day X (1/0.38) x 0.5 x 0.67 = NOAEC = 5.2 mg/m3

Then used AF as per guidance on ECHA.

AF for dose response relationship:
1
Justification:
WHen starting point for DNEL calcuation is NOAEL the default AF = 1
AF for differences in duration of exposure:
2
Justification:
default AF used for conversion of sub chronic ( 90 day ) to chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
AF for allometric sclaing not required as differences were considered and taken into account during the conversion from Oral to inhalation starting point.
AF for other interspecies differences:
2.5
Justification:
default for other species differences
AF for intraspecies differences:
5
Justification:
default for worker popultation
AF for the quality of the whole database:
1
Justification:
Study was relaible and conducted to GLP
AF for remaining uncertainties:
1
Justification:
n/a
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
ECHA REACH Guidance

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 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):
10
Dose descriptor starting point:
NOAEL
Value:
6 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

ECHA R.7c guidance and it suggests that for substances with molecular weight greater than 500 and Log Kow < -1 or > 4, a dermal absorption value of 10% can be used, rather than the default of 100%.  This would be applicable for Arb Z as the molecular weight = 730 and log Kow > 6.5. 

So instead of 100 as AF , the AF is 10, to account for 10% dermal absorption rather than 100%

AF for dose response relationship:
1
Justification:
Strarting point is NOAEL- Echa practical guide 14 states AF can be equal or greater than 1
AF for differences in duration of exposure:
2
Justification:
based on 90 day Oral study
AF for interspecies differences (allometric scaling):
4
Justification:
Dermal
Long-term
systemic
AF for difference in duration of exposure: 2 (based on a 90 day study)
AF for other interspecies differences:
2.5
Justification:
Practical guide 14
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
reliable data K1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Explanation for the modification of the dose descriptor starting point:

An acute in vivo dermal toxicity study showed no irritancy but its not possible to derive a acute dnel for dermal exposure & systemic effects from this study. No hazard identified is the conclusion.

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
ECHA REACH Guidance

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.104 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):
50
Dose descriptor starting point:
NOAEC
Value:
5.2 mg/m³
Explanation for the modification of the dose descriptor starting point:

Converted the oral 90 day study for route to route extrapolation

NOAEL 6mg/kg/day X (1/0.38) x 0.5 x 0.67 = NOAEC = 5.2 mg/m3

Then used AF as per practical guide 14 ECHA.

AF for duration of exposure - sub chrnic to chronic = 2

AF interspecies diff 2.5

AD intra spec diff = 10

Total AF = 50

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
ECHA REACH Guidance

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
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:
0.03 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:
6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

As per echa guidance - practical guide 14

Dermal long term systemic General population

Af for duration of exposure = 2

AF for interspecies = 4

AF for other intersp diff= 2.5

Af for intraspec difference in consumers , general population = 10

Total = 200

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:
0.03 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
Explanation for the modification of the dose descriptor starting point:

As per Echa guidance - Practical guide 14

Oral long term systemic - Overall assesment factor,

2 based on Oral 90 day study (NOAEL = 6mg/kg/day )

4 for Intersp rat

2.5 for intersp differences

10 intraspec diff in general poplation

total AF = 200

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population