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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DMEL (Derived Minimum Effect Level)
Value:
3.5 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):
75
Modified dose descriptor starting point:
NOAEC
Value:
264 mg/m³
Explanation for the modification of the dose descriptor starting point:
for route extrapolation conditional decline (bw loss, decreased body weight gain and food consumption) is taken as systemic toxicity.
AF for dose response relationship:
1
Justification:
starting point is mid-dose NOAEL in a subacute (gavage) study
AF for differences in duration of exposure:
6
Justification:
The extrapolation factor from short term toxicity to the long-term scenario for a substance causing primary local toxicity is reduced by factor 2. For local irritation the concentration is in most cases the relevant parameter, and prolongation of exposure is expected to influence the severity of effect and morphology of changes, but not the NOAEL/NOAEC.
AF for interspecies differences (allometric scaling):
1
Justification:
allometric scaling is not applicable for inhalation
AF for other interspecies differences:
2.5
Justification:
default (not justified for local tox.)
AF for intraspecies differences:
5
Justification:
worker population
AF for the quality of the whole database:
1
Justification:
GLP compliant study data
AF for remaining uncertainties:
1
Justification:
Equal absorption for oral ingestion and inhalation has been assessed from physico-chemical properties of the substance.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
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):
12.5
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC
Value:
264 mg/m³
Explanation for the modification of the dose descriptor starting point:
for route extrapolation conditional decline (bw loss, decreased body weight gain and food consumption) is taken as systemic toxicity.
AF for dose response relationship:
1
Justification:
starting point is mid-dose NOAEL in a subacute (gavage) study
AF for interspecies differences (allometric scaling):
1
Justification:
allometric scaling is not applicable for inhalation
AF for other interspecies differences:
2.5
Justification:
default (not justified for local tox.)
AF for intraspecies differences:
5
Justification:
worker population
AF for the quality of the whole database:
1
Justification:
GLP compliant study data
AF for remaining uncertainties:
1
Justification:
Equal absorption for oral ingestion and inhalation has been assessed from physico-chemical properties of the substance.

Local effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
3 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
6 mg/m³
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

From its toxicological profile this substance is not hazardous and thus it does not meet with the criteria for classification. From an occupational health and safety perspective this solid substance poses a relevant concern: During milling and masterbatching an (physically) hazardous chemical agent (respirable dust, alveolar fraction) is produced and consumed into polymeric matrix under (industrial) strictly controlled conditions. The existing, legal binding OEL (respirable dust < 5µm) is considered to give sufficient protection for the worker.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
AF for dose response relationship:
1
Justification:
because starting point is NOAEL (LOAEL=1000 mg/kg bw/day)
AF for differences in duration of exposure:
6
Justification:
based on a 28 day gavage study
AF for interspecies differences (allometric scaling):
4
Justification:
default extrapolation factor for rat data, but toxicokinetic is not relevant
AF for other interspecies differences:
2.5
Justification:
no justification of toxicodynamic differences (default)
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
GLP compliant data
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

From its toxicological profile this substance is not hazardous and thus it does not meet with criteria for classification.

With the substance embedded in polymer articles neither a short term nor a long term exposure of the general population is expected.