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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
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

Workers - Hazard via dermal route

Systemic effects

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

During the subacute repeated dose toxicity/reproductive toxicity tests available, no NOAEL could not be determined due to absence of adverse toxic effects at the highest tested concentration of 1000 mg/kg bw/day; therefore no Derived No Effect Levels for both inhalation and dermal long-term exposure, systemic effects, are estimated.

No DNEL is derived for inhalation acute exposure, systemic effects, based on the physical state of the substance, inhalation is not an appropriate route of exposure. In addition, no DNEL is derived for both long-term/acute local effects because significant exposure by inhalation route is unlikely to occur due to the physical state of the substance; the substance is not irritant for skin/eyes and an effect on mucous is not expected.

No DNEL is derived for dermal acute exposure, systemic effects, because no acute toxicity potential was observed up to 2000 mg/kg bw. Since no substance-related local effects were observed, no DNEL for long-term dermal local effects was derived. In addition, the substance is not skin irritating, therefore no hazard has been identified for local effects due to acute dermal exposure.

Also regarding the eye irritation potential, no hazard has been identified on the basis of the available investigations.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
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:
no hazard identified
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:
hazard unknown but no further hazard information necessary as no exposure expected
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:
no hazard identified
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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

During the subacute repeated dose toxicity/reproductive toxicity tests available, no NOAEL could not be determined due to absence of adverse toxic effects at the highest tested concentration of 1000 mg/kg bw/day; therefore no Derived No Effect Levels for inhalation, dermal and oral long-term exposure, systemic effects, are estimated.

No DNEL is derived for inhalation acute exposure, systemic effects, based on the physical state of the substance, inhalation is not an appropriate route of exposure. In addition, no DNEL is derived for both long-term/acute local effects because significant exposure by inhalation route is unlikely to occur due to the physical state of the substance; the substance is not irritant for skin/eyes and an effect on mucous is not expected.

No DNEL is derived for either oral or dermal acute exposure, systemic effects, because no acute toxicity potential was observed up to 5000 and 2000 mg/kg bw, respectively.

Since no substance-related local effects were observed, no DNEL for long-term dermal local effects was derived. In addition, the substance is not skin irritating, therefore no hazard has been identified for local effects due to acute dermal exposure.

Also regarding the eye irritation potential, no hazard has been identified on the basis of the available investigations.