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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

No adverse effects have been observed in a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD 422, GLP) at the highest dose tested, equivalent to 791 mg/kg bw/day (males) and to 887 -1768 mg/kg bw/day (females) (achieved dose).

Moreover, tests assessing the mutagenic potential of the substance in vitro provided no evidence of mutagenic or genotoxic activity.

Indications of toxicity to reproduction and development were not observed in the Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test.

No systemic adverse effect was identified in the acute toxicity study by oral route performed on the substance, excepted narcotic effects observed at 2000 mg/kg bw (STOT SE3 H336).

The substance is classified as skin corrosive Category 1B/1C and eye damage Category 1, thus it is categorized in the “moderate hazard” band according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part E, Table E.3-1. Therefore, a qualitative risk characterisation was followed for skin, eye and respiratory irritation. Narcotic effects are categorized in the "low hazard" band, and are therefore covered when the "moderate hazard" band RMM/OCs are applied.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

No acute toxicity hazard (leading to C&L) has been identified for the substance following oral exposure. By extrapolation, no systemic effect after acute inhalation exposure is expected to occur. Therefore, according to ECHA R8 Guidance, no DNEL (acute) should be set.

However, the substance being classified as STOT-SE 3 for narcotic effects, a qualitative risk characterisation was followed. Although this hazard is not listed in the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part E, Table E.3-1, the substance is categorized in the “low hazard” band. Adverse effects are controlled by substance concentration (in that case < 1 %, i.e. the SCL for a corrosive substance) in product for consumer.

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
medium hazard (no threshold derived)

Additional information - General Population

No adverse effects have been observed in a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD 422, GLP) at the highest dose tested, equivalent to 791 mg/kg bw/day (males) and to 887 -1768 mg/kg bw/day (females) (achieved dose).

Moreover, tests assessing the mutagenic potential of the substance in vitro provided no evidence of mutagenic or genotoxic activity.

Indications of toxicity to reproduction and development were not observed in the Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test.

A qualitative risk characterisation was followed for skin and eye corrosion. The substance is categorized in the “medium hazard” band according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part E, Table E.3-1. Adverse effects are controlled by substance concentration (in that case < 1 %, i.e. the SCL for a corrosive substance) in product for consumer. This SCL also protect from narcotic effects