Registration Dossier

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:
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:
no hazard identified
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:
no hazard identified

Additional information - workers

The oral and dermal LD50 of Butanedioic acid, 2,3 -dihydroxy-[R-(R*, R*)]-, C12 -13 -branched alkyl esters and the similar substance were found to be > 2000 mg/kg bodyweight. Therefore the substance is practically nontoxic after short-term exposure. Therefore a DNEL after short-time exposure must not need derived.

Butanedioic acid, 2, 3 -dihydroxy-[R-(R*, R*)]-, C12 -13 -branched alkyl ester are neither an eye irritant nor a skin irritant, therefore also no local DNEL were derived.

There was no evidence of toxicity after dermal administration of 1000 mg/kg bw/d of the structural related substance Butanedioic acid, 2,3 -dihydroxy-di-C14-C15 alkyl esters for 28 days. Based on the study the NOAEL was considered to be at least 1000 mg/kg bw/d. Therefore no hazard is expected and no DNEL has to be derived.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified
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

The oral and dermal LD50 of Butanedioic acid, 2,3 -dihydroxy-[R-(R*, R*)]-, C12 -13 -branched alkyl esters and the similar substance were found to be > 2000 mg/kg bodyweight. Therefore the substance is practically nontoxic after short-term exposure. Therefore a DNEL after short-time exposure must not need derived.

Butanedioic acid, 2,3 -dihydroxy-[R-(R*, R*)]-, C12 -13 -branched alkyl esters and the similar substances are neither an eye irritant nor a skin irritant, therefore also no local DNEL were derived.

There was no evidence of toxicity after dermal administration of 1000 mg/kg bw/d of the structural related substance Butanedioic acid, 2,3 -dihydroxy-di-C14-C15 alkyl esters for 28 days. Based on the study the NOAEL was considered to be at least 1000 mg/kg bw/d. Therefore no hazard is expected and no DNEL has to be derived.

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