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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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.