Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: 
There is no specific toxicokinetic studies available on the substance. The substance is easily hydrolysed into maleamic acid (CAS No. 555-59-9) and also ultimately hydrolyzed into maleic acid (CAS No. 108-31-6) and aniline (CAS No 62-53-3). The water solubility of the hydrolysis products and the considerations on the metabolism, accumulation of these products are considered to be unlikely.
In the 30 day repeat dose toxicity study, NOAEL was estimated as 3.5 mg/kg·day and the toxicological significance were observed symptom by tranient irritation. In relation to carcinogenicity, no data is available, but genetic toxicity is considered to be negative. This means this substance is not considered as bioaccumulation potential.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

No specific toxicokinetic studies are available.

The data available show that the primary action of the substance is due either directly or indirectly to its corrosive nature which demonstrates clear absorption via oral, dermal and inhalation routes of exposure.

There are no reliable findings which are not considered as related to the corrosive nature of the substance, even through the substance was administered at non corrosive concentrations. Hence no conclusions can be inferred about the substances distribution, metabolism or excretion.

In relation to bioaccumulation the substance has a low LogPow (1.16) which indicates a low potential for bioaccumulation.

Discussion on bioaccumulation potential result:

No specific toxicokinetic studies are available.

The data available show that the primary action of the substance is due either directly or indirectly to its corrosive nature which demonstrates clear absorption via oral, dermal and inhalation routes of exposure.

There are no reliable findings which are not considered as related to the corrosive nature of the substance, even through the substance was administered at non corrosive concentrations. Hence no conclusions can be inferred about the substances distribution, metabolism or excretion.

In relation to bioaccumulation the substance has a low LogPow (1.16) which indicates a low potential for bioaccumulation.