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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Discussion
No mortalities or clinical signs were observed in the acute oral and dermal studies (LD50 (oral, rat) > 5000 mg/kg bw; LD50 (dermal, rabbit) > 2000 mg/kg bw). No dermal irritation and only slight but fully reversible ocular irritation were observed. Also a classification as skin sensitising was not required. Furthermore, no adverse effects were observed in the repetetive oral studies with rats and rabbits up to the limit dose of 250 mg/kg bw (NOAEL (rat) >= 250 mg/kg bw). Mutagenicity in vitro or in vivo, teratogenicity and effects on fertility in rats and rabbits were also not observed.
Therefore, due to the lack of adverse effects up to the respective limit doses no threshold was identified for any toxicological endpoint. Consequently, no DNELs for workers or the general population have been derived.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Discussion
No mortalities or clinical signs were observed in the acute oral and dermal studies (LD50 (oral, rat) > 5000 mg/kg bw; LD50 (dermal, rabbit) > 2000 mg/kg bw). No dermal irritation and only slight but fully reversible ocular irritation were observed. Also a classification as skin sensitising was not required. Furthermore, no adverse effects were observed in the repetetive oral studies with rats and rabbits up to the limit dose of 250 mg/kg bw (NOAEL (rat) >= 250 mg/kg bw). Mutagenicity in vitro or in vivo, teratogenicity and effects on fertility in rats and rabbits were also not observed.
Therefore, due to the lack of adverse effects up to the respective limit doses no threshold was identified for any toxicological endpoint. Consequently, no DNELs for workers or the general population have been derived.