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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

In an acute oral study performed per EPA TSCA 40 CFR 798.1175 the LD50 in the rat was 1.77 g/kg. An additional study determined that the combined male and female LD50 was 2.82 g/kg.

In an acute dermal study performed per OECD Test Guideline 402 and OPPTS 870.1200 the LD50 in the rabbit was >2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 770 mg/kg bw
Quality of whole database:
A single guideline compliant study conducted under GLP conditions is available. The quality of the database is therefore considered to be good.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
A single guideline compliant study conducted under GLP conditions is available. The quality of the database is therefore considered to be good.

Additional information

The acute oral toxicity was investigated in a fixed dose procedure performed per EPA TSCA 40 CFR 798.1175 under GLP conditions (Hill Top Biolabs, Inc., 1990).

The test material was administered as a 25 % w/v formulation in corn oil to groups of male and female young adult Sprague Dawley rats at dose levels of 5.0, 2.5, 1.25, and 0.625 g/kg (two rats per sex per dose).

Under the conditions of this study, the acute oral LD50 was 1770 mg/kg.

 

The acute dermal toxicity was investigated in a procedure performed per OECD Test Guideline 402 and OPPTS 870.1200 under GLP conditions (Toxikon Corporation, 2003).

Five male and five female New Zealand White rabbits were exposed to the test material in an occlusive fashion for 24 hours at a limit dose of 2000 mg/kg.

Under the conditions of this study, the acute dermal LD50 was >2000 mg/kg bw.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance requires classification with respect to acute toxicity via the oral route as Acute Tox Category 4 (H302: Harmful if swallowed).