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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 a repeated dose study the test substance was applied up to 50 mg/kg bw to Albino rabbits via the dermal route. No mortality occured and no systemic effects were observed.

Key value for chemical safety assessment

Additional information

Oral route:

No studies available.

Dermal route:

One study is available, where repeated dose toxicity of Orasol Brown 2GL was tested via the dermal administration route. In the first study (IBL, 1966) Albino rabbits were divided into 3 groups, namely 2 test groups (10, 50 mg/kg bw) and 1 control group (1 ml/kg bw dimethyl phthalate). Per dose 1 male and 1 female rabbit was treated each on intact and abraded skin (in summary 2 males and 2 females per dose). In the control group the number of animals was doubled. The test substance was applied in dimethyl phthalate. Applications were administered five consecutive days per week for three weeks. The material was permitted to remain in contact with the animals' skins for six hours per day, the backs being wiped at the end of each daily exposure. Fifteen exposures were made. Control animals were handled in a manner similar to the test animals.

General appearance and behaviour was reported without details. At least after termination of study the animals were observed for skin irritational effects of the test substance. Investigations of body weight and hematology were performed. Additionally pahology and histopathology was performed in the following organs and tissues: Brain, Thyroid, Adrenal, Lung, Heart, Spleen, Bone Marrow, Stomach, Intestines, Pancreas, Liver, Kidney, Testes, Skeletal Muscle, Skin.

No mortality occured and no systemic effects have been observed. In all respects the treated groups behaved in a manner similar to the controls based upon gross observation. A NOAEL of at least 50 mg/kg bw was deduced.

Inhalation route:

No studies available.

Justification for classification or non-classification

The available study on subacute dermal toxicity does not include sufficient information in order to conclude on the absence of hazard. It gives however no rise of concern. The substance is not classified for repeated toxicity due to missing data.