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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute oral and dermal toxicity was evaluated in GLP-conform studies according OECD guideline 401 and 402. Neither oral nor dermal administration of the test article at concentrations of 2000 mg/kg bw to rats caused unscheduled deaths. Treatment did not induce signs of toxicity, clinical or pathological abnormalities, also body weight gain and food consumption were unefffected. Thus, LD50 for single oral and dermal administration is considered to be higher than 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Performance and Observation

To evaluate acute oral and dermal toxicity of the test substance, two studies according OECD guideline 401 (CIBA 2001a) and 402 (CIBA 2001b) were performed

In the first study, a group of three male or three female HanBrl: WIST (SPF) rats was treated by oral gavage with the test substance at 2000 mg/kg body weight. The test item was suspended in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. All animals survived until the end of the study period. Slightly ruffled fur was evident in two females at 2000 mg/kg on the first test day. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

In the second study, a group of five male and five female HanBrl: WIST (SPF) rats was treated with the test item at 2000 mg/kg by dermal application. The test item was diluted in vehicle (corn oil) at a concentration of 0.5 g/ml and administered at a volume of 4 ml/kg.

No deaths occurred during the study. Slight erythema on the back were evident in three males and one female on test day 2 additionally in another female on test day 2 and 3. All other animals were without clinical signs. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

 

Discussion

Oral or dermal application of the test substance did not induce mortalities or any signs of toxicity. Also, body weight gain, food consumption and viability were unaffected. Application of the test item onto skin induced slight erythema. All symptoms resolved within the post observation period.

The test item is a viscous liquid and not inhalable. On account of this, a test of acute inhalative toxicity was not performed.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute toxicity under Directive 67/548/EEC, as amended for the 30th time in Directive 2008/58/EC.

                               

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).