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Description of key information

The acute toxicity of the test substance was not assessed. Information on oral and dermal acute toxicity are derived from a strucutral analogue.
The test item was applied oral and dermal to rats to evaluate the acute toxicity of the substance (GLP, OECD 423 and 402). LD50 after oral administration > 2000 mg/kg bw. Signs of toxicity were not observed. LD50 after dermal application> 2000 mg/kg bw. Signs of toxicity were not observed. A test on acute inhalative toxicity was not performed.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via dermal route

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

Additional information

The acute toxicity of the test item (intermediate) was not determined. There are reliable studies of an analogue substance (final product) available to assess the potential for acute oral and dermal toxicity. The compounds share high similaritiy in structure, are of low water solubility and have a log Pow > 8. The toxicity profile of the analogue as well as of the test item is determined by the main component; the side products are structural analogues of the main product without influence on substance toxicity. Derived from repeated dose studies with the analogue substance and other analogues of the same compound class and with regard to the molecular weight of the test item (494 g/mol) and the low solubility, it is expected that the test item is of low bioavailability. It is, therefore acceptable to derive information on acute toxicity from experimental data of this read across substance. A detailed risk assessment and read across justification was send to the german chemical agency BAuA in 2007 with the purpose of a national substance notification (VIIA). The read across justification was accepted by the national agency.

A GLP conform study was performed to assess the acute toxicity following oral administration of the analogue in HanBrl: WIST rats according to OECD guideline 423 (RCC Ltd, 2002). To a group of six fasted animals (three males and three females) a single oral dose of the test material preparation (dose volume: 10 ml/kg bw) in PEG 300 at a dose level of 2000 mg/kg body weight was given. The animals were examined for clinical signs daily during the acclimatization period, four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and twice daily on test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. No clinical signs were evident during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.  

Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.

A GLP conform study was performed to assess the acute toxicity following dermal administration of the analogue in HanBrl: WIST rats according to OECD guideline 402 (RCC Ltd, 2002). Five male and five female rats were treated with the test substance (purity: 98.4 weight-%; dose volume: 6.66 g/kg bw) at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 30 % (w/w) and administered at an amount dosage of 6.66 g/kg. The application period was 24 hours.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs were observed during the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. Under the conditions of this study the median lethal dose of the test substance after dermal application was found to be greater than 2000 mg/kg body weight for the male and female animals.

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).