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EC number: 614-406-6 | CAS number: 68308-61-2
Endpoint summary
Administrative data
Description of key information
The test substance GARDO TP 10451 was examined in an acute oral and dermal toxicity study in rats.
Oral LD50 female animals: > 2000 mg/kg bw
Dermal LD50 male animals: > 2000 mg/kg bw
Dermal LD50 female animals: >= 2000 mg/kg bw
Key value for chemical safety assessment
Additional information
Acute toxicity oral
In an acute oral toxicity study (08/625 -001P) 4 groups of three female CRL:(WI) BR Wistar rats at an approximate age of 8 -9 weeks, weighing of 183 -197 g were administrated by single oral gavage at dose levels of 300 and 2000 mg/kg body weight of the test substance GARDO TP 10451. The animals were observed daily for 14 days after dosing. GADRO TP 10451 did not cause mortality at 300 and 2000 mg/kg bw dose levels. No clinical signs were observed. After the animals were scarified at the end of the observation period no test item related macroscopic changes were found.
The LD50 value was greater than 2000 mg/kg body weight in female CRL:(WI)BR rats.
The study was conducted according to the OECD guideline 423 and the EU-Guideline B.1.
Acute toxicity dermal
In an acute dermal toxicity study (08/625 -002P) 5 male and 5 female young adult CLR:(WI) BR Wistar rats with a body weight range of 246 - 283 g (male and 201 - 216 g (female) were treated with GARDO TP 10451 for a single 24 -hour dermal exposure in its original form at a dose level of 2000 mg/kg bw. The animals were observed for 14 days after treatment. No mortality and no clinical signs occured. After the animals were scarified at the end of the observation period no test item related macroscopic changes were found.
The LD50 value is grater than 2000 mg/kg body weight in male and female CRL:(WI)BR rats.
The study was conducted according to the OECD guideline 402 and the EU-Guideline B.3.
Justification for classification or non-classification
The LD50 value dervied from the acute oral toxicity study was greater than 2000 mg/kg body weight in female rats, grouping the test substance into category 5 the substance is categorized as "Unclassified". The results of the acute dermal toxicity study direct also the test substance into category 5 with a LD50 greater than 2000 mg/kg body weight for male and female rats.
Hence, altogether the test substance GARDO TP 10451 is unclassified for acute toxic effects according to the CLP/GHS.
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