Registration Dossier
Registration Dossier
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EC number: 459-520-5 | CAS number: 132182-92-4
Endpoint summary
Administrative data
Description of key information
Acute oral, inhalation, and dermal toxicity studies have been conducted on HFE-7300. The results of the studies are:
Acute oral toxicity is greater than 2000 mg/kg body weight in rats when tested according to OECD 423.
Acute inhalation toxicity is greater than 428 mg/L, vapor, in rats when tested according to a custom protocol.
Acute dermal toxicity is greater than 2000 mg/kg body weight in rats when tested according to OECD 404.
Key value for chemical safety assessment
Additional information
The acute oral toxicity potential of the test article was evaluated in female Wistar rats. The study was conducted in compliance with OECD GLP (1997). The test method was based on OECD 423 (2001). A single dose of the test article was administered by oral gavage to two subsequent groups of three female wistar rats at 2000 mg/kg body weight. Animals were observed for mortality (twice daily), clinical signs (periodically on dosing day, daily thereafter until Day 15), and body weights (Day 1, 8, and 15). Macroscopic examination was performed upon sacrifice (Day 15). No mortality occurred during the study. Hunched posture and piloerection were noted in all animals on Day 1 and hunched posture was noted in one animal on Day 2. Body weights were considered normal for all animals and no macroscopic abnormalities were noted upon necropsy. Based on the results of the study, the oral LD50 for the test article is greater than 2000 mg/kg body weight.
The acute inhalation toxicity potential of the test article was evaluated in male Sprague Dawley rats. The study was not conducted in compliance with GLP regulations. The test method was based on a custom protocol. Rat (N=4) were exposure, whole body, to an atmosphere containing 30000 ppm (v/v) (428 mg/L, vapor), for 4 hours. Control animals (N=4) were exposed in a similar manner without the addition of the test article. Observations for mortality (daily), clinical signs (daily), and body weights (prior to dosing and daily thereafter) were noted. No mortality occurred during the study. No abnormal clinical signs were noted. Body weights were comparable to controls throughout the study. No abnormalities were observed upon gross necropsy. Based on the results of the study, the inhalation LC50 for the test article is greater than 428 mg/L, vapor.
The acute dermal toxicity potential of the test article was evaluated in Wistar rats. The study was conducted in compliance with OECD GLP (1997) regulations. The test method was based on OECD No. 402 (1987); EC Council Directive 67/548/EEC, Annex V, B.3 (1992); OPPTS 870.1200 (1998); JMAFF Guidelines (2000). The test article (liquid - dosed undiluted) was administered to 5 Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight and held in place for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrafice (day 15). No mortality occurred. Chromodacryorrhoea was noted among animals on day 1. Scabs or scales were noted in the treated skin area of 2 females between day 7 and 15. The body weight gain during the observation period was within the range expected. No abnormalities were found at the macroscopic post mortem examination. Based on the results of the study, the dermal LD50 for the test article was greater than 2000 mg/kg body weight.
Justification for classification or non-classification
The results for the test article do not meet the criteria for classification as harmful or toxic by inhalation, ingestion, or dermal exposure.
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