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EC number: 700-684-7
CAS number: 80793-17-5
The acute oral LD50 of AC-6000 is >2500 mg/kg bw. The acute inhalation LC50 of AC-6000 is >139.7 mg/L (analytical concentration) / >153.7 mg/l (nominal concentration). The acute dermal LD50 of AC-6000 is >2000 mg/kg bw.
The study was performed to assess the
acute oral toxicity of the test material following a single oral
administration in the Sprague-Dawley CD strain rat in accordance with
OECD Guideline 423 (Acute Oral toxicity – Acute Toxic Class Method). Six
fasted females (3 females/group) were administered the undiluted test
material orally at a dose level of 2000 mg/kg bodyweight. All animals
showed expected bodyweight gains, and no signs of systemic toxicity,
deaths, or abnormalities at necropsy were observed. The acute median
lethal dose (LD50) of the test material in the female Sprague-Dawley CD
strain rat was estimated to be > 2500 mg/kg bodyweight.
The 4-hour acute inhalation toxicity study was conducted according to OECD 403: Acute Inhalation Toxicity guidelines. Male and female Wistar rats were exposed to vaporised AC-6000 for 4 hrs at nominal/analytical concentrations of 22.85 mg/L (1576 ppm) / 20.90 mg/L (1443 ppm) and 153.7 mg/L (10594 ppm) / 139.7 mg/L (9631 ppm). No deaths or severe toxicity was observed. Non-specific findings associated with restraint (wet fur) were detected at both target concentrations, and breathing irregularities were noted during exposure to the target 10000 ppm concentration. All animals had gained weight by day 15 of the study. No macroscopic findings related to the lung were observed at necropsy, and findings in the testes and epididymis of the same animal were not considered to be treatment related. Therefore, the median lethal concentration of AC-6000 is > 153.7 mg/L (nominal) / 139.7 mg/L (analytical).
The acute dermal toxicity study was conducted in accordance with OECD 402 (Acute Dermal Toxicity), EU Method B.3 (Acute Toxicity (Dermal)), and EPA OPPTS 870.1200 (Acute Dermal Toxicity) guidelines. AC-6000 was applied dermally to male and female Wistar rats. The test substance was held in place for 24 hrs to an area approximately 10% of the total body surface, after which dressings were removed and residual test substance washed off with tap water. One male was found dead on Day 2. No further mortality occurred. On Days 1 and/or 2 males showed hunched posture, ptosis, chromodacyorrhea and/or flat posture, and two females showed chromodacryorrhea. One male had scabs on the treated skin-area. Changes in body weight were within the range expected for rats used in this type of study, and were not considered indicative of toxicity. There were no macroscopic abnormalities found at necropsy. Therefore, the dermal LD50 of AC-6000 in Wistar rats is >2000 mg/kg body weight.
Acute oral toxicity
In a GLP compliant study according to OECD guideline 423 and EU method B.1 the acute oral toxicity of AC-6000 following a single oral administration in the Sprague-Dawley CD strain rat was investigated (SafePharm Laboratories, 2006).
A group of three fasted females was treated with AC-6000 at a dose level of 2000 mg/kg bw by gavage. This was followed by a further group of three fasted females at the same dose level. The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths or signs of systemic toxicity. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bw.
Acute inhalation toxicity
In a GLP compliant study according to OECD guideline 403 and EU method B.2 the acute inhalation toxicity of AC-6000 following a single four-hour inhalation period in the Wistar strain rat was investigated (Syngenta Central Toxicology Laboratory, 2007). Two groups, each containing five male and five female animals, were exposed nose-only to AC-6000 at a target concentration of either 1400 ppm (analytical concentration of 1443 ppm / 20.9 mg/L) or 10000 ppm (analytical concentration of 9631 ppm / 139.7 mg/L). Following exposure, the animals were retained without treatment for 14 days. Clinical observations and bodyweights were recorded throughout the study and at the end of the scheduled period, the animals were killed and subjected to a gross examination.
No animals died during the study. Clinical findings were mainly confined to observations associated with restraint (wet fur) with only transient irregular breathing noted in animals during exposure to the highest concentration. All animals gained weight during the study. At necropsy, no treatment related macroscopic findings were noted.
Nose-only exposure for 4 hours to target concentrations of 1400 ppm (analytical concentration of 1443 ppm / 20.9 mg/L) or 10000 ppm (analytical concentration of 9631 ppm / 139.7 mg/L) resulted in no deaths and no adverse effects. It is concluded that the median lethal concentration of AC-6000 exceeds 10000 ppm (analytical concentration of 9631 ppm / 139.7 mg/L).
Acute dermal toxicity
In a GLP compliant study according to OECD guideline 402 and EU method B.3, the acute dermal toxicity of AC-6000 following a single dermal application for 24 hours in the Wistar strain rat was investigated (NOTOX B.V., 2008). A group of five male and five female animals were exposed to AC-6000 at a dose level of 2000 mg/kg bw. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (day 15).
On male was found dead on day 2. No further mortality occurred. The males showed hunched posture, ptosis, chromodacryorrhea and/or flat posture on days 1 and 2. Two females showed chromodacryorrhea on days 1 and/or 2. Scabs were seen in the treated skin-area of one male during the study period. The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals.
The dermal LD50 value of AC-6000 in Wistar rats was established to exceed 2000 mg/kg bw.
Based on the results of the acute oral, inhalation and dermal toxicity studies, classification according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is not needed.
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