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EC number: 945-893-6 | CAS number: -
Guideline acute oral, dermal and inhalation toxicity studies were identified. The L50 / LC50 values determined were as follows:Oral - 7600 mg/kgDermal - > 4300 mg/kgInhalation - 4100 mg/m3
In an acute oral toxicity study, five groups of ten rats (5 males and 5 females) were given a single dose of the appropriate amount of diesel fuel (marketplace sample) (2.5, 5.0, 10, 15, or 20 mL/kg) via oral gavage. Dose levels were chosen to produce expected mortality rates between 10 and 90%. Signs of mortality and toxicity were observed daily for the duration of the study (14 days). Body weight was measured on days 0 and 7, and upon death. Gross necropsy was performed on each animal when they died or by day 14.
Mortality rates of the five dose groups (2.5, 5, 10, 15, 20 mL/kg) were 12.5, 20, 70, 40, and 90% respectively. Signs of toxicity were observed in all dose groups. Severity increased with increased dose. Clinical signs observed were oily urine stains and oily diarrhoea, which resulted in hair loss, irritation, redness, and sores. In many cases, the anal area had open sores. In the highest dose (20 mL/kg) the entire ventral side and legs were affected. In some instances there was blood around the eyes, nose, and mouth. Other symptoms noted included lethargy, pus, or blood at the urinary orifice. Gross pathology observations were also similar in each dose group. In rats who survived for the duration of the study (14 days), there were few abnormalities. In these rats minor observations included enlarged Peyer's patches on intestines. Both animals that died and survived exhibited mild irritation and congestion in the lungs, in addition to fluid-filled abscesses in the lungs. The majority of the animals that died before day 14 showed intestinal damage including, hemorrhaging, thinning of intestinal walls, and increased gas in the gastrointestinal tract.
Under the conditions of this study, the test material had an oral LD50 of 9.0 mL/kg (approx 7600 mg/kg) and a 95% confidence interval of 5.58 and 14.51 mL/kg. the test material was determined to have a median lethal dose according to the study report. The test material is not classified according to EU criteria.
This study received a Klimisch score of 1and is classified as reliable without restriction because it was conducted similar to guideline study OECD 401.
In an acute inhalation toxicity study, groups of young adult Sprague-Dawley rats (10 per sex) were exposed by inhalation route to naval distillate for 4 hours at 2.3, 3.5, or 4.9 mg/L of aerosol. Animals then were observed for 14 days.
Animals had laboured breathing and nasal discharge, but survivors were normal by study termination. Following exposure, animals in all groups lost weight, but body weight at study termination indicated recovery. The inhalation LC50 was determined to be 5.4 mg/L in males, 3.6 mg/L in females, and 4.1 mg/L in combined sexes. The test material is classified as harmful by inhalation according to EU criteria.
This study received a Klimisch score of one and is classified as reliable without restrictions because the study was GLP compliant and was generally conducted according to OECD 403 guidelines.
In an acute dermal toxicity study, 4 male and 4 female New Zealand white rabbits were shaved 24 hours prior to application of test material. This area constituted 30% of the total body surface area. Afterwards, the animals were returned to their stock cages for 24 hours to allow the skin to heal. On testing day, the exposure sites of four animals (2 males and 2 females) were abraded. Minor abrasions were made through the stratum corneum, but not the dermis. A single dose of 5 mL of undiluted test material per kilogram body weight was applied to gauze sponges backed with plastic wrap to help prevent evaporation of the test material. The sponges and plastic wrap were then taped to the shaved area of the rabbit's backs with adhesive tapes. The entire trunk was wrapped with elastic tape and the rabbits were then returned to their cages. After 24 hours, the bandaging was removed and the skin wiped with gauze sponges to remove excess test material. Animals were observed for mortality, local reactions, and behavioural abnormalities daily for 14 days. Body weights were recorded on days 0, 7, and 14. on day 14 all surviving rabbits were subjected to gross necropsy.
During the 14 day study, erythema followed by a drying and flaking of the skin was observed at the test site in all test rabbits. No signs of systemic toxicity were noted. None of the rabbits lost weight during the testing period. The gross post-mortem examinations at 14 days revealed four rabbits with congested kidneys, two with haemorrhages in the trachea, and one with a congested liver. None of these observations were found to be treatment-related. The test material is classified as practically nontoxic.
This study has a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD 434.
Acute toxicity data are available for oral, dermal and inhalation routes. The L50 / LC50 values were as follows:
Oral - 7600 mg/kg
Dermal - > 4300 mg/kg
Inhalation - 4100 mg/m3
The data available do not meet the classification criteria for acute oral and dermal toxicity.
Data on acute inhalation indicate that that material warrants classification as Category 4 inhalation.
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