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EC number: 939-273-4 | CAS number: -
LD50 oral rat > 2000 mg/Kg bwLD50 dermal rat > 2000 mg/Kg bw
The acute toxicity of PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO, SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1 was investigated following a single oral administration (10 mL/kg in corn oil) to the Sprague Dawley rat followed by a 14-day observation period.
A sighting study was performed in which a single female animal was dosed at 2000 mg/kg. No mortality and no clinical signs were seen during the observation period.
A main study was then performed on an additional 4 females which were dosed at 2000 mg/kg. No mortality occurred. No clinical signs considered related to the toxicity of the test item were noted during the observation period.
The body weight changes observed in the animals were not remarkable with the exception of body weight loss observed in a single animal showing signs that could be unrelated to the toxicity of the test item. All animals were killed at the end of the observation period and subjected to necropsy examination. No abnormalities were observed at the necropsy examination performed on termination of the observation period in 4 out of 5 animals treated. In the remaining animal, swollen abdomen, gas content and swelling were observed in the gastrointestinal tract.
These results indicate that the test item, PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO, SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1, has no toxic effect on the rat following oral administration of single doses of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight.
The acute toxicity of PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO,SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1 was investigated following dermal administration of a single dose to the rat. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days all animals were killed and subjected to necropsy examination.
No mortality occurred in male or female animals after treatment during the observation period. Clinical signs observed were limited to the treatment site in which redness and/or scabs and/or desquamation and/or fissuring were generally observed during the study. However, all males recovered from these signs by Day 13 while all females by Day 15. The reaction in the treated site demonstrates that the test item was not well tolerated by the skin of the rats after 24 hours of semi-occlusive exposure. The body weight changes observed during the study were within the expected range for this species and age of animals.
No abnormalities were found at necropsy carried out in the animals at termination of the study.
These results indicate that the test item, PARAFFIN WAXES AND HYDROCARBON WAXES, CHLORO,SULFOCHLORINATED SAPONIFIED (C14-C17) SSP-SAMPLE 1, has no systemic toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:
Classification: No Category
Signal word : No Signal word required
Hazard statement: No hazard statement required
Just two good studies are available on the substance, but both agreed in not showing any clinical sign and any toxicity at doses of 2000 mg/Kg bw for oral and dermal routes
Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1 of CLP Regulation. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). The limit value that can trigger to Classification is 2000 mg/Kg both for oral and dermal exposure pattern
No classification for acute toxicity oral is warranted under Regulation 1272/2008
No classification for acute toxicity dermal is warranted under Regulation 1272/2008
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