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EC number: 938-445-6 | CAS number: -
Key studies for oral and dermal acute toxicity were performed, demonstrating LD50 >2000 mg/kg bw after both routes. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for the test item due to the substance properties and the risk management measures that are already implemented.
The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:
- OECD Guideline for Testing of Chemicals No 423
- EU Method B.1 tris Acute toxicity (oral) of Commission Regulation (EC) No. 440/2008 (Acute Toxic Class Method)
Following a test at a dose level of 2000 mg/kg, an additional three female animals were given a single oral dose of test material, as a suspension in water, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Morality: There were no deaths.
Moderately reduced spontaneous activity, slight to moderate piloerection, catalepsia and half eyelid-closure was noted in all animals on day one after dosing. 3 of 6 animals appeared normal on day two after dosing. 3 of 6 animals showed slight piloerection on day two after dosing. All animals appeared normal three days after dosing.
Based on these results and according to the acute toxic class method regime no further testing was required.
None of the animals showed weight loss during the observation period.
No specific gross pathological changes were recorded for any animal.
Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but not mortality. The median lethal dose after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 5000 mg/ kg bw. In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item has no obligatory labelling requirement for toxicity. According to Annex I of Regulation (EC) 1272/2008 the test item has no obligatory labelling requirement for toxicity and is not classified. According to GHS (Globally Harmonized Classification System) the test item has obligatory labelling requirement for toxicity and is classified into Category 5.
A study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to meet the requirements of the following:
- OECD Guidelines for Testing of Chemicals No 402 “Acute Dermal Toxicity” (adopted 24 February 1987)
- Method B.3 Acute Toxicity (Dermal) of Commission Regulation (EC) No. 440/2008
A group of ten animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of the test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths.
There were no signs of systemic toxicity.
The test item showed signs of irritation. Erythema grade 1 but no oedema was observed in all animals. Desquamation and scratches were also observed in all animals. Eschar was observed in 1 of 5 female animals.
All signs of irritation were reversible within the observation period in all except one female animal.
A slight weight loss was recorded for 1 out of 5 female animals during the first week, but all of the female animals showed weight gain during the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded. The male animals showed weight gain during the first and the second week of the observation.
No abnormalities were noted at necropsy.
The acute dermal medial lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Acute oral toxicity:
Acute oral toxicity In a key acute oral toxicity study with the test item the LD50 was >2000 mg act.ingr. /kg bw for female rats. There were no clinical obervations or changes in body weight or macroscopic pathology
Acute dermal toxicity:
In a key acute dermal toxicity study with the test item the LD50 was >2000 mg act.ingr. /kg. for male and female rats. There were no signs of toxicity and no deaths. Signs of skin irritation (very slight erythema - barely perceptible) on the application site were observed in 5 of 5 male and 5 of 5 female animals. All animals gained the expected body weight throughout the whole experimental period and did not elicit gross pathological findings. LD50 was > 2000 mg/kg bw.
Acute inhalation toxicity:
Intoxication due to acute inhalation exposure of industrial workers or even the acute inhalation exposure as such is very unlikely for the test item due to low vapour pressure and application of the substance (aqueous emulsion). Based on these and other physicochemical properties, the inhalation and dermal route are not appropriate, and the default oral route of administration is most appropriate (ECHA R7a Guidance p 342). Additional inhalation testing would therefore neither lead to a better risk assessment, nor improve the safety of applications. On the basis of the argumentation summarized above an acute inhalation toxicity is waived.
Justification for selection of acute toxicity – oral endpoint Key study
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