Registration Dossier

Administrative data

Description of key information

LD50(oral) = 4752 mg/kg bw. (BASF, 1981)
LD50(dermal) > 2000 mg/kg bw (Bioassay, 2013)
LC0(inhalation) = 0.11 mg/L (BASF, 1981); no mortalilty occured at this dose level.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity:

The test substance was tested in an acute oral toxicity study comparable to OECD guideline 401 (BASF, 1981). The test substance was applied to five male and five female Sprague-Dawley rats per dose group at doses of 2150, 3160, 5000, 6810 and 10000 mg/kg bw. The animals were observed for 14 days and animals were observed daily for clinical signs and mortality. Weighing was performed on day 0, day 2-4, day 7 and day 13. After 14 days, the surviving animals were subjected to a gross pathological examination. Animals that died were examined as quickly as possible. The following mortalities were observed: 2150 mg/kg: no deaths; 3160 mg/kg: 2/5 males and 0/5 females died; 5000 mg/kg: 2/5 males and 2/5 females died; 6810 mg/kg: 5/5 males and 4/5 females died; 10000 mg/kg: all animals died. Observed clinical signs included: dyspnea, stertor, apathy, abnormal position, staggering, paresis (hind leg), spastic gait, piloerection, erythema, exsiccosis, exophthalamus, salivation, blood (in the nose and/or in the urine), poor general state. Not all clinical signs were observed in all dose groups. The surviving animals gained weight as expected. Upon gross pathological examination the following findings were made in animals that died: Heart: acute atrial dilatation; acute congestive hyperemia; stomach: diffuse reddening of true stomach; intestines: atonic, mucosal reddening, diarrhea and hematinic contents. Nothing unusual was observed in animals that were sacrificed at the end of the observation period. An oral LD50 (males and females) was calculated to be 4752 mg/kg bw.

Acute inhalation:

In a standardized inhalation hazard test with a saturated vapour atmosphere, 0/12 rats died after 7 h exposure (BASF, 1981). The test was performed in principle as described in OECD test guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at 20 °C. Young adult laboratory rats, 6 per sex, were exposed sequentially to the vapors generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 7 h. The exposure was subsequently repeated in the same manner. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during exposure, and the amount of air used during exposure.The LC0 is 0.11 mg/l air for male and female rats. No clinical signs and no signs of local respiratory irritation were observed. All animals gained weight as expected and no mortalities occured. Necropsy was inconspicuous.

Acute dermal toxicity:

In an acute dermal toxicity study (Limit Test, according to OECD 402 and GLP), young adult Wistar rats (5 males and 5 females)were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted Korantin MAT to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi- occlusive dressing for 24 hours (Bioassay, 2013). The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

The following test item-related clinical signs and local effects were recorded during the course of the study:

- No mortality occurred
- No signs of systemic toxicity

- Very slight to well-defined erythema (grade 1 to 2)

- The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range.
- No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
Accordingly, the acute dermal median lethal dose (LD50) in the rat was determined to be > 2000 mg/kg bw.

 

Justification for classification or non-classification

Based on the available acute toxicity studies, the substance was neither classified according to Directive 67/548/EEC nor according to CLP.