Registration Dossier

Administrative data

Description of key information

acute toxicity test, rat oral (BASF AG, 1987): LD50(oral) > 464 mg/kg < 2150 mg/kg
inhalaton hazard test, rat inhalativ (BASF AG, 1987): No mortality occured when rats were exposed to the saturated vapor for 7 hours.
acute dermal toxicity (BASF, 2012): LD50(dermal) > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
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 acute oral toxicity of the test substance was estimated in a test which was conducted comparable to OECD guideline 401. Five wistar rats per sex and dose were fasted for 16 hours while water was available ad libitum. The rats were treated with a single oral administration of 5000, 2150, 464 or 215mg/Kg of the test substance diluted in aqua dest. (vehicle) by gavage. During the following 14 days the rats' clinical signs and symptoms were recorded at least once each day. 16 hours before the end of the 14 days observation time the rats were fasted for 16 hours, sacrified with CO2 and gross-pathologically examined. A necropsy of the animals died before the end of the study was peformed as early as possible. All male and female animals treated with 5000 or 2150mg/Kg died after one day. 2/5 male animals treated with 464mg/Kg died after 7 days. The animals dosed with 5000 mg/Kg developed dyspnea, apathy, abnormal position, atonia, paresis, poor general state, staggering, exsiccosis, and piloerection within the first 4 hours after the application. The animals dosed with 2150 mg/Kg developed dyspnea, apathy, staggering, abnormal position, atonia, paresis, poor general state, staggering, and piloerection (only females) within the first 4 hours after the application. Furthermore animals dosed with 464 mg/Kg developed dyspnea, apathy, staggering (only males), and poor general state 3 days after the application. Male and female animals died spontaneously on day 1 or 7 showed general congestion, yellow brown liver lobular perphery , and bloody ulcerations in the glandular stomach while animals sacrified after the end of the study did not show any pathological findings. The LD50 for male rats was estimated to be 464mg/Kg since 2/5 animals of this dose group died after 7 days. 5/5 femal animals treated with 2150mg/Kg died after 1 day while 5/5 animals treated with the next lower dose of 464mg/Kg survived until the end of the study. Therefore the LD50 of female rats was assessed to be > 464mg/Kg and < 2150mg/Kg.

Acute inhalation toxicity:

The acute inhalation toxicity of the test substance was estimated using the BASF-Test Protocol which is in principle consistent with OECD guideline 403. The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (20 °C). Three rats per sex were exposed to the vapours, generated by bubbling 200l/h air through a substance column of about 5 cm above a fritted glassdisc in a glass cylinder. After 30 minutes this column was replaced by a new column filled with fresh test substance which was used unil the end of the exposure time. The total exposure time was 7h and the mean concentration of the test substance during this time was 5.1mg/l. Clinical signs were documentated daily over a period of 14 days after exposure with the test substance and a necropsy was performed at the end of the study. During the exposure of the substance the animals showed mopping of the snout, red nose discharge, and delayed pain reflexes. After the exposure time some animals had bloody nose discharge which showed the substance's irritating potential. All animals survived until the end of the study and did not develop pathological findings. Therefore the LD50 of the test material is > 5.1mg/l as the maximum achievable vapor concentration in this test.

Acute dermal toxicity:

In an acute dermal toxicity study according to OECD 402 guideline and GLP (BASF, 2012), young adult Wistar rats were dermally exposed to

doses of 2000 mg/kg and 500 mg/kg bw of 2-Propyn-1-ol, compd. with methyloxirane (as a solution in deionized water or undiluted) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area.

The animals were observed for 14 days (2000 mg/kg: 5 males and 5 females; 500 mg/kg: 5 males and 5 females).

The following test item-related effects were recorded:

· No mortality occurred

· No signs of systemic toxicity or skin effects were observed in the animals

· The mean body weight of the male animals increased throughout the study period within the normal range (2000 mg/kg bw: 5 males; 500 mg/kg bw: 5 males)

· The mean body weights of the female animals stagnated during the first postexposure observation week probably due to the bandage procedure, but increased during the second week within the normal range (2000 mg/kg bw: 5 females; 500 mg/kg bw: 5 females)

· No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study

Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the acute oral toxicity study, the test substance was classified as harmfull if swallowed (R22) according to EU directive 67/548/EEC and (Cat. 4, oral) EU classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Based on the inhalation hazard test, classification for acute inhalation toxicity is not warranted according to EU directive 67/548/EEC and EU classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Based on the acute dermal toxicity study, classification of the test substance is not warranted according to EU directive 67/548/EEC and EU classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.