Registration Dossier
Registration Dossier
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EC number: 276-771-4 | CAS number: 72705-26-1
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity
The acute oral LD50 was determined to be > 2000 mg/kg bw.
Acute dermal toxicity
The acute dermal LD50 was determined to be > 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline compliant study
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline compliant study
Additional information
Acute oral toxicity
Key study
In an acute oral toxicity study performed according to GLP and the OECD 423 Acute Toxic Class method, 2000 mg/kg of the test substance (preparations in corn oil Ph.Eur.) were administered by gavage to two test groups of three fasted Wistar rats each (6 females). The animals were observed for 14 days.
No mortality occurred and no clinical signs were observed.
The body weight of the animals increased within the normal range throughout the study period with one exception. In one animal the body weight increased normally during the first week, but this animal only slightly gained weight during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.
There were no macroscopic pathological findings at the end of the observation period.
The acute oral LD50 was determined to be > 2000 mg/kg bw.
Acute dermal toxicity
Key study
In a GLP and OECD 402 guideline compliant acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the test substance (as suspension in corn oil Ph.Eur.). The clipped application site (dorsal and dorso-lateral parts of the trunk, comprising at least 10% of the total body surface), was covered by semi-occlusive dressing during the 24-hour exposure period. The animals were observed for 14 days. In the study no mortality occurred and no clinical signs were observed.
The following test item-related local effects were recorded on the first two days after application: Yellowish discoloration of the application area in all animals.
The body weight of the male animals increased within the normal range throughout the study period. The body weight of the female animals increased in two animals within the normal range throughout the study period. Three female animals showed stagnation of body weight during the first week, while these animals gained weight in a normal range during the second week. As stagnation of body weight is generally known to occur as a consequence of the dermal application procedure, the body weight stagnation observed is considered to be unspecific.
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 > 2000 mg/kg bw.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
Acute oral toxicity
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). The LD50 for acute oral toxicity was greater 2000 mg/kg bw. As a result the test substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
Acute dermal toxicity
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). The LD50 for acute dermal toxicity was greater 2000 mg/kg bw. As a result the test substance is not considered to be classified for acute dermal toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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