1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No OECD Guideline study but according to accepted scientific standards at time of performance, sufficiently documented and no unacceptable deviations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

Sufficient documentation to accept data

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octopirox

IUPAC Name:

Octopirox

Constituent 2

Reference substance name:

Piroctone olamine

IUPAC Name:

Piroctone olamine

Constituent 3

Reference substance name:

1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

EC Number:

272-574-2

EC Name:

1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

Cas Number:

68890-66-4

Molecular formula:

C14H23NO2.C2H7NO

IUPAC Name:

1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

Constituent 4

Reference substance name:

1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt

IUPAC Name:

1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 84 - 110 g
- Diet (e.g. ad libitum): Altromin 1324 ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: Yes


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

- Concentration in vehicle: 25%

Doses:

4000 / 6300 / 7100 / 8000 / 9000 / 10000 / 15000 mg/kg body weight

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations once daily / Weighing once weekly
- Necropsy of survivors performed: yes

Statistics:

Probit analysis

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

8 100 mg/kg bw

Mortality:

see table 1

Clinical signs:

other: disequilibrium, dyspnoe, convulsions

Gross pathology:

Dissection of rats killed at the end of the observation period revealed no macroscopic findings

Any other information on results incl. tables

Table 1: Mortality

Dose (mg/kg body weight)	Mortality rate
4000	0 / 10
6300	0 / 10
7100	1 / 10
8000	7 / 10
9000	6 / 10
10000	10 / 10
15000	10 / 10

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The median lethal dose of Piroctone Olamine (LD50) was 8100 (7660-8570) mg per kg body weight. Based on the result of this study Piroctone Olamine is not subject for labelling and classification requirements according to regulatory requirements

Executive summary:

The acute oral toxicity of Octopirox was investigated in rats using suspensions in sesame oil at a concentration of 25%. 10 female SPF-Wistar rats each were administered Octopirox by single-dose gavage at dose levels of 4000, 6300, 7100, 8000, 9000, 10000 or 15000 mg/kg body weight and were observed for 14 days. After application the animals showed the following symptoms: Disequilibrium, dyspnoe and convulsions. Gross pathology of lethally intoxictaed rats as well as of all rats at the end of the observation period revealed no remarkable macroscopic findings. The median lethal dose (LD50) was calculated to be 8100 mg/kg body weight.