Reaction mass of 6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran and 2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran and 2-butyltetrahydro-6-methyl-4-methylene-2H-pyran

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

16 June - 30 June, 1980

Reliability:

4 (not assignable)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Remarks:

This study was conducted in compliance with the FDA's Good Laboratory Practices effective 6/20/79.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran

EC Number:

246-099-6

EC Name:

2-butyl-3,6-dihydro-4,6-dimethyl-2H-pyran

Cas Number:

24237-01-2

Molecular formula:

C11H20O

IUPAC Name:

2-butyl-4,6-dimethyl-3,6-dihydro-2H-pyran

Constituent 2

Reference substance name:

6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran

EC Number:

246-098-0

EC Name:

6-butyl-3,6-dihydro-2,4-dimethyl-2H-pyran

Cas Number:

24237-00-1

Molecular formula:

C11H20O

IUPAC Name:

6-butyl-2,4-dimethyl-3,6-dihydro-2H-pyran

Constituent 3

Reference substance name:

2-butyltetrahydro-6-methyl-4-methylene-2H-pyran

EC Number:

246-101-5

EC Name:

2-butyltetrahydro-6-methyl-4-methylene-2H-pyran

Cas Number:

24237-02-3

Molecular formula:

C11H20O

IUPAC Name:

2-butyl-6-methyl-4-methylenetetrahydro-2H-pyran

Specific details on test material used for the study:

Material Identification (as stated in the report) : Gyrane #80-38
Appearance: Clear liquid
Sample received on 06/02/80

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: 202 - 268 g
- Fasting period before study: 16-20 hours
- Housing: Five animals per cage were housed in suspended wire mesh cages.
- Diet: Fresh Purina rat chow was freely available
- Water: Water was freely available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test arzicle was given by orally by syringue and a dosing needle.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: the animals were observed 3-4 hours after dosing and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and clinical signs, gross pathology.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

One instance of chromodacryorrhea was noted 3-4 hours post dose.
Isolated instances of hyperactivity, prostration, piloerection, ptosis, tachypnea and chromodacryorrhea were noted during the study. Nine animals were normal on day 14.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity with male Wistar rats performed equivalent to OECD 401 guideline, a LD50 >5000 mg/kg bw was determined.

Executive summary:

Gyrane was tested in an acute oral toxicity study with male Wistar rats at 5000 mg/kg body weight. The study was performed equivalent to OECD 401 guideline and according to GLP principles.

No mortality occurred in 10 male rats from an oral dose of Gyrane, at 5.0 g/Kg. Minimal toxic signs were present and the necropsy findings were normal.

Thus, the LD50 of Gyrane was determined to be : LD50>5000 mg/kg bw.