Reaction mass of rel-(2S,4R,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane and rel-(2S,4S,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No information on purity was given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

no information on purity, no constant dose volume applied

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

reaction mass of rel-(2S,4R,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane and rel-(2S,4S,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane

EC Number:

945-924-3

Molecular formula:

C13H18O2

IUPAC Name:

reaction mass of rel-(2S,4R,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane and rel-(2S,4S,6S)-2,4,6-trimethyl-4-phenyl-1,3-dioxane

Test animals

Species:

rat

Strain:

Wistar

Remarks:

SPF-WIstar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150 - 180 g
- Fasting period before study: 16 h
- Housing: individually
- Diet: Standard diet (Ssniff/Intermast), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%

DOSE VOLUMES APPLIED:
0.794 mL/kg bw: 0.49 - 0.51 mL
1.0 mL/kg bw: 0.60 - 0.72 mL
1.26 mL/kg bw: 0.78 - 0.83 mL
1.59 mL/kg bw: 0.96 - 1.1 mL

Doses:

0.794, 1.0, 1.26 and 1.59 mL/kg bw equivalent to 0.810, 1.02, 1.29 and 1.62 g/kg bw (based on a relative density of 1.02)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were noted 20 min, 1, 3 and 24 hours after dosing and on Days 7 and 14. Body weight was determined before the application (Day 0) and on Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

LD50 was calculated by Probit analysis (Finney, 1971).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Remarks:

calc.

Effect level:

1.24 mL/kg bw

Based on:

test mat.

95% CL:

>= 1.16 - <= 1.32

Remarks on result:

other: equivalent to 1.26 g/kg bw

Mortality:

0.794 mL/kg bw dose group: no mortality occurred
1.0 mL/kg bw dose group: 3 females died
1.26 mL/kg bw dose group: 4 females died within 4 days
1.59 mL/kg bw dose group: 4 males and 5 females within 3 days

Clinical signs:

other: Coordination disorder, attitude and positon anomaly, reduced or lack of the righting-reflex, grip reduction, hyperaemia, piloerection, decreased respiratory frequency and ptosis were detected 10 min after application and persisted partly longer than 24 ho

Gross pathology:

Reddening of the intestinal mucosa and the stomach lining was found in the moribund animals. In the surviving animals no pathological findings were noted.

Applicant's summary and conclusion

Interpretation of results:

other: Acute Tox. Cat. 4

Remarks:

according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in male and female rats a LD50 value of 1.24 mL/kg bw was found.