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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
Reference substance name:
reaction mass of 2,4,6-trimethyl-4-phenyl-1,3-dioxane isomer 1 and 2,4,6-trimethyl-4-phenyl-1,3-dioxane isomer 2
EC Number:
945-924-3
Molecular formula:
C13H18O2
IUPAC Name:
reaction mass of 2,4,6-trimethyl-4-phenyl-1,3-dioxane isomer 1 and 2,4,6-trimethyl-4-phenyl-1,3-dioxane isomer 2

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:
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 hours. Afterwards all surviving animals appeared normal.
Body weight:
All animals showed the expected gains in body weight at the end of the study period.
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.