Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 22, 1987 - August 05, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD 401 Guideline, but predating GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
no
Remarks:
Study performed around/just before the time GLP was introduced in Europe, but internal QA statement.
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
EC Number:
700-927-7
Molecular formula:
C17H30O2
IUPAC Name:
Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): PM 968
- Physical state: liquid
- Storage condition of test material: stored at ambient temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent, U.K.
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 103 - 128 g
- Fasting period before study: overnight prior to and approximately 4 hours after dosing
- Housing: Group housed per sex in metal cages with wire mesh floors
- Diet: A standard laboratory rodent diet (Labsure LAD 1) was provided ad libitum
- Water: water was provided ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 68
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.26 mL/kg

Doses:
5000 mg/kg bodyweight
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: Animals were observed soon after dosing at frequent intervals for a Day. On subsequent days the animals were observed once in the morning and again at the end of the experimental day. Clinical signs were recorded at each observation.
- Necropsy of survivors performed: yes, all animals were killed on day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination.
- Body weight: Day 1, 8 and 15.
Statistics:
Not required.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Pilo-erection was observed in all rats shortly after dosing, throughout the remainder of day 1 and on day 2. There were no other clinical signs and recovery, as judged by external appearance and behaviour, was apparently complete by day 3.
Body weight:
Slightly low bodyweight gains were recorded on day 8 for two male and one female rat. Other rats achieved anticipated bodyweight gains throughout the study.
Gross pathology:
No abornormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study with rats, performed according to OECD 401 test guidelines, an LD50 >5000 mg/kg bw was determined.
Executive summary:

The substance was tested in an acute oral toxicity study with Sprague-Dawley rats, performed according to OECD 401 test guideline, but not under GLP.

No deaths occurred. Pilo-erection was observed in all rats shortly after dosing, throughout the remainder of day 1 and on day 2. There were no other clinical signs and recovery was apparently complete by day 3.

Slightly low bodyweight gains were recorded on day 8 for two male and one female rat. Other rats achieved anticipated bodyweight gains throughout the study. At gross pathology no abnormalities were seen.

The LD50 of the substance was established to be >5000 mg/kg bodyweight.