Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducting according to OECD method by a GLP accredited laboratory.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
EEC Directive 84/449/EEC (OJ No. L251, 19.09.84), Part B, Method B1
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
EC Number:
412-450-9
EC Name:
A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
Cas Number:
131766-73-9
Molecular formula:
C11H20O3
IUPAC Name:
reaction mass of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Groups of 10 Sprague-Dawley rats (Crl CD (SD) BR VAF plus strain) aged 4-6 weeks and weighing 108-152 g. The animal room temperature was 21-23°C with a mean relative humidity of 57% and a light photoperiod of 12 hours. The rats were housed in groups (up to 5 rats) by sex, were fed a standard rat diet, received water ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The rats were fasted overnight and gavaged with a single dose of undiluted test substance. Initially, only the mid-dose group was treated; however, based on the findings, the low- and high-dose groups were treated about one week later.
Doses:
3.2, 5.0, or 8.0 g/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
The rats were observed up to 14 days following treatment and at frequent intervals on day 1 (day of dosing) and twice daily thereafter for clinical signs which were recorded. Body weights were recorded on days 1, 8, and 15. All rats surviving to the end of the observation period were killed on day 15 by cervical dislocation and examined macroscopically (i.e., opening of the abdominal and thoracic cavities).
Statistics:
The LD50 was calculated using probit analysis.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
4 300 mg/kg bw
Based on:
test mat.
95% CL:
> 2 800 - < 6 100
Sex:
male
Dose descriptor:
LD50
Effect level:
4 700 mg/kg bw
Based on:
test mat.
95% CL:
> 3 200 - < 7 000
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 500 mg/kg bw
Based on:
test mat.
95% CL:
> 3 300 - < 5 800
Mortality:
3.2 g/kg bw: male: 3 of 5 deaths, female: 2 of 5 deaths. Rats died within 2 days.
5.0 g/kg bw: male: 2 of 5 deaths, female: 2 of 5 deaths. Rats died within 2 days.
8.0 g/kg bw: 10/10 deaths, all rats died within 2-4 days.
Clinical signs:
other: Pilo-erection and abnormal body carriage (hunched posture) were observed in all rats within 5 minutes of dosing, and were accompanied at this time by increased salivation in rats dosed at 5 g/kg plus abnormal gait (waddling) and lethargy in rats treated a
Gross pathology:
Terminal autopsy showed no macroscopic abnormalities at all dose levels.
Post mortem examination of rats that died during the study revealed no macroscopic abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance does not require labeling with the risk phrase Risk phrase R22 (DSD) or H-statement H302 (CLP) “Harmful if swallowed”
Executive summary:

The test substance was administered by oral gavage at a dose level of 3.2, 5.0, or 8.0 g/kg body weight. Animals were observed twice daily and their body weights were weekly recorded. Macroscopic examination was performed after sacrifice.

Mortality occurred at all dose levels. Clinical signs included piloerection, hunched posture, waddling, lethargy, decreased respiratory rate, ptosis, pallor of extremities, prostration, increased salivation, and increased lacrimation.

The body weight gain of the surviving animals was normal.

No abnormalities were found at post mortem examinations of the animals.

The LD50 of the test substance is 4500 mg/kg body weight. Consequently, the test substance does not need to be classified according to Regulation (EC) 1272/2008 on acute toxicity.