Registration Dossier

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: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydro-4-methylene-2-(2-methyl-1-propenyl)-2H-pyran
EC Number:
262-475-2
EC Name:
Tetrahydro-4-methylene-2-(2-methyl-1-propenyl)-2H-pyran
Cas Number:
60857-05-8
Molecular formula:
C10H16O
IUPAC Name:
4-methylidene-2-(2-methylprop-1-en-1-yl)oxane

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
Groups of 3 animals were held in stainless steel cages (31 cm x 46 cm x 19 cm) in rooms with air-condition (temperature 20 +/- 2°C, relative humidity 50 +/- 20%). The day/night rhythm was 12 h dark and 12 h night.
A standardized animal laboratory diet as well as drinking water were offered.

TEST ANIMALS
- Source: JANVIER supplier (France)
- Age at study initiation: about 7 weeks
- Acclimation period: at least 5 days
- Fasting period before study: yes

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The animals, fasted prior to the test substance administration, were weighed again on D1 before administration.
The volume per kg of body weight, defined according to the test substance density (= 0.88) as equal to 2.27 ml/kg, the volumes of test substance were calculated for each rat.
After administration, animals were fasted for 3 to 4 hours.
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once a day for clinical signs; before test substance administration and 3, 7 and 14 days after administration for body weights
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
other: Slight toxicity signs were observed during the first 4 hours following treatment (piloerection and reduced motor activity in all the animals sometimes associated to hypotonia or porphyrin deposits around the muzzle); these signs have totally disappeared
Gross pathology:
No organ or tissue lesion macroscopically visible was found during the post mortem examination performed in all the animals 14 days after treatment.

Applicant's summary and conclusion