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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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