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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydro-2-isobutyl-4-methyl-2H-pyran
EC Number:
236-770-1
EC Name:
Tetrahydro-2-isobutyl-4-methyl-2H-pyran
Cas Number:
13477-62-8
Molecular formula:
C10H20O
IUPAC Name:
4-methyl-2-(2-methylpropyl)oxane
Details on test material:
Name of the test substance used in the study report: Dihydrorosenoxid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: THOMAE GMBH, Biberach, Germany
- Weight at study initiation: 180-188g (males), 169-187g (females)
- Fasting period before study: 16 hours before test substance administration
- Housing: Five animals per cage (type: stainless steel wire mesh cages, DK-III).
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% in water
Details on oral exposure:
Concentrations used: 21.5, 31.6 and 50% (w/v)
Administration volume: 10 ml/kg
Doses:
2150, 3160 and 5000 mg/kg
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 (clinical signs: several times on application day, daily during workdays; mortality: several times on application day, 2 times daily during workdays, once daily during holidays) and weighing (d0, d2, d3, d7, d13)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Males:
2150 mg/kg: 0/5
3160 mg/kg: 0/5
5000 mg/kg: 0/5

Females:
2150 mg/kg: 0/5
3160 mg/kg: 0/5
5000 mg/kg: 1/5 (d7)
Clinical signs:
other: 2150 mg/kg: no symptoms 3160 mg/kg: no symptoms 5000 mg/kg: Dyspnea, apathy, abnormal position (females only), staggering, ruffled fur (females only), exsiccosis (females only), poor general state
Gross pathology:
Animal that died: acute congestive hyperemia; liver: extreme remarkable peripheral broadened lobular pattern; liver overall grey (degeneration)
Sacrificed animals: organs: nothing abnormal detected

Applicant's summary and conclusion