Registration Dossier

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:
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
Body weight:
No evident effects observed
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