Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

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: mean females: 206 g, males: 247 g
- Housing: individual
- Diet: Kliba-Labordiaet, Fa. Klingentalmuehle AG, Kaiseraugst, Switzerland
- 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

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 50 cm², dorsal and dorsolateral trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not applicable
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

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no substance related deaths occured
Mortality:
One male died on d1. But this death was not considered substance related.
Clinical signs:
Erythema was seen one day after application.
No other symptoms observed.
Body weight:
Normal body weight gain.
Gross pathology:
No abnormalities detected.
Moribund male showed general hyperemia, which was not considered substance related.

Applicant's summary and conclusion