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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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:
other: Erythema was seen one day after application. No other symptoms observed.
Gross pathology:
No abnormalities detected.
Moribund male showed general hyperemia, which was not considered substance related.

Applicant's summary and conclusion