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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-11-11 until 1997-11-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientifically valid study according to GLP and current OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
, adopted 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
, adopted 1992
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
oxolane-3-carbaldehyde
EC Number:
629-664-5
Cas Number:
79710-86-4
Molecular formula:
C5 H8 O2
IUPAC Name:
oxolane-3-carbaldehyde
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd, Hollister, CA
- Age at study initiation: 8 - 11 weeks
- Weight at study initiation: males: 273 - 297 g; femals: 224-252 g
- Housing: singly, suspended, stainless-steel, wire mesh cages
- Diet: Certified Rodent Diet (Purina Roden Chow #5002, pellets, ad libitum
- Water: drinking water, ad libitum, regulary analysed
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-22°C
- Humidity: 49-50 %
- Photoperiod: 12 hours of artificial light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal skin region
- % coverage: not less than 10 %
- Type of wrap if used: fiber pad and an occlusive wrap.

REMOVAL OF TEST SUBSTANCE
- Washing: using running water
- Time after start of exposure: 24 hours

TEST MATERIAL AND VEHICLE
The test substance was administered at a dose level of 2000 mg/kg bw

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 animals: 5 males, 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: systemically between days 0-14, body weights were recorded on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

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 adverse effects noted
Mortality:
No mortality was observed.
Clinical signs:
other: There were no signs of systemic reaction to treatment. There were no signs of systemic toxicity.
Gross pathology:
No abnormalities were noted.
Other findings:
none

Applicant's summary and conclusion