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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-08-25 to 2004-10-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study, without quality assurance, but conducted in GLP facilities. No reference to OECD guideline. Brief summary report, limited experimental details reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD 430
Deviations:
yes
Remarks:
OECD Guideline not mentioned, instead: SPL Standard Test Method 557.02. Incomplete documentation of experimental details.
GLP compliance:
no
Remarks:
The study was conducted in a facility operating to GLP (within UK national GLP programme), but the report was not audited by the Quality Assurance unit.

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4,5-oxadiazepane
EC Number:
616-123-3
Cas Number:
746595-79-9
Molecular formula:
C4H10N2O
IUPAC Name:
1,4,5-oxadiazepane

Test animals

Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
TEST ANIMAL
- Age at study initiation: young

Test system

Preparation of test site:
other: Skin discs obtained from the prepared pelt of a humanely killed young Wistar rat, after integrity test for acceptability of the pelt.
Vehicle:
unchanged (no vehicle)
Remarks:
Liquid test material, no vehicle reported
Controls:
other: further skin discs from the same animal
Amount / concentration applied:
Not reported
Duration of treatment / exposure:
24 hours
Observation period:
2 hours, in the presence of sulforhodamine B dye
Number of animals:
One untreated animal for the preparation of the required number of skin discs
Details on study design:
Test material applied to the epidermal surface of three skin discs for 24 hours (amount not reported).
Removal of test material using a jet of warm tap water at the end of the contact period.
Measurement of the inherent transcutaneous electrical resistance (TER) by means of a low voltage alternating current electronic databridge.
Subsequent assessment of dye penetration:
After application of 150 microliters of a 10% w/v solution of sulforhodamine B to the epidermal surface of the discs for 2 hours, followed by washing with a jet of tap water to remove unbound dye, the bound dye content per disc was quantified from optical density values.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
transcutaneous electrical resistance (in kΩ)
Value:
2.6
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 24 hours. Reversibility: other: not applicable. Remarks: TER 2.6 +/- 0.6 kOhm.
Irritation / corrosion parameter:
dye content (µg/disc)
Value:
44.7
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 24 + 2 hours. Reversibility: other: not applicable. Remarks: 44.70 microgram/disc, vs 40.53 microgram/disc for positive control .

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
in vitro
Executive summary:

In a Transcutaneous Electrical Resistance (TER) test, the test material caused an inherent TER of 2.6 kOhm, i.e. less than the OECD 430 threshold value of 5 kOhm.

This was confirmed by a sulforhodamine B dye binding value of 44.70 microgram/disk, which is higher than the binding caused by the positive control (40.53 microgram/disc). The dye binding of the control discs (12.64 microgram/disc) was below the values requested by OECD 430, which proves the integrity of the pelt.

According to OECD 430, the test substance is considered to be corrosive to skin.