1,4,5-Oxadiazepine, hexahydro-

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

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.

Results 2

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.