N,N'-diacetylhydrazine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

from 2004-02-26 to 2004-03-02 (experimental phase)

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study is a screening study which did not formally follow a guideline method, and was not formally performed under audited GLP, however, the laboratory facilities were operated according to GLP. The purity of the test material was not reported and the documentation in the report was very limited. Although the results are considered valid, the screening study itself cannot be considered formally reliable due to the lack of formal guideline, quality assurance, and very limited documentation.

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:

OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))

Deviations:

no

GLP compliance:

no

Remarks:

This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-diacetylhydrazine

EC Number:

221-576-1

EC Name:

N,N'-diacetylhydrazine

Cas Number:

3148-73-0

Molecular formula:

C4H8N2O2

IUPAC Name:

N'-acetylacetohydrazide

Test material form:

not specified

Test animals

Species:

rat

Strain:

Wistar

Test system

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not reported

Details on study design:

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

SCORING SYSTEM: The substance is considered likely to be corrosive in vivo if the mean electrical resistance is below 5kΩ.

Results and discussion

In vivo

Results

Irritation parameter:

other: electrical resistance (kΩ)

Basis:

mean

Time point:

other: 24 hours

Score:

29.6

Remarks on result:

other: Standard deviation: 4.7 kΩ. Values below 5kΩ are considered to be corrosive.

Irritant / corrosive response data:

The measured mean electrical resistance was 29.6 ± 4.7 kΩ.

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive (skin corrosive category 1)

Conclusions:

Although the result is considered to be valid, due to the lack of formal guideline and quality assurance, and very limited documentation, it must be regarded as not being reliable.

Executive summary:

The skin corrosivity potential of the test material was assessed using the Transcutaneous Electrical Resistance Assay (TER). This involved the application of the test material to the epidermal surface of skin discs, obtained from a humanely killed young Wistar strain rat.

The prepared pelt from the rat was used for skin disc preparation. The test material was applied to the epidermal surface of three skin discs for a contact period of 24 hours. At the end of the contact period the test material was removed using a jet of warm tap water. Corrosive substances produce an irreversible loss of normal stratum corneum integrity and function, this is measured as a reduction in the inherent TER. A threshold value has been established (5 kΩ) below which materials are considered likely to be corrosive in vivo. The TER was measured using a low voltage alternating current electronic databridge.

The measured mean electrcal resistance was 29.6 ± 4.7 kΩ and thus, the test material was considered not to have the potential to be corrosive to the skin in vivo under the conditions of the test.