N,N'-diacetylhydrazine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

from 2004-03-09 to 2004-03-17 (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. Compared to a similar guideline method, a reduced number of animals were tested, a reduced observation period used, and the purity of the test material was not reported. 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 402 (Acute Dermal Toxicity)

Deviations:

yes

Principles of method if other than guideline:

A standard test method from the performing test facility was followed. The test was comparable to OECD TG 402. However, only 4 animals were tested and the observation period was only 9 days.

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 type:

standard acute method

Limit test:

yes

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

Details on test material:

Test material characterisation data were the responsibility of the Sponsor.

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

No details on test animals and environmental conditions are reported.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE: intact skin

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 males, 2 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 8 days
- Frequency of observations and weighing:
Weighing: day of dosing, day 1 and day 8
Clinical observations and mortality: 0.5, 1, 2, 4 hours after initiation of exposure, 1, 2, 3, 4, 5, 6, 7, 8 days after initiation of exposure
Dermal reaction: 1, 2, 3, 4, 5, 6, 7, 8 days after initiation of exposure
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality, body weight, dermal reactions

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity or dermal irritation were noted.

Gross pathology:

No abnormalities were detected.

Any other information on results incl. tables

Individual bodyweights and weekly bodyweight changes

Dose Level mg/kg	Animal number and sex	Bodyweight (g) at day			Bodyweight change day 1 to day 8
		Day 1	Day of dosing	Day 8
2000	1-0 male	215	231	296	81
	1-1 male	231	240	303	72
	2-0 female	218	216	244	26
	2-1 female	206	212	232	26

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat strain was found to be greater than 2000 mg/kg bodyweight. 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 study was performed to estimate the toxicity of the test material following a single dermal administration in the Sprague-Dawley CD strain rat.

A group of four animals (two males and two females) was given a single, 24-hour, semi-occluded dermal application of test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths. No signs of systemic toxicity or dermal irritation were noted. 3 out of 4 animals lost weight from the day of dosing to day 1 but alll animals gained weight from the day of dosing to day 8. At necropsy, no abnormalities were detected. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat strain was found to be greater than 2000 mg/kg bodyweight.