N,N'-diacetylhydrazine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

from 2004-03-15 to 2004-03-25 (experimental phase)

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study is a screening study which 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. All raw data (observations) were reported. Although the results are considered valid, the screening study itself cannot be considered formally reliable due to the lack of 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

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

Details on test material:

Test material characterisation data were the responsibility of the Sponsor.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No details on test animals and environmental conditions are reported.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (81 mg)

Duration of treatment / exposure:

single application

Observation period (in vivo):

Ocular reactions were recorded 1, 24,48 and 72 hours after administration.

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: not reported

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: mean score at 24, 48 and 72 hours

Score:

0

Max. score:

110

Results 2

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

other: mean of scores at 24, 48 and 72 hours

Score:

0.67

Max. score:

110

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

other: mean of scores at 24, 48 and 72 hours

Score:

0.67

Max. score:

110

Reversibility:

fully reversible within: 48 hours

Any other information on results incl. tables

Individual Scores and Individual Total Scores for Ocular Irriation

Rabbit number and sex	38 Male				52 Male				157 Male
	Initial Pain Reaction = 3				Initial Pain Reaction = 0 *				Initial Pain Reaction = 0 *
Time after treatment [h]	1	24	48	72	1	24	48	72	1	24	48	72
Cornea
E=Degree of Opacity	0	0	0	0	0	0	0	0	0	0	0	0
F=Area of Cornea involved	0	0	0	0	0	0	0	0	0	0	0	0
Score (E x F x 5)	0	0	0	0	0	0	0	0	0	0	0	0
Iris
D	0	0	0	0	0	0	0	0	0	0	0	0
Score (D x 5)	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctivae
A=Redness	1	0	0	0	1	1	0	0	1	1	0	0
B=Chemosis	0	0	0	0	0	0	0	0	0	0	0	0
C=Discharge	1	0	0	0	1	0	0	0	1	0	0	0
Score (A + B + C) x 2	4	0	0	0	4	2	0	0	4	2	0	0
Total Score	4	0	0	0	4	2	0	0	4	2	0	0

* One drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not considered to be an eye irritant according to the criteria set out in Regulation (EC) No 1272/2008. Although the result is considered to be valid, due to the lack of quality assurance, and very limited documentation, it should be regarded as not being reliable.

Executive summary:

A study was preformed to assess the irritation of the test material to the eye of rabbits. The method followed OECD TG 405.

A single application of 0.1 mL (81 mg) test material was administered to the non irrigated eye of three rabbits. Ocular reactions were recorded 1, 24, 48 and 72 hours after administration.

The test material produced minimal conjunctival irritaiton. All treated eyes appeared normal at the 48-hour observations.