N,N'-diacetylhydrazine

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2004-03-08 to 2004-03-23 (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. 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.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Remarks:

relevant deviations from SOP specifications were not reported

Principles of method if other than guideline:

The study was performed according to the internal standard operational procedure 595.12 of the laboratory, but no details on this SOP are given in the report. The principles of the internal SOP are to the greatest extent similar to those described in OECD Testing Guideline No. 429 (Mouse Local Lymph Node Assay).

GLP compliance:

no

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

other: CBA/Ca

Sex:

not specified

Details on test animals and environmental conditions:

not reported

Vehicle:

dimethyl sulphoxide

Concentration:

2.5, 5 and 10% w/w

No. of animals per dose:

four animals

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: not reported
- Irritation: not reported
- Lymph node proliferation response: not reported
- Other responses: clinical observations, body weight change, mortality

MAIN STUDY
- Criteria used to consider a positive response: stimulation index
- Vehicle control: four animals treated with dimethyl sulphoxide

TREATMENT PREPARATION AND ADMINISTRATION:
- Vehicle: dimethyl sulphoxide
- Application/site: topical on the dorsal surface of ears
- Application volumes: 25 µL per ear

Statistics:

not reported

Positive control results:

no positive control tested

Parameter:

SI

Remarks on result:

other: Vehicle: not applicable 2.5% w/w in dimethyl sulphoxide: 1.01 5% w/w in dimethyl sulphoxide: 1.43 10% w/w in dimethyl sulphoxide: 0.78

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Vehicle: 7571.75 DPM, 946.47 DPM/Node 2.5% w/w in dimethyl sulphoxide: 7665.04 DPM, 958.13 DPM/Node 5% w/w in dimethyl sulphoxide: 10815.94 DPM, 1351.99 DPM/Node 10% w/w in dimethyl sulphoxide: 5933.59 DPM, 741.70 DPM/Node

No signs of systemic toxicity or body weight changes and no mortality were observed in the screening test applying a solution of the test substance in dimethyl sulphoxide at a concentration of 10% w/w to the skin surface of the ears.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was considered as a non-sensitiser under the conditions of the Mouse Local Lymph Node Assay. 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 potential for skin sensitisation of the test substance was investigated in a non-GLP mouse local lymph node assay in CBA/Ca mice that was conducted according to principles similar to those given in OECD Testing Guideline No. 429. Following a preliminary sighting test at which there were no deaths or signs of systemic toxicity at a concentration of 10% w/w, three groups, each of four animals, were treated with 50 µL of the test material (25 µL per ear) as a solution in dimethyl sulphoxide at concentrations of 2.5%, 5% and 10% w/w. A further group of four animals was treated with dimethyl sulphoxide alone. The Stimulation Indeces expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle group were 1.01, 1.43 and 0.78 for the groups treated with concentrations of 2.5, 5 and 10% w/w, respectively and hence below the threshold of 3.0 indicating a positive result.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin

Only one study addressing skin sensitisation is available (Pooles 2004f). The test was comparable to OECD TG 429. The test substance was tested under the conditions of the Mouse Local Lymph Node Assay. The study is considered to be relevant. It is regarded as adequate for classification and labelling, but not reliable. Following a preliminary sighting test at which there were no deaths or signs of systemic toxicity at a concentration of 10% w/w, three groups, each of four animals, were treated with 50 µL of the test material (25 µL per ear) as a solution in dimethyl sulphoxide at concentrations of 2.5%, 5% and 10% w/w. A further group of four animals was treated with dimethyl sulphoxide alone. The Stimulation Indices expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle group were 1.01, 1.43 and 0.78 for the groups treated with concentrations of 2.5, 5 and 10% w/w, respectively and hence below the positive result threshold of 3.0.

 

Inhalation

No study available on respiratory sensitisation.

Short description of key information:
- Skin: not sensitising, mouse, similar to OECD 429, Pooles 2004

Justification for selection of skin sensitisation endpoint:
Only study available.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

No information on respiratory sensitisation is available.

Short description of key information:
No information on respiratory sensitisation is available.

Justification for classification or non-classification

Skinsensitisation

The substance showed no potential for skin sensitisation in a mouse LLNA test. Therefore no classification is needed for this endpoint according to commission Directive 2001/59/EC. The classification is not considered conclusive due to the reliability of the study.

 

The substance showed no potential for skin sensitisation in a mouse LLNA test. Therefore no classification is needed for this endpoint according to Regulation (EC) No. 1272/2006, Part 3, 3.2. The classification is not considered conclusive due to the reliability of the study.

 

Respiratory sensitisation

As no studies are available for this endpoint.