potassium (oxido-NNO-azoxy)cyclohexane; cyclohexylhydroxydiazene 1-oxide, potassium salt; [K-HDO]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: The investigations were carried out according to D. N. Noakes and D. M. Sanderson (A method for determining the dermal toxicity of pesticides: Brit. Journ. Ind. Med. 26, 1969)

Deviations:

not specified

Principles of method if other than guideline:

- Principle of test:Measurement of the percutaneous LD50 of a pesticide, using the laboratory rat as a test animal.
- Short description of test conditions: the product was applied once as a 50% strength formulation in distilled water at a dosage of 2,500 mg/kg for 24 hours to the clipped skin of the back and flanks (area about 50 cm²)
- Parameters analysed / observed: percutaneous LD50 value

GLP compliance:

not specified

Remarks:

GLP was not compulsory at the time the study was performed however the study has been performed under consideration of good laboratory practice. The study is scientifically valid.

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexylhydroxydiazene 1-oxide, potassium salt

EC Number:

613-953-8

Cas Number:

66603-10-9

Molecular formula:

C6H11KN2O2

IUPAC Name:

Cyclohexylhydroxydiazene 1-oxide, potassium salt

Test material form:

solid: particulate/powder

Details on test material:

Test item: (N-Cyclohexyl-diazeniumdioxy)-potassium
IUPAC name: Cyclohexylhydroxydiazene 1-oxide, potassium salt
Chemical name: Cyclohexylhydroxydiazene 1-oxide, potassium salt; synonyma: (N-Cyclohexyl-diazeniumdioxy)-potassium, K-HDO, K-NCH, Xyligen K powder, Xyligen K
Molecular formula: C6 H11 K N2 O2
Molecular mass: 182.27

Specific details on test material used for the study:

Chemical name: N-cyclohexyldiazeniumdioxy potassium
Test substance no.: XXV 210
The product was applied as a 50% strength formulation in distilled water at a dosage of 2500 mg/kg

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. WIGA, Sulzfeld, FRG
- Females (if applicable) nulliparous and non-pregnant: yes
- Age / Weight at study initiation: male animals: 157 g (mean weight); female animals: 139 g (mean weight)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: about 50 cm²
- Type of wrap if used: aluminum foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing with warm water or a mixture of water and lutrol
- Time after start of exposure: The dressing was removed after the exposure time of 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2500 mg/kg
- Concentration (if solution): The product was applied as a 50% strength formulation in distilled water
- Constant volume or concentration used: yes

VEHICLE
- distilled water

Duration of exposure:

24 hours

Doses:

2500 mg/kg

No. of animals per sex per dose:

5 animals per sex and dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1 h, 24 h, 48 h, 7 days, 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality within 14 days, signs of toxicity due to absorption and local irritation, Necropsy of the animals which were sacrificed with carbon dioxide at the end of the observation period

Statistics:

Determination of median lethal dose

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

The animals were lively during and after the administration and in the 14-day observation period.

Clinical signs:

other: No signs of toxicity observed; local irritation: none

Gross pathology:

Animals which were sacrificed: organs normal.

Other findings:

None observed

Any other information on results incl. tables

Results mortality

			died within
Dose mg/kg	Conc. %	Number of animals	1 h	24 h	48 h	7 days	1 4 days
2500	50	5 m	0/5	0/5	0/5	0/5	0/5
		5 f	0/5	0/5	0/5	0/5	0/5

Applicant's summary and conclusion

Conclusions:

The percutaneous LD50 value of rats is for both sexes above 2500 mg/kg bw. The product is dermally non-toxic at least up to a concentration of 2500 mg/kg bw

Executive summary:

MORTALITY: no mortality
CLINICAL SIGNS: no abnormalities
SKIN FINDINGS: no abnormalities
NECROPSY FINDINGS: no findings
POTENTIAL TARGET ORGANS: no findings at the internal organs
SEX-SPECIFIC DIFFERENCES: no findings

 

Signs of toxicity due to the absorption: The animals were lively during and after the administration and in the 14-days observation period.
Local irritation: none
Necropsy: Animals which were sacrificed: organs normal.
The median lethal dose was > 2500 mg/kg (50%w/w KHDO)/kg bw corresponds to > 1250 mg K-HDO/kg bw