Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
No signs of toxicity observed; local irritation: none
Body weight:
not mentioned in the study
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