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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from Secondary source.

Data source

Reference
Reference Type:
publication
Title:
Ocular and Dermal Toxicity of Guanidine Nitrate
Author:
US Army Biomedical Research and Development
Year:
1988
Bibliographic source:
IADA198496, updated on July 1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Buehler Dermal Sensitization Test" and EPA guidelines
Principles of method if other than guideline:
To evaluate the skin sensitizing potential of Guanidinnitrate in guinea pig by Buehler test.
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Reference substance name:
Guanidinium nitrate
EC Number:
208-060-1
EC Name:
Guanidinium nitrate
Cas Number:
506-93-4
Molecular formula:
CH5N3.HNO3
Specific details on test material used for the study:
- Name of test material: Guanidinium nitrate
- Molecular formula: CH5N3.HNO3
- Molecular weight: 67.5184 g/mol
- Substance type: Organic
-Purity-95%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA)
- Age at study initiation: 33 days
- Weight at study initiation: 178-225 g at 15 days prior to first induction dose
- Housing: individually in stainless steel, wire mesh cages
- Diet: ad libitum, Certified Purina Guinea Pig Chow Diet 5026 (Ralstone Purina Company, Checkerboard Square, St Louis, MO)
- Water: ad libitum, continuous drip from a central line
- Acclimation period: 15 days before adminisrtation of the first induction dose

ENVIRONMENTAL CONDITIONS
- Temperature: initially 18.9-22.2 °C, increased 22 days after arrival to 20.0-23.3 °C
- Humidity (%): 42-69 % with occasional peaks as high as 88 % during steam line adjustments and room washing
- Air changes (per hr): not specified
- Photoperiod: (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
10%
Day(s)/duration:
24 and 48h following patch removal
Adequacy of induction:
other: concentrations were used to assess the dermal irritation potential
Challenge
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
10%
Day(s)/duration:
24 and 48h following patch removal
Adequacy of challenge:
other: concentrations were used to assess the dermal irritation potential
No. of animals per dose:
10 main test group
10 main test positive control
10 main test negative control
Details on study design:
DOSE RANGE FINDING study
4 animals; 100, 10, 1 and 0.1 % concentrations were used to assess the dermal irritation potential

Main study:
INDUCTION
topical application on the left flank
of 0.5ml of a 10 % solution/suspension in isotonic saline
under a 2.5 cm2 gauze patch for 6h;
three times at intervals of one week;
skin evaluation at 24 and 48h following patch removal

CHALLENGE
treatment and positive control animals: two doses on the left and rigth flank
negative control animals: one dose on the left flank
of 0.5ml of a 10 % solution/suspension in isotonic saline
under a 2.5 cm2 gauze patch for 6h;
one time 2 weeks after the last induction;
skin evaluation at 24 and 48h following patch removal

GRADING SYSTEM
Skin reactions were assigned scores according to the following grading system:
0 no reaction; 1 slight erythema; 2 moderate erythema; 3 marked erythema.
Results are expressed in terms of both incidence (the number of animals showing responses of 1 or greater at either 24 or 48h) and severity (the sum of the test scores divided by the number of animals tested).
Challenge controls:
Yes
Positive control substance(s):
yes
Remarks:
2,4 Dinitrochlorobenzene

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin sensitization effect were observed.
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin sensitization effect was observed
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
Mortakity in one animal observed.Mortality was not compound related.
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
Motaliy was observed in one animal ,which was not related to compound.
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

No sensitization was observed.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
Skin sensitization study for Guanidine Nitrate was conducted in male Hartley guinea pig by Buehler test. Guanidine Nitrate does not have any sensitization effect on any guinea pigs.
Executive summary:

Skin sensitization study for Guanidine Nitrate was conducted in maleHartley guinea pig by Buehler test. Group of 10 male young adult Hartley guinea pigs were tested using the method of Buehler. The positive control material used in the test was 2,4 -Dinitrochlorobenzene (DNCB).After dermal induction with 10 % solution of test substance, no skin reaction was observed. Challenge treatment was performed with the same concentration of 10 %. None of the animals of the test group showed any skin sensitization effects. The sensitization effect was observed at 24 h and at 48 h. The result for skin sensitization effect was negative. Therefore Guanidine Nitrate (593-51-1) was considered to be non sensitizing in male adult Hartley guinea pigs.