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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:
key study
Study period:
1984-07-03 to 1984-08-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988
Reference Type:
publication
Title:
Ocular and Dermal Toxicity of Guanidine Nitrate
Author:
Korte DW et al
Year:
1993
Bibliographic source:
International Journal of Toxicology, Vol. 12, No. 6, 592-593

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Health effects test guidelines, August 1982, EPA 560/6-82-001
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
; only 10 animals were used instead of 20, but as in all 10 animals clear negative results were obtained, this deviation is not considered relevant
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The Study was conducted before the the Guideline for the LLNA-Test (OECD 429 and 442A/B) has been adopted.

Test material

Constituent 1
Chemical structure
Reference substance name:
Guanidinium nitrate
EC Number:
208-060-1
EC Name:
Guanidinium nitrate
Cas Number:
506-93-4
Molecular formula:
CH6N4O3
IUPAC Name:
amino(imino)methanaminium nitrate
impurity 1
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
water
impurity 2
Chemical structure
Reference substance name:
Ammonium nitrate
EC Number:
229-347-8
EC Name:
Ammonium nitrate
Cas Number:
6484-52-2
Molecular formula:
H3N.HNO3
IUPAC Name:
Ammonium nitrate
impurity 3
Chemical structure
Reference substance name:
4,6-diamino-1,3,5-triazin-2(1H)-one
EC Number:
211-455-1
EC Name:
4,6-diamino-1,3,5-triazin-2(1H)-one
Cas Number:
645-92-1
Molecular formula:
C3H5N5O
IUPAC Name:
4,6-diamino-1,3,5-triazin-2(1H)-one
impurity 4
Chemical structure
Reference substance name:
(4,6-Diamino-1,3,5-triazine-2-yl)guanidine
Cas Number:
4405-08-7
Molecular formula:
C4H8N8
IUPAC Name:
(4,6-Diamino-1,3,5-triazine-2-yl)guanidine
impurity 5
Chemical structure
Reference substance name:
Melamine
EC Number:
203-615-4
EC Name:
Melamine
Cas Number:
108-78-1
Molecular formula:
C3H6N6
IUPAC Name:
1,3,5-triazine-2,4,6-triamine
impurity 6
Chemical structure
Reference substance name:
Cyanoguanidine
EC Number:
207-312-8
EC Name:
Cyanoguanidine
Cas Number:
461-58-5
Molecular formula:
C2H4N4
IUPAC Name:
1-cyanoguanidine
Test material form:
solid: crystalline

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

IN-LIFE DATES: From: 1984-07-03 To: 1984-08-27

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Induction: 10 % in isotonic saline
Challenge: 10 % in isotonic saline
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Induction: 10 % in isotonic saline
Challenge: 10 % in isotonic saline
No. of animals per dose:
4 - pilot dosing
10 main test treatment
10 main test positive control
10 main test negative control
Details on study design:
PILOT STUDY FOR DOSE RANGE FINDING
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).



Positive control substance(s):
yes
Remarks:
2,4 Dinitrochlorobenzene

Results and discussion

Positive control results:
DNCB produced a marked response after the first induction dose, i.e. after the second and third induction and after challenge. Among the positive control animals, the incidence of skin reactions was 9/9 after 24h and 7/9 after 48h. 1/10 animals was lost due to non-compound-related death. The severity of skin reactions was 1.33 after 24h and 1.11 after 48h. Only one response, a 0.5 borderline score, was observed 24h after challenge in one negative control animal. Conclusion: In this study, 24h after challenge treatment performed with 0.1% DNCB, 100% of the animals of the test group were observed with skin reactions.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 % in isotonic saline
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % in isotonic saline. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 % in isotonic saline
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % in isotonic saline. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 % in isotonic saline
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
one non-compound-related death
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 % in isotonic saline. No with. + reactions: 1.0. Total no. in groups: 9.0. Clinical observations: one non-compound-related death .
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 % in isotonic saline
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
one non-compound-related death
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 % in isotonic saline. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: one non-compound-related death .
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 %
No. with + reactions:
9
Total no. in group:
9
Clinical observations:
Skin reaction
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1 %
No. with + reactions:
7
Total no. in group:
9
Clinical observations:
Skin reaction
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

PILOT STUDY AND DOSE RANGE FINDING

Concentration for induction and challenge:10%

SKIN EFFECTS IN INDUCTION

No skin reaction was observed after the first, second and third induction in the control and test animals treated with the test item at 10 % in isotonic saline.

SKIN EFFECTS IN CHALLENGE

A very slight skin reaction was observed in 1/9 negative control animals 24 h after challenge, no skin reaction observed in the test animals: Treatment at challenge was performed with the test item at 10 % in isotonic saline.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study the test substance Guanidine Nitrate is not a dermal sensitiser.
Executive summary:

In a dermal sensitization study according to the Health effects test guidelines, August 1982, EPA 560/6-82-001 with Guanidine Nitrate (a.i. 99.99%) diluted in isotonic saline, male young adult Hartley guinea pigs (10 per group) 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 effects, whereas one animal of the control group showed a very slight skin reaction.

 

The sensitization rate at 24 h and at 48 h was 0 %.

The test article is considered to be a non-sensitizer in this study.