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Registration Dossier
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EC number: 208-060-1 | CAS number: 506-93-4
Endpoint summary
Administrative data
Description of key information
In the key dermal sensitization study performed 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.
Supporting data:
Additional supporting data from the read-across substance guanidine chloride were included to demonstrate the similar toxicological profile of both substances. Data were used to substantiate the justification for read-across, outlined in IUCILD chapter 13 of technical dossier and chapter 1.1.2 Justification for Read-across (Analogue approach) of CSR.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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.
- 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 - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction: 10 % in isotonic saline
Challenge: 10 % in isotonic saline - 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
- 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.
- 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
- 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.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1984-05-09 to 1984-06-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Supporting information for read-across, structural analogue approach.
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: EPA TS-792 Dermal sensitisation. Health effects test guidelines, EPA, August 1982; EPA 560/6-82-001
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- 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: ca 4 weeks
- Weight at study initiation: 186 to 234 g on receipt
- Housing: individually
- Diet (e.g. ad libitum): Certified Purina Guinea Pig Chow Diet 5026, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13 d quarantine
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 to 24.4°C
- Humidity (%): 33 to 74%, with occasional spikes as high as 86%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 10% in saline
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 10% in saline
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
0.1, 1, 10, 100% to determine the highest non-irritating concentration
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: the test compound was applied for 6 h once a week for 3 weeks during the induction phase
- Test groups: 0.5 mL 10% test substance in saline
- Control group: 0.5 mL saline (negative control), 0.5 mL 0.1% Dinitrochlorobenzene
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after 3rd induction exposure
- Exposure period: 6 h
- Test groups: 0.5 mL 10% test substance in saline
- Control group: 0.5 mL 10% test substance in saline
- Site: previously treated site on the left side + new site on the right side
- Evaluation (hr after challenge): 24, 48 h - Challenge controls:
- To distinguish between reactions from primary irritation and sensitisation, negative controls were included which received only the challenge dose.
- Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- 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%. 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%
- 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%. 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:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- positive control
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: positive control. No with. + reactions: 9.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- positive control
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: positive control. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Guanidine hydrochloride was not sensitising in this Buehler test.
- Executive summary:
In a dermal sensitisation study performed according to the Health effects test guidelines, August 1982, EPA 560/6-82-001, which is similar to OECD guideline 406, with Guanidine hydrochloride (> 98% a.i.) in saline, 10 young male adult Hartley guinea pigs were tested using the method of Buehler. Dinitrochlorobenzene was used as positive control. The test substance was applied at a concentration of 10%.
The positive control induced the appropriate response. No sensitisation was observed for the test substance in any animals. For a test substance to be judged as positive, at least 15% of the treated animals have to be sensitised in this non-adjuvant test.
Although only 10 instead of 20 animals have been used, the study is considered reliable without restriction, as the results were clearly negative in the tested animals.
In this study, Guanidine hydrochloride is not a dermal sensitiser.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In the key dermal sensitization study performed 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.
Supporting data:
Additional supporting data from the read-across substance guanidine chloride were included to demonstrate the similar toxicological profile of both substances. Data were used to substantiate the justification for read-across, outlined in IUCILD chapter 13 of technical dossier and chapter 1.1.2 Justification for Read-across (Analogue approach) of CSR.
Migrated from Short description of key information:
The skin sensitization potential of Guanidine Nitrate has been assessed in a Buehler test and no effects have been observed.
Justification for classification or non-classification
According to CLP, EU GHS (Regulation (EC) No 1272/2008),
- Guanidine Nitrate is not classified for skin sensitization since the data available are conclusive and do not indicate any sensitizing properites.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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