Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-05-09 to 1984-06-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
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:
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
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
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.
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.
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.
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.
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:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
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 conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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.

In this study, Guanidine hydrochloride is not a dermal sensitiser.

Supporting data

Additional supporting data from the read-across substance guanidine nitrate were included to demonstrate the similar toxicological profile of both substances. Data were used to substantiate the justification for read-across, outlined in IUCLID 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 sensitisation potential of Guanidine hydrochloride has been assessed in a Buehler test and no effects have been observed.

Justification for selection of skin sensitisation endpoint:
Only one key study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to CLP, EU GHS (Regulation (EC) No 1272/2008), Guanidine hydrochloride is not classified for skin sensitisation since the data available are conclusive and do not indicate any sensitising properties.