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EC number: 205-488-0 | CAS number: 141-53-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study conducted prior to the loal lymph node assay becoming the assay of choice.
Test material
- Reference substance name:
- Potassium formate(1:2)
- EC Number:
- 243-934-6
- EC Name:
- Potassium formate(1:2)
- Cas Number:
- 20642-05-1
- Molecular formula:
- CH2O2.1/2K
- IUPAC Name:
- potassium formate(1:2)
- Details on test material:
- - Name of test material (as cited in study report): Formi-LHS
- Substance type: salt
- Physical state: white powder
- Analytical purity: no data
- Storage condition of test material: at room temperature in the dark
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Formi-LHS
- Substance type: salt
- Physical state: white powder
- Analytical purity: no data
- Storage condition of test material: at room temperature in the dark
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall Ltd; Burton on Trent
- Age at study initiation: approx. 6-11 weeks
- Weight at study initiation: body weight range of 428 to 773 g prior to dosing on Day 1
- Housing: in groups of up to five
- Diet: standard diet ad libitum
- Water: mains water ad libitum
- Acclimation period: 3 to 6 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-80
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: intradermal and topical
- Vehicle:
- water
- Concentration / amount:
- 1st application: Induction 0.5 % active substance intrdermal on Day 1
2nd application: Induction 15 % active substance topical on Day 8
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 3rd application: Challenge 5 or 10 % active substance occlusive epicutaneous
- No. of animals per dose:
- 10 control animals; 20 test animals
- Details on study design:
- RANGE FINDING TESTS: yes
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: exposures on days 1 and 8
- Test groups: control and treated groups
- Control group: received water
- Frequency of applications: two single applications
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: day 22
- Exposure period: 24 hours
- Test groups: control and treated groups
- Control group: received water
- Evaluation (hr after challenge): 24 and 48 hours after termination of challenge - Challenge controls:
- Yes
- Positive control substance(s):
- not required
- Remarks:
- hexyl cinnamic aldehyde (CAS number 101-86-0) and mercaptobenzothiazole (CAS number 149-30-4): regular positive testing (six monthly) in the laboratory
Results and discussion
- Positive control results:
- Annex 1 to the report contains results of experiments conducted by the laboratory using a positive control substance (2-mercaptobenzothiazole). 6/9 and 6/10 animals gave positive reactions.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Control - vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- control - vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Five animals showed desquamation
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Control - vaseline
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Three animals showed desquamation
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- Two animals showed desquamation
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Control - vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Ten animals showed desquamation
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Five animals showed desquamation
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Five animals showed desquamation
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Results of the main study:
No
clinical observations of ill health or toxicity were noted. All
animals gained weight over the course of the study.
Skin reactions after intradermal induction:
well defined erythema was noted at both anterior and posterior injection sites
for
both test and control animals. No erythema was noted at the middle
injection sites in test animals receiving 1.0% Formi-LHS
in purified water.
Skin reactions after topical application: slight erythema was apparent
in test animals following application of 15% M/m Formi-LHS
in Vaseline.
Skin reactions after challenge: slight erythema was noted at 24 h as
tabulated below. All skin reactions had resolved at 48 h.
Table
1: Skin reactions after challenge - Controls
Animal No. |
Score |
|||||
24 hours |
48 hours |
|||||
A |
P |
C |
A |
P |
C |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
1 |
0 |
0 |
0 |
0 |
0 Q |
5 |
0 |
0 |
0 |
0 |
0 |
0 Q |
6 |
0 |
0 |
0 |
0 |
0 |
0Q |
7 |
0 |
0 |
0 |
1 |
0 |
0 Q |
8 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
1 |
0 |
0 |
0 |
0 |
0 Q |
Key:
A: anterior site exposed to 10% Formi-LHS in Vaseline
P: posterior site exposed to 5% Formi-LHS in Vaseline
C: control site exposed to Vaseline
0: no erythema
1: slight erythema
Q: desquamation
Table 2: Skin reactions after challenge – Test group
Animal No. |
Score |
Results Positive [+] Inconclusive [±) Negative [-] |
|||||
24 hours |
48 hours |
||||||
A |
P |
C |
A |
P |
C |
||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
2 |
1 |
1 |
0 |
0 |
0 |
0 Q |
- |
3 |
1 |
1 |
1 |
0 |
0 |
0 |
- |
4 |
1 |
0 |
0 |
1 |
0 |
0 |
- |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
6 |
0 |
0 |
0 |
0 Q |
0 Q |
0 Q |
- |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
8 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
9 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
10 |
1 |
0 |
0 |
0 Q |
0 Q |
0 Q |
- |
11 |
1 Q |
1 Q |
0 Q |
0 Q |
0 Q |
0 Q |
- |
12 |
0 |
0 |
0 Q |
0 |
0 |
0 Q |
- |
13 |
1 Q |
1 Q |
1 Q |
0 |
0 |
0 Q |
- |
14 |
1 |
0 |
0 |
0 |
0 |
0 Q |
- |
15 |
0 |
0 |
0 |
0 Q |
0 Q |
0 Q |
- |
16 |
0 |
0 |
0 |
0 |
0 |
0 Q |
- |
17 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
18 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
19 |
1 Q |
0 |
0 |
0 Q |
0 Q |
0 Q |
- |
20 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
Key:
A: anterior site exposed to 10% Formi-LHS in Vaseline
P: posterior site exposed to 5% Formi-LHS in Vaseline
C: control site exposed to Vaseline
0: no erythema
1: slight erythema
Q: desquamation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Potassium diformate lacks a skin sensitising potential. As it forms formic acid and formate anion in aqueous solutions, these are also considered to be negative.
- Executive summary:
Potassium diformate (1:2) was not sensitizing in a Guinea pig maximization test (10 controls, 20 test animals) that was conducted according to OECD 406 and under GLP. The concentration of the test substance was 0.5 and 15% dissolved in purified water during induction and 10% at challenge; the test concentrations were selected following preliminary studies. No skin reactions were seen in the 20 test and 10 control animals at 24 or 48 hours after challenge. Potassium diformate, therefore, is not a skin sensitiser (Covance Laboratories, 1998).
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