Registration Dossier
Registration Dossier
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EC number: 205-488-0 | CAS number: 141-53-7
Endpoint summary
Administrative data
Description of key information
A skin sensitisation study is available for the read-across substance, potassium formate.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- 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.
- 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 - 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 - 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 - 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
- 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.
- 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
- 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).
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to the detailed justification in Section 13 - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- 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.
- 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 - 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 - 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
- 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.
- 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
- 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).
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
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
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Read across can be made from Potassium diformate (1:2) which decomposes into potassium, formic acid, and formate anion in aqueous solution. Potassium diformate 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).
The study is considered to be full valid and suitable for assessment. This result can be extrapolated to sodium formate.
Migrated from Short description of key information:
Negative results from a related formate salt, potassium diformate, in the Guinea pig maximisation test suggest that formic acid and formate anion lack a skin sensitising potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
A Maximisation study with the read-across substance potassium diformate reports a negative result. Sodium formate does not therefore require classification as a skin sensitiser under the CLP Regulation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
