Registration Dossier
Registration Dossier
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EC number: 203-481-7 | CAS number: 107-31-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: Experimental study with formic acid, a metabolite of methyl formate.
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Japan MAFF TG of 12 Nosan No. 8147
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- read-across data
Test material
- Reference substance name:
- Formic acid
- EC Number:
- 200-579-1
- EC Name:
- Formic acid
- Cas Number:
- 64-18-6
- Molecular formula:
- CH2O2
- IUPAC Name:
- formic acid
- Details on test material:
- - Name of test material (as cited in study report): formic acid
- Analytical purity: 85.3 g formic acid/100 g total aqueous formulation
- Impurities (identity and concentrations): water, 14.7%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc: DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, FRG
- Age at study initiation: about 6 weeks
- Weight at study initiation: 320- 370 g
- Housing: in groups of 5 per cage. Stainless steel wire mesh cage with plastic-coated grating.
- Diet: standard diet and tap water ad libitum.
- Water: standard diet and tap water ad libitum.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 7,5 % occlusive epicutaneous
Challenge: 2 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 7,5 % occlusive epicutaneous
Challenge: 2 % occlusive epicutaneous
- No. of animals per dose:
- 20 control and 20 test animals in the main study
- Details on study design:
RANGE FINDING TESTS:
- No. of animals: 6 animals were used to determine the appropriate doses of the main test.
- No. of exposures: 1
- Exposure period: 6 hours
- Concentrations: 1% and 5% occlusive epicutaneous
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours each
- Test groups: 0.5 mL of the test substance solution
- Control group: distilled water
- Site: intact flank
- Frequency of applications: one application per week ; days 0, 7 and 14 on the same application area
- Duration: 6 hours each
- Concentrations: 7,5 % occlusive epicutaneous
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the 3rd induction.
- Exposure period: 6 hours
- Test groups: 0.5 mL of the test substance solution
- Control group: 0.5 mL of the test substance solution (control group 2 remained untreated)
- Site: intact flank
- Concentrations: 2 % occlusive epicutaneous
- Evaluation (hr after challenge): 48
- Challenge controls:
- Yes. Control group: 0.5 mL of the test substance solution (control group 2 remained untreated)
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde, 85%, technical grade
Results and discussion
- Positive control results:
- Alpha-hexylcinnamaldehyde is routinely used in this laboratory
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5%
- 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: 5%. No with. + reactions: 9.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 5%. No with. + reactions: 9.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Pretest
Minimum irritant concentration: 5%.
Maximum non-irritant concentration: 2%.
Main test
None of the 20 test group animals or the 10 control group
animals showed any skin findings at 24 or 48 h after the challenge.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
Conclusion:
Formic acid had no sensitizing effect on the skin of the Guinea pig in a valid Buehler test.
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