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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: read across from metabolite
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:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
other: Japan MAFF TG of 12 Nosan No. 8147
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
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%

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 group
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 group
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.