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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across from cornmint oil. Identification data on test substance not reported. Results are acceptable as basic data.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Magnusson and Kligman guinea pig maximisation test (GPMT)
Deviations:
no
Principles of method if other than guideline:
not relevant
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Cornmint oil
IUPAC Name:
Cornmint oil
Details on test material:
- Name of test material (as cited in study report): Peppermint Arvensis
- Composition of test material, percentage of components: Confidential information

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal injection induction: 0.25 % test substance (suspended in physiological saline)
Topical application induction: 25% test substance (mixed with polyethylene glycol)
Challenge: 5% test substance
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
Intradermal injection induction: 0.25 % test substance (suspended in physiological saline)
Topical application induction: 25% test substance (mixed with polyethylene glycol)
Challenge: 5% test substance
No. of animals per dose:
10
Details on study design:
no data
Challenge controls:
During the first and second challnge, four control animals are selected as treated controls. The receive four intradermal injections of 50% FCA in the test solvent followed seven days later by a 48 hour occluded patch of the test solvent over the injection sites. The four guinea pigs are challenged with the test substance in exactly the same way as the test animals at both the first and second challenge.
At every challenge in the test 4 previously untreated animals are treated exactly the same way as the test animals.
Positive control substance(s):
no

Study design: in vivo (LLNA)

Concentration:
not applicable
No. of animals per dose:
not applicable
Details on study design:
not applicable
Statistics:
not applicable

Results and discussion

Positive control results:
not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
1 animal shows moderate erythema, 2 animals show very faint erythema
Remarks on result:
other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1 animal shows moderate erythema, 2 animals show very faint erythema.
Reading:
other: Challenge 1
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
1 animal shows moderate erythema, 1 animal shows very faint erythema
Remarks on result:
other: Reading: other: Challenge 1. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1 animal shows moderate erythema, 1 animal shows very faint erythema.
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
other: treated negative controls
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reaction
Remarks on result:
other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: other: treated negative controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reaction.
Reading:
other: Challenge 1
Hours after challenge:
48
Group:
other: treated negative controls
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reaction
Remarks on result:
other: Reading: other: Challenge 1. . Hours after challenge: 48.0. Group: other: treated negative controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reaction.
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
other: untreated negative control
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 female showed small spots of erythema
Remarks on result:
other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: other: untreated negative control. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 female showed small spots of erythema.
Reading:
other: Challenge 1
Hours after challenge:
48
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 animal shows very faint erythema
Remarks on result:
other: Reading: other: Challenge 1. . Hours after challenge: 48.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animal shows very faint erythema.
Reading:
other: Challenge 2
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
3 animals show very faint erythema
Remarks on result:
other: Reading: other: Challenge 2. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 3 animals show very faint erythema.
Reading:
other: Challenge 2
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
3 animals show very faint erythema
Remarks on result:
other: Reading: other: Challenge 2. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 3 animals show very faint erythema.
Reading:
other: Challenge 2
Hours after challenge:
24
Group:
other: treated negative controls
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reaction
Remarks on result:
other: Reading: other: Challenge 2. . Hours after challenge: 24.0. Group: other: treated negative controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reaction.
Reading:
other: Challenge 2
Hours after challenge:
48
Group:
other: treated negative controls
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reaction
Remarks on result:
other: Reading: other: Challenge 2. . Hours after challenge: 48.0. Group: other: treated negative controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reaction.
Reading:
other: Challenge 2
Hours after challenge:
24
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 female shows small spots of erythema
Remarks on result:
other: Reading: other: Challenge 2. . Hours after challenge: 24.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 female shows small spots of erythema.
Reading:
other: Challenge 2
Hours after challenge:
48
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 female shows small spots of erythema
Remarks on result:
other: Reading: other: Challenge 2. . Hours after challenge: 48.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 female shows small spots of erythema.
Reading:
other: Challenge 3
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
4 animals show very faint erythema, 2 animals show faint erythema, and 2 animals show moderate erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: Challenge 3. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 4 animals show very faint erythema, 2 animals show faint erythema, and 2 animals show moderate erythema.
Reading:
other: Challenge 3
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
1 animal shows very faint erythema, 1 animal shows faint erythema, and 2 animals show moderate erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: Challenge 3. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: 1 animal shows very faint erythema, 1 animal shows faint erythema, and 2 animals show moderate erythema.
Reading:
other: Challenge 3
Hours after challenge:
24
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 male shows very faint erythema
Remarks on result:
other: Reading: other: Challenge 3. . Hours after challenge: 24.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 male shows very faint erythema.
Reading:
other: Challenge 3
Hours after challenge:
48
Group:
other: untreated negative control
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
2 males show very faint erythema
Remarks on result:
other: Reading: other: Challenge 3. . Hours after challenge: 48.0. Group: other: untreated negative control. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 2 males show very faint erythema.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: not applicable

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Cornmint oil (Peppermint Arvensis) did not have sensitising properties in the GPMT test, under the conditions of this test.
Executive summary:

In a GPMT-test, the sensitising properties of Cornmint oil were investigated. Guinea pigs were induced by intradermal injections of both test substance (Peppermint Arvensis) and FCA. Seven days later the induction was boosted by an occluded patch placed over the injection site. 14 days later the animals were challenged by occluded patch: further challenges were made at weekly intervals as required.

After 1 challenge with 5% Peppermint Arvensis, 1 out of 10 animals showed sensitisation. In this study an adjuvant is used for induction of sensitization. At least 30% of the animals have to be considered positive to classify the substance as a (mild/moderate) skin sensitizer. (Annex VI of EU Directive 67/548/EEC). Therefore, according to the restults of this test, the substance is not a sensitiser.