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Description of key information

Skin sensitisation studies with cornmint oil (WoE, GPMT OECD 406): Sensitizing

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
11 May 1983 - 6 July 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information on test substance identity not reported. Results acceptable as basic data.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
other: Magnusson and Kligman GPMT
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing study, performed before LLNA was available as OECD guideline
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
no data
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Remarks:
and polyetylene glycol
Concentration / amount:
Injection induction: 0.25% test substance suspended in physiological saline
Application induction: 25% test substance mixed with polyethylene glycol
Application challenge: 5% test substance
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Remarks:
and polyetylene glycol
Concentration / amount:
Injection induction: 0.25% test substance suspended in physiological saline
Application induction: 25% test substance mixed with polyethylene glycol
Application 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.
Positive control substance(s):
no
Positive control results:
not applicable
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
1 animals showed moderate erythema, 4 animals showed faint erythema
Remarks on result:
other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: 1 animals showed moderate erythema, 4 animals showed faint erythema.
Reading:
other: Challenge 1
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
4 animals showed faint/moderate erythema, 1 animal showed very faint erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: Challenge 1. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 4 animals showed faint/moderate erythema, 1 animal showed very faint erythema.
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 animal showed very faint erythema
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: 1 animal showed very faint erythema.
Remarks:
treated negative control
Reading:
other: Challenge 1
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 animal showed very faint erythema
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: 1 animal showed very faint erythema.
Remarks:
treated negative control
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 animal showed very faint erythema
Remarks on result:
other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animal showed very faint 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 showed 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 showed very faint erythema.
Reading:
other: Challenge 2
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
1 animal showed moderate erythema, 4 animals showed faint erythema, 2 animals showed very faint erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: Challenge 2. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: 1 animal showed moderate erythema, 4 animals showed faint erythema, 2 animals showed very faint erythema.
Reading:
other: Challenge 2
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
5 animals showed faint erythema, 3 animals showed 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: 5.0. Total no. in groups: 10.0. Clinical observations: 5 animals showed faint erythema, 3 animals showed very faint erythema.
Reading:
other: Challenge 2
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reactions
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 reactions.
Remarks:
treated negative control
Reading:
other: Challenge 2
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reactions
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 reactions.
Remarks:
treated negative control
Reading:
other: Challenge 2
Hours after challenge:
24
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reactions
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: no reactions.
Reading:
other: Challenge 2
Hours after challenge:
48
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reactions
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: no reactions.
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:
1 animal showed moderate erythema, 3 animals showed faint erythema, 5 animals showed very faint 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: 1 animal showed moderate erythema, 3 animals showed faint erythema, 5 animals showed very faint erythema.
Reading:
other: Challenge 3
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
3 animals showed moderate erythema, 2 animals showed faint erythema, 1 animal showed very faint 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: 5.0. Total no. in groups: 10.0. Clinical observations: 3 animals showed moderate erythema, 2 animals showed faint erythema, 1 animal showed very faint 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 animals showed small spots of 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 animals showed small spots of erythema.
Reading:
other: Challenge 3
Hours after challenge:
48
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reactions
Remarks on result:
other: Reading: other: Challenge 3. . Hours after challenge: 48.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reactions.
Group:
positive control
Remarks on result:
not measured/tested

no data

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Cornmint oil (Peppermint Brazilian) had 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 Brazilian) 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 Brazlilian, 4 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 I of 1272/2008/EC and Annex VI of EU Directive 67/548/EEC). Therefore, according to the results of this test, the substance is a sensitiser.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Identification data on test substance not reported. Results are acceptable as basic data.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
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
Justification for non-LLNA method:
Existing study, performed before LLNA was available as OECD guideline
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
no data
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
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
Positive control results:
not applicable
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:
negative control
Dose level:
treated negative control
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:
negative control
Dose level:
treated negative control
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:
negative control
Dose level:
treated negative control
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:
negative control
Dose level:
treated negative control
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.
Group:
positive control
Remarks on result:
not measured/tested

no data

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 I of 1272/2008/EC and Annex VI of EU Directive 67/548/EEC). Therefore, according to the results of this test, the substance is not a sensitiser.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
11 May 1983 - 14 July 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information on test substance identity not reported. Results acceptable as basic data.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
other: Magnusson and Kligman GPMT
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing study, performed before LLNA was available as OECD guideline
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
no data
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Remarks:
and polyethylene glycol
Concentration / amount:
Injection induction: test substance concentration of 0.25% suspended in physiological saline
Application induction: test substance concentration of 25% mixed with polyethylene glycol
Application challenge: test substance concentration of 5%
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Remarks:
and polyethylene glycol
Concentration / amount:
Injection induction: test substance concentration of 0.25% suspended in physiological saline
Application induction: test substance concentration of 25% mixed with polyethylene glycol
Application challenge: test substance concentration of 5%
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.
Positive control substance(s):
no
Positive control results:
not applicable
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
4
Total no. in group:
9
Clinical observations:
2 animals showed moderate erythema, 2 animals showed faint erythema, 2 animals showed very faint erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 4.0. Total no. in groups: 9.0. Clinical observations: 2 animals showed moderate erythema, 2 animals showed faint erythema, 2 animals showed very faint erythema.
Reading:
other: Challenge 1
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
3
Total no. in group:
9
Clinical observations:
1 animal showed moderate erythema, 2 animals showed faint erythema, 3 animals showed very faint erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: Challenge 1. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 3.0. Total no. in groups: 9.0. Clinical observations: 1 animal showed moderate erythema, 2 animals showed faint erythema, 3 animals showed very faint erythema.
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
negative control
Dose level:
treated negative control
No. with + reactions:
0
Total no. in group:
3
Clinical observations:
no reactions
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: 3.0. Clinical observations: no reactions.
Reading:
other: Challenge 1
Hours after challenge:
48
Group:
negative control
Dose level:
treated negative control
No. with + reactions:
0
Total no. in group:
3
Clinical observations:
no reactions
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: 3.0. Clinical observations: no reactions.
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reactions
Remarks on result:
other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reactions.
Reading:
other: Challenge 1
Hours after challenge:
48
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
2 animals showed 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: 2 animals showed very faint erythema.
Reading:
other: challenge 2
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
1 animal showed faint erythema, 3 animals showed 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: 1.0. Total no. in groups: 9.0. Clinical observations: 1 animal showed faint erythema, 3 animals showed 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:
9
Clinical observations:
4 animals showed 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: 9.0. Clinical observations: 4 animals showed very faint erythema.
Reading:
other: Challenge 2
Hours after challenge:
24
Group:
negative control
Dose level:
treated negative control
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 animal showed small spots of erythema
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: 1 animal showed small spots of erythema.
Reading:
other: Challenge 2
Hours after challenge:
48
Group:
negative control
Dose level:
treated negative control
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 animal showed small spots of erythema
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: 1 animal showed small spots of erythema.
Reading:
other: Challenge 2
Hours after challenge:
24
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reactions
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: no reactions.
Reading:
other: Challenge 2
Hours after challenge:
48
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reactions
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: no reactions.
Reading:
other: Challenge 3
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
4
Total no. in group:
9
Clinical observations:
1 animal showed marked erythema and necrosis, 3 animals showed faint erythema, 2 animals showed very faint erythema, 1 animal showed small spots of 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: 9.0. Clinical observations: 1 animal showed marked erythema and necrosis, 3 animals showed faint erythema, 2 animals showed very faint erythema, 1 animal showed small spots of erythema.
Reading:
other: Challenge 3
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
2
Total no. in group:
9
Clinical observations:
1 animal showed marked erythema and necrosis, 1 animal showed moderate erythema, 3 animals showed very faint 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: 2.0. Total no. in groups: 9.0. Clinical observations: 1 animal showed marked erythema and necrosis, 1 animal showed moderate erythema, 3 animals showed very faint 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:
no reactions
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: no reactions.
Reading:
other: Challenge 3
Hours after challenge:
48
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
no reactions
Remarks on result:
other: Reading: other: Challenge 3. . Hours after challenge: 48.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no reactions.
Group:
positive control
Remarks on result:
not measured/tested

no data

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Cornmint oil (Peppermint Brazilian) had 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 Brazilian) 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 Brazlilian, 3 out of 9 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 I of 1272/2008/EC and Annex VI of EU Directive 67/548/EEC). Therefore, according to the restults of this test, the substance is a sensitiser.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
11 May 1983 - 22 July 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Identification data on test substance not reported. Results are acceptable as basic data.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
other: Magnusson and kligman guinea pig maximisation test (GPMT)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing study, performed before LLNA was available as OECD guideline
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
no data
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Remarks:
and polyethylene glycol
Concentration / amount:
Injection induction solution: concentration of test substance 0.25% ,suspended in physiological saline.
Application indution solution: concentration of test substance 25%, mixed with polyethylene glycol.
Challenge: concentration of test substance: 5%
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Remarks:
and polyethylene glycol
Concentration / amount:
Injection induction solution: concentration of test substance 0.25% ,suspended in physiological saline.
Application indution solution: concentration of test substance 25%, mixed with polyethylene glycol.
Challenge: concentration of test substance: 5%
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.
Positive control substance(s):
no
Positive control results:
not applicable
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
3 animals show faint erythema, 2 animals show moderate erythema
Remarks on result:
other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: 3 animals show faint erythema, 2 animals show moderate erythema.
Reading:
other: Challenge 1
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
2 animals show faint erythema, 2 animals show moderate erythema, 1 animal shows very faint erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: Challenge 1. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 2 animals show faint erythema, 2 animals show moderate erythema, 1 animal shows very faint erythema.
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
negative control
Dose level:
treated negative control
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: 24.0. Group: other: treated negative controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animal shows very faint erythema.
Reading:
other: Challenge 1
Hours after challenge:
48
Group:
negative control
Dose level:
treated negative control
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: treated negative controls. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: 1 animal shows very faint erythema.
Reading:
other: Challenge 1
Hours after challenge:
24
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: Challenge 1. . Hours after challenge: 24.0. Group: other: untreated negative controls. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: Challenge 1
Hours after challenge:
48
Group:
other: untreated negative controls
No. with + reactions:
0
Total no. in group:
4
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.
Reading:
other: Challenge 2
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
2 animals show moderate erythema, 1 animal shows faint erythema, 3 animals show very faint erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: Challenge 2. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: 2 animals show moderate erythema, 1 animal shows faint erythema, 3 animals show very faint erythema.
Reading:
other: Challenge 2
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
2 animals show faint erythema, 4 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: 2.0. Total no. in groups: 10.0. Clinical observations: 2 animals show faint erythema, 4 animals show very faint erythema.
Reading:
other: Challenge 2
Hours after challenge:
24
Group:
negative control
Dose level:
treated negative control
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 animal shows small spots of erythema
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: 1 animal shows small spots of erythema.
Reading:
other: Challenge 2
Hours after challenge:
48
Group:
negative control
Dose level:
treated negative control
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
1 animal shows very faint erythema
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: 1 animal shows very faint erythema.
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 animal shows very faint 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 animal shows very faint 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 animal shows small spots pf erythema, 1 animal shows very faint erythema
Remarks on result:
other: see Remark
Remarks:
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 animal shows small spots pf erythema, 1 animal shows very faint erythema.
Reading:
other: Challenge 3
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, 4 animals show very faint erythema
Remarks on result:
other: Reading: other: Challenge 3. . 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, 4 animals show very faint erythema.
Reading:
other: Challenge 3
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
1 animal shows faint erythema, 2 animals show very faint erythema
Remarks on result:
other: Reading: other: Challenge 3. . 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 faint erythema, 2 animals show very faint 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 animal shows small spots of erythema, 1 animal shows very faint erythema
Remarks on result:
other: see Remark
Remarks:
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 animal shows small spots of erythema, 1 animal shows very faint erythema.
Reading:
other: Challenge 3
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 3. . 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.
Group:
positive control
Remarks on result:
not measured/tested

no data

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Cornmint oil (Peppermint Chinese) had 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 Chinese) 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 Chinese, 4 out of 10 test 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 I of 1272/2008/EC and Annex VI of EU Directive 67/548/EEC). Therefore, according to the results of this study, the substance is a sensitiser.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Several studies on the skin sensitising potential of Cornmint oil were available for the dossier. Because of the comparable reliability between the studies and the differing outcomes, a Weight of Evidence approach was used to describe the endpoint of skin sensitisation.

Four guinea pig maximisation tests were available with different forms of cornmint oil, one using Peppermint Arvensis (65% Peppermint Brazilian and 35% Peppermint Chinese), one using Peppermint Chinese, and two using Peppermint Brazilian. In all tests three challenges with the test substance were performed. The first two challenges with Peppermint Arvensis indicated no skin sensitisation, only after three challenges sensitisation was indicated. The first challenge with Peppermint Chinese indicated skin sensitisation. However, the second and third challenge did not indicate skin sensitisation. In both studies conducted with Peppermint Brazilian, the first and third challenge indicated skin sensitisation.

Additionally tot the guinea pig maximisation tests, a human repeated occluded patch test was available which indicated allergic contact sensitisation in 2 out of 22 male subjects.

Based on the above information, it was concluded that Cornmint oil is a substance that possesses the ability to induce skin sensitisation. Three of the four animal studies indicated sensitisation and the human study indicated skin sensitisation in two subjects.

Migrated from Short description of key information:

Skin sensitisation (Weight of Evidence):

- GPMT (5% Peppermint Arvensis): not sensitising (method similar to OECD 406)

- GPMT (5% Peppermint Chinese): sensitising (method similar to OECD 406)

- GPMT (5% Peppermint Brazilian): sensitising (method similar to OECD 406)

- GPMT (5% Peppermint Brazilian): sensitising (method similar to OECD 406)

- Maximization test (humans): sensitising

Justification for selection of skin sensitisation endpoint:

No selection is made as a Weight of Evidence approach was followed which is described below.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, Cornmint oil needs to be classified for skin sensitisation when taking into account the criteria outlined in Annex VI of 1272/2008/EC and Annex I of 67/548/EEC.