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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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.
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 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

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 Brazilian
- Substance type: processed essential oil

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:
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
Challengeopen allclose all
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

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:
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

Any other information on results incl. tables

no data

Applicant's summary and conclusion

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.