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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented and scientifically acceptabl
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
SIDS Initial Assessment Report 2003 evaluated L, D, and racemic L/D mentols together and gives the rational for a menthol category as follows:
"Category Rationale: The menthols category is comprised of the isomers L-menthol, D-menthol, the racemate and menthol (unspecified
isomers). The menthols can be considered as a category because of their similarity in physico-chemical, toxicological,
ecotoxicological and environmental fate properties.
...
In summary, the available toxicity data indicate very similar toxicity profiles for all of the menthol isomers investigated."

The category justification is documented in a comprehensive 15 page annex to the SIDS Assessment report (Annex 1: Menthols Category JustificationCategory Justification). The annex is attached to the study record entry on the OECD SIDS evaluation as attached background material.
Reason / purpose:
read-across source
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25% in ethanol:DEP (vehicle)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
ethanol:DEP (vehicle)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25% in ethanol:DEP (vehicle)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% in ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
ethanol:DEP (vehicle)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
GHS criteria not met
Conclusions:
There is no evidence from the test results that HR 90/000102 (L-menthol) is a sensitiser in guinea pigs.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Principles of method if other than guideline:
The sensitisation potential of a test material, HR 90/000102 (= L-menthol), was investigated by means of the Buehler Test for sensitisation in guinea pigs.
Following dose ranging a concentration of 25% w/v in ethanol:DEP was selected for induction and challenge.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was conducted in 1991. At this time an OECD guideline for a LLNA was not available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Source and lot/batch No.of test material: HR 90/000102

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 25% wv in ethanol:diethylphthalate (1:1)
Concentration / amount:
25 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 25% wv in ethanol:diethylphthalate (1:1)
Concentration / amount:
25 %
No. of animals per dose:
test grup: 20 guine pigs
control group: 20 guinea pigs

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25% in ethanol:DEP (vehicle)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
ethanol:DEP (vehicle)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25% in ethanol:DEP (vehicle)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% in ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
ethanol:DEP (vehicle)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Induction

No irritation was noted in any of the test group animals in Weeks 1, 2 or 3 of induction.

No irritation was noted in the control group animals at any time during induction.

Challenge

No positive responses were noted in any of the animals in the test group or the control group after challenge

with HR 90/000102 at a concentration of 25% w/v in ethanol :DEP.

There were no reactions to challenge with the vehicle in the test or control groups.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The sensitisation potential of a test material, HR 90/000102 (L-menthol), was investigated by means of the Buehler Test for sensitisation in guinea pigs.

Following dose ranging a concentration of 25% w/v in ethanol:DEP was selected for induction and challenge.

At challenge, none of the test and control group animals treated with HR 90/000102 at a concentration of 25% w/v in ethanol:DEP showed a positive response.

There is no evidence from the test results that HR 90/000102 (L-menthol) is a sensitiser in guinea pigs.