Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed under GLP conditions according to OECD guidlines
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding Centre ApS, DK-4623 Lille Skensved
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 273 to 348 g
- Housing: Opaque PPL (Type IV) cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): vitamin C enriched water on tap ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 6 times/h
- Photoperiod (hrs dark / hrs light): 12h dark / 12 hours light
Route:
intradermal and epicutaneous
Vehicle:
other: For intradermal induction groundnut oil was used as vehicle and for dermal induction Ethanol/Diethylphthalate 1:1 was used as vehicle
Concentration / amount:
For intradermal induction a concentrations of 5 % (w/w) was chosen.
For the dermal induction a concentration of 50 % (w/w) was chosen.
For the occlusive epicutaneous challenge on the back a concentration of 25 % (w/w) was chosen.
Route:
epicutaneous, occlusive
Vehicle:
other: For intradermal induction groundnut oil was used as vehicle and for dermal induction Ethanol/Diethylphthalate 1:1 was used as vehicle
Concentration / amount:
For intradermal induction a concentrations of 5 % (w/w) was chosen.
For the dermal induction a concentration of 50 % (w/w) was chosen.
For the occlusive epicutaneous challenge on the back a concentration of 25 % (w/w) was chosen.
No. of animals per dose:
20 animals were used in the test group
Details on study design:
RANGE FINDING TESTS:
Investigation tests for topical irritancy were performed including each one topical application of a 25 % (w/w) and 50 % (w/w) solution on each back of two animals and each two topical applications of 5 % (w/w), 10 % (w/w), 25 % (w/w) and 50 % (w/w) solutons on the flank of two animals. Also an investigation test for intradermal irritancy was performed including each 10 injections of the test material at concentrations of 1.25 % (w/w), 2.5 % (w/w), 5 % (w/w) and 10 % (w/w) into the scapular region each of two animals.
Based on these investigations a dose levels of 5 % (w/w) for the intradermal induction, a dose level of 50 % (w/w) for the dermal induction and a dose level of 25 % (w/w) for the challenge application was chosen.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: one intradermal injection followed by one topical exposure
- Exposure period: 48 hours (topically)
- Test groups: 1 test group with 20 animals
- Control group: 1 control group with 20 animals
- Site: right and left flank (topically)
- Frequency of applications: three pairs of injections simutaneously, one topically application
- Duration:
- Concentrations: 5 % (w/w) intradermal and 50% (w/w) topical

B. CHALLENGE EXPOSURE
- No. of exposures:one topical exposure on both flanks
- Day(s) of challenge: 1 day
- Exposure period: 24 hours
- Site: left and right flank
- Concentrations: 25 % (w/w)
- Evaluation (hr after challenge): 24, 48 and 72 hours
Challenge controls:
An induction control group was included with was treated by intradermal injection with a mixture of Freund's complete adjuvant in water (1:1), the vehicle, and a mixture of Freund's complete adjuvant and the vehicle (1:1). Six days after the injections the same skin was treated with 10 % sodium lauryl sulphate in petrolatum. 24 hours later 0.4 mL ethanol 96 % : DEP (1:1) was spread over a patch which was then applied to the skin and fixed with impermeable adhesive tape. The dressing was left in place for 48 hours. The guinea pigs were challenged topically three weeks after the intradermal induction. The vehicle was ethanol 96% and diethyl phthalate (1:1).
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 % (w/w)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
not reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 % (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not reported.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 % (w/w)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
not reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 % (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not reported.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25 % (w/w)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
not reported
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 % (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not reported.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %(w/w)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
not reported
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %(w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not reported.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 % (w/w)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
not reported
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not reported.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25 % (w/w)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
not reported
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 % (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not reported.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the test Menthyl lactate did not provoke a delayed contact hypersensitivity in guinea pigs. The substance is considered as non-sensitising to the skin.
Executive summary:

The allergenic potential of Menthyl lactate was investigated according to one of the methods recommended in the OECD Guidelines No. 406, "Skin Sensitization", 1981. The delayed contact hypersensitivity test used was the Guinea Pig Maximization Test described by B. Magnusson and A. M. Kligman (1970), and by Klecak (1977). Suitable test concentrations were determined in pre-tests on intradermal and topical irritancy. Intradermal induction was done by injecting 5 % substance in ground nut oil into dorsal skin in the scapular region. Six days later the same skin area was treated with 10 % sodium lauryl sulphate in petrolatum and 24 hours later a patch treated with 0.4 mL of 50 % test substance dissolved in ethanol 96 % : diethyl phthalate (1:1) was placed on the area and fixed with impermeable adhesive tape. This dressing was left in place for 48 hours. The guinea pigs were challenged topically three weeks after intradermal induction. About 0.1 mL of 25 % test substance in ethanol 96 % : diethyl phthalate (1:1) was applied with patches to the left flanks of the animals and the vehicle alone was applied to the right flanks. The patches were fixed and removed after 24 hours. Reading of the challenge reactions was done 24, 48 and 72 hours after removal of the patches.

Under the experimental conditions described in the test report the substance Menthyl lactate did not produce any evidence of delayed contact hypersensitivity in guinea pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The study was performed to assess the skin sensitisation potential of Menthyl lactate in the Dunkin-Hartley guinea pig according to maximisation test. This method was designed to be compatible with OECD TG 406. The effects observed in the control and test item animals are considered not sensitising. Therefore Menthyl lactate is deemed to be not sensitiser.


Migrated from Short description of key information:
The test item was considered to be a non-sensitiser under the conditions of the test.

Justification for selection of skin sensitisation endpoint:
The key study was performed under GLP and in accordance with OECD TG 406.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
not required

Justification for classification or non-classification

Since no sensitising effects were observed in the key study, Menthyl lactate does not need to be classified for sensitisation according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) or according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.