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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to the OECD guideline 406 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
EC Number:
604-569-1
Cas Number:
147126-62-3
Molecular formula:
C14H24O4S
IUPAC Name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
Test material form:
other: White to light pink/yellow solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: HA(BR)
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males >300 g
- Housing: 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18- 26°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: moistened with Water for Injection
Concentration / amount:
Induction: 25%, 50% , 75% and 100%
Challenge: 100%
The maximum non-irritant concentration was determined in a pre-test.
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: moistened with Water for Injection
Concentration / amount:
Induction: 25%, 50% , 75% and 100%
Challenge: 100%
The maximum non-irritant concentration was determined in a pre-test.
No. of animals per dose:
Negative control: 10 male guinea pigs
Positive control: 5 male guinea pigs
Test item group: 20 male guinea pigs
Challenge controls:
15 days after the last induction application, the right flanks of all test and control animals were cleared of hair (closely clipped).
The test item was applied in the same marmer as during the induction phase, for a 6-hour exposure period on study Day 28, to the posterior right flanks of each test and negative control animal.
Positive control substance(s):
yes
Remarks:
DNCB

Results and discussion

Positive control results:
100% of the animals in the positive control group showed scores of 1.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 % DNCB
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 % DNCB. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1 % DNCB
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 % DNCB. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: None.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An evaluation of skin reaction was carried out and recorded at 24 and 48 hours after completion of each application. None of the guinea pigs treated with the test item had any signs of local skin irritation after the challenge period. Based on these findings, the test item was found to be non-sensitizing in a Buehler Skin Sensitization Study in guinea pigs.
Executive summary:

Based on the results of this study the test item is considered to be non-sensitzing to the skin of guinea pigs.