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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is non-GLP and similar to OECD TG 426. It well documented, meets generally accepted scientific principles and is therefore acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
Method: Popliteal lymph node assay (PLNA)
Principles of method if other than guideline:
Method: Popliteal lymph node assay (PLNA)
GLP compliance:
not specified
Type of study:
other: Popliteal lymph node assay (PLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
p-menth-1-en-8-ol
EC Number:
202-680-6
EC Name:
p-menth-1-en-8-ol
Cas Number:
98-55-5
Molecular formula:
C10H18O
IUPAC Name:
2-(4-methylcyclohex-3-en-1-yl)propan-2-ol
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): alpha-terpineol
- CAS number: 98-55-5
- Source: Sigma Chemical (St. Louis MO, USA)

In vivo test system

Test animals

Species:
other: rat
Strain:
other: Wistar
Sex:
female

Results and discussion

Any other information on results incl. tables

Table 1: Primary PLNA responses

 

 Criteria

Negative controls

Vehicle

Chlorpromazine

 

 Terpineol 

 Barbital 

DMSO

 Saline

0.5 mg/paw

2.5 mg/paw

5.0 mg/paw

 N 

 10 

 8 

 47 

 50 

 4 

 6 

 11 

 WI 

 1.32 ± 0.71 

 1.06 ± 0.36 

 1.48 ± 0.65 

 1.12 ± 0.90 

 1.30 ± 0.35 

 2.06 ± 0.81* 

 3.22 ± 1.13* 

 CI 

 2.00 ± 3.32 

 1.34 ± 0.92 

 2.95 ± 3.68 

 2.04 ± 2.03 

 1.26 ± 0.81 

 8.49 ± 8.91* 

 8.28 ± 8.19* 

 IPR, no. (%) 

 2 (20) 

 0 (0) 

 5 (10.6) 

 3 (6) 

 0.0 

 50.0 

 63.6* 

* indicates that the value differs from that of the lowest dose group (0.5 mg/paw)

- Injected doses were 5 mg/paw (monoterpenes and barbital) or 50 µL /paw (vehicles).

- Values are means ± SD;

- Weight (WI) and Cellularity (CI) indices: values for the draining popliteal lymph node of the treated (right paw) side divided by that of the control (left paw) side.

- IPR, number (%) of rats within the group with WI 2 and CI 5.

- Substances were classified as negative because group mean values for WI and CI were lower than 2 and 5, respectively.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under these test conditions, alpha-terpineol was not considered as a sensitiser.
Executive summary:

In a popliteal lymph node assay (PLNA), a group of 10 female Wistar rats were injected subcutaneously with alpha-Terpineol at 5 mg/paw into the right hind footpad while the contralateral footpad was injected with the vehicle (DMSO) alone. Chlorpromazine (CPZ) and barbital were used as positive and negative controls, respectively. Weight (WI) and cellularity (CI) indices for draining PLNs were determined 7 days after treatment. 

Weight (WI) and cellularity (CI) indices for alpha-Terpineol was determined to be 1.32 ± 0.71 and 2.00 ± 3.32, respectively. Alpha-terpineol was classified as negative because group mean values for WI and CI were lower than 2 and 5, respectively.

Under these test conditions, alpha-terpineol was not considered as a sensitiser.