Arctium lappa, ext.

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21. Jan. 2004 - 2. April 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented GLP-Study. All data are given. However the tested test item contained additionally Glycerin (40%) which is used in that form in the final formulations in cosmetics.

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 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes (incl. QA statement)

Remarks:

RCC

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Arctium lappa, ext.

EC Number:

281-658-8

EC Name:

Arctium lappa, ext.

Cas Number:

84012-13-5

IUPAC Name:

Arctium lappa, ext.

Details on test material:

- Name of test material (as cited in study report): Klettenextrakt (Sample ID: 12230)
- Physical state: Greenish liquid
- Expiration date of the lot/batch: 21-MAY-2004
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: in original container at 5+-3°C, away from direct sunlight

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Herlan Netherlands, Horst, The Netherlands
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 16-24 g
- Housing: individually in Makrolon type-2 cages with standard softwood bedding
- Diet: Pellet standard Kliba 3433 rat/mouse maintenance diet, ad libitum
- Water: Community tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3°C
- Humidity: 30-70%
- Air changes (per hr): 10-15
- Photoperiod: 12 hrs dark / 12 hrs light

Study design: in vivo (LLNA)

Vehicle:

other: ethanol:water (7:3 (v/v))

Concentration:

Pre-test: 5%, 10%, 25% and 50%
Main test: 1%, 5% and 25% (w/w) in ethanol:water, 7:3 (v/v)
Test item weighted and vehicle added. Dilutions prepared individually using magnetic stirrer. Test item formulations made freshly before each dosing occasion and not more than 4 hours prior to application.

No. of animals per dose:

Pre-test: 2
Main-test: 16
Test groups: 3 (4 animals per group)
Control group: 1 (4 animals)

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

Mean values and standard deviations calculated for body weight.

Results and discussion

Positive control results:

The control substance was found to be a skin sensitizer and an EC3 value of 11.7% (w/v) was derived.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1

Test group / Remarks:

1% (w/w) / 4 animals per group

Results 2

Parameter:

SI

Value:

0.9

Test group / Remarks:

5 % (w/w) / 4 animals per group

Results 3

Parameter:

SI

Value:

1.1

Test group / Remarks:

25 % (w/w) / 4 animals per group

Any other information on results incl. tables

Incorporation of ³H-methyl Thymidine: no dose-response relation observed.

Viability/mortality: no deaths occurred

Clinical signs: no signs observed in any animals of control group, 1% and 5% concentration. In the 25% group, a slight ear erythema was observed at both dosing sites in all animals, persisting for a total of 3 days.

Body weight: in the normal range at all animals.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The tested test item contained additionally Glycerin which is used in that form in the final formulations in cosmetics. However the test should still be relevant for the REACH registration as
1. the registered substance is marketed in the formulation with 40% Glycerin only.
2. A sensitizising effect of the substance for registration can be excluded until a concentration of 15% in Ethanol:Water, 7:3 (v/v) because of the test item contained 40% Glycerin.
3. The test item is identical to the marketed mixture which is used in that way in the cosmetic industry directly.
4. No sensitizising effects were observed on humans through its use in cosmetics.
5. The relevant content of Arctiin of test item in this study is in the range of Arctiin contents of the substance for registration.
6.. The available study is sufficient to characterise the substance sensitisation potential.

The substance registered is considered not a skin sensitizer based on the results of the study according to OECD Guideline 429.