Ledum palustre, ext.

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 February 2016 to 01 March 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA): BrdU-ELISA

Test material

Test material information

Constituent 1

Reference substance name:

Ledum palustre, extract

EC Number:

289-997-3

Cas Number:

90063-39-1

Molecular formula:

UVCB substance, not relevant.

IUPAC Name:

Ledum palustre, extract

Test material form:

liquid

Details on test material:

UVCB substance : see composition at section 1

Specific details on test material used for the study:

Groups of four mice were treated with the test item at 100% and diluted at 50% and 25% in the vehicle Dimethyl formamide (DMF). The mice were treated by daily application of 25 µL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.

In vivo test system

Test animals

Species:

mouse

Strain:

CBA:J

Sex:

female

Details on test animals and environmental conditions:

Female CBA/J (CBA/JRj) strain mice were supplied by Elevage Janvier Labs. On receipt the animals were randomly allocated to cages. The animals were nulliparous and non-pregnant. After an acclimatisation period of at least five days under stabling and nutritional conditions identical to those of the test, the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
At the start of the main study the animals were 9 weeks old.

The animals were weighed at the beginning and at the end of the study.

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

No. of animals per dose:

Three groups of four animals were treated of the test at 100% (as supplied) and diluted at concentrations of 25% and 50% in Dimethyl formamide (DMF). A further group of four animals was treated with DMF.

Details on study design:

Three groups of four animals were treated for three consecutive days (D1, D2, D3) with 50 µL (25 µL per ear) of the test at 100% (as supplied) and diluted at concentrations of 25% and 50% in Dimethyl formamide (DMF). A further group of four animals was treated with DMF.

Positive control substance(s):

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

other: vehicle

Results and discussion

Positive control results:

In conclusion, in view of these results, under these experimental conditions, the substance α -Hexylcinnamaldehyde in accordance with the Regulation (EC) No. 1272/2008 has to be classified in category 1 “Skin sensitisation”.
The signal word “Warning” and hazard statement H317 “May cause an allergic skin reaction” are required.

In vivo (LLNA)

Results

Key result

Parameter:

SI

Value:

ca. 0.83

Variability:

The Stimulation Index (SI) calculated by individual approach was 0.82, 0.90 and 0.83 for the treated groups at 25%, 50% and 100%, respectively.

Remarks on result:

other:

Remarks:

The results obtained, in these experimental conditions, enable to conclude that the test item Teinture mère de Ledum palustre – code L12C does not have to be classified in category 1, in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The results obtained, in these experimental conditions, enable to conclude that the test item Teinture mère de Ledum palustre – code L12C does not have to be classified in category 1, in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.