[No public or meaningful name is available]

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Avena Sativa leaf/stem extract

IUPAC Name:

Avena Sativa leaf/stem extract

In vivo test system

Study design: in vivo (LLNA)

Vehicle:

other: purified water (Citoxlab Scantox A/S) and Pluronic® PE9200

Details on study design:

The methods used in this study were based on the OECD guideline 429 ”Skin Sensitisation: Local Lymph Node Assay” adopted on 22 July 2010. The CBA/Ca mouse was selected as the test model, according to this guideline.
As EXT. AQ. CONC. PLANTULE AVOINE is a hydrophilic substance, 1% Pluronic® PE9200 was added to dose formulations to ensure maximum exposure in the animals.
Prior to the conduction of the main study (LLNA) a sighting study (irritation/toxicity screen) was performed, to determine the highest dose concentration tolerated in the animals.
The maximum dose for the sighting study was determined based on the OECD guideline 429 which recommends dosage at 100%, if possible. The low dose was set at 25%.

Results and discussion

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

5.1

Test group / Remarks:

100% Avena Sativa leaf/stem extract

Results 2

Key result

Parameter:

SI

Value:

1.3

Test group / Remarks:

75% Avena Sativa leaf/steam extract

Results 3

Key result

Parameter:

SI

Value:

0.8

Test group / Remarks:

50% Avena Sativa leaf/steam extract

Applicant's summary and conclusion

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

It cannot be concluded whether the hair loss observed in the 75% and 100% dose groups was not caused by excessive grooming due to discomfort, though no skin irritation was observed. Dilutions of 50% v/v and 75% v/v EXT. AQ. CONC. PLANTULE AVOINE were shown to have no sensitization potential in this Local Lymph Node Assay in Mice. They are thus characterised as non-sensitizing. A dilution of 100% v/v of EXT. AQ. CONC. PLANTULE AVOINE was shown to have sensitization potential in the Local Lymph Node Assay in Mice and is thus characterised as a sensitizer.

Executive summary:

The objective of this study was to determine the skin sensitisation potential of pure and dilutedEXT. AQ. CONC. PLANTULE AVOINE, administered daily by dermal application on the dorsal surface of the pinna of both ears to mice for 3 days. The test item is an industrial chemical.

The methods used in this study were based on the OECD guideline 429 ”Skin Sensitisation: Local Lymph Node Assay” adopted on 22 July 2010. The CBA/Ca mouse was selected as the test model, according to this guideline.

The dose levels ofEXT. AQ. CONC. PLANTULE AVOINEfor the Local Lymph Node Assay in Mice were determined based on an irritation/toxicity screen (sighting study) whichincluded the following parameters:Ear thickness measurements and ear biopsy weights.

AsEXT. AQ. CONC. PLANTULE AVOINEisa hydrophilic substance, 1% Pluronic® PE9200 was added to dose formulations to ensure maximum exposure in the animals.

In the Local Lymph Node Assay (main study), mice were topically dosed with 3 concentrations of the test item on the dorsal surface of the pinna of both ears for three days, applying a total dose volume of 50 µL/animal/day. Lymphoproliferation was measured as incorporation of tritiated methyl thymidine (³HTdR) into the DNA of dividing lymphocytes on the 6^thday of the main study.

The study was performed in 7-8 week old female CBA/CaOlaHsd brown mice.

The animals in the sighting study were treated as follows:

Group	Days of dosing	Test item	Animal Nos	Colour code
			Female
1	1-3	Purified water with 1% v/vPluronic®PE 9200 (Vehicle control)	1-2	White
2	1-3	25% v/v of Plantule Avoine	3-4	Cyan
3	3-5	100% v/v of Plantule Avoine	5-6	Green

Dose escalation was performed as no adverse clinical signs and no excessive irritation at the application sites were observed on Days 1-3.