Commiphora myrrha, ext.

Endpoint summary

Description of key information

In an GLP study conducted in compliance with OECD guideline 4442B with the registered substance, an EC1.6 value will be provided (study on going).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

On going study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Type of study:

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

Species:

mouse

Strain:

other: CBA/J (CBA/JRj)

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier Labs, Le Genest-Saint-Isle, France.
- Age at study initiation: 8 weeks
- Weight at study initiation: 20.2-23.8 g
- Housing: Animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood wood flakes.
- Diet: Teklad Global 16% Protein Rodent Diet (Envigo, 2016), ad libitum
- Water: Drinking water (tap water from public distribution system), ad libitum
- Acclimation period: at least5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 10 changes/h
- Photoperiod: 12 h dark / 12 h light

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

On going study

No. of animals per dose:

On going study

Details on study design:

Day 1

The weight of each animal is recorded and the thickness of the right ear of each animal of the vehicle control and treated groups is measured using a micrometer.

Open application of 25 µL of the appropriate dilution of the test item, the vehicle alone, or the positive control (as appropriate), are done to the dorsum of each ear. The test item is spread over the entire dorsal of the ear using the tip of the micropipette.

• GROUP 1 (Negative control): 25 µL of the vehicle
• GROUP 2 (Treated): 25 µL of the appropriate dilution of the test item (low concentration).
• GROUP 3 (Treated): 25 µL of the appropriate dilution of the test item (medium concentration).
• GROUP 4 (Treated): 25 µL of the appropriate dilution of the test item (high concentration).

Day 2

The application procedure carried out on day 1 is repeated.

Day 3

The thickness of the right ear is measured and then the application procedure carried out on day 1 is repeated.

Day 4

No treatment.

Day 5

0.5 mL (5 mg/mouse) of BrdU (10 mg/mL) solution is injected intra -peritoneally

Day 6

The weight of each animal is recorded.
Approximately 24 hours (24 h) after BrdU injection, the mice are sacrificed with an intraperitoneal injection of sodium pentobarbital (Dolethal®).
The thickness of the right ear of each animal of the vehicle control and treated groups is measured using a micrometer and punch biopsies of 8 mm in diameter. The apical area of both ears is prepared and weighed in order to assess the irritation potential of the test item.

For each individual animal of each group the draining auricular lymph nodes are excised.

Statistics:

No data

Positive control results:

On going studies

Key result

Parameter:

other: EC1.6

Remarks on result:

other: on-going

Key result

Parameter:

SI

Variability:

To be performed

Test group / Remarks:

To be performed

Remarks on result:

other: on-going

Key result

Parameter:

SI

Variability:

To be performed

Test group / Remarks:

To be performed

Remarks on result:

not measured/tested

Parameter:

SI

Variability:

To be performed

Test group / Remarks:

To be performed

Remarks on result:

other: on-going

Study on-going

Interpretation of results:

other: Study on-going

Conclusions:

Study on-going

Executive summary:

Study on-going

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Reason / purpose for cross-reference:

data waiving: supporting information

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Study on going