Dilithium sebacate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes (incl. QA statement)

Type of study:

other: Local Lymph Node Assay

Test material

Test material information

Constituent 1

Reference substance name:

Dilithium adipate

EC Number:

242-449-7

EC Name:

Dilithium adipate

Cas Number:

18621-94-8

Molecular formula:

C6H8O4.2Li

IUPAC Name:

dilithium adipate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material: dilithium adipate
- Molecular formula: C6H8O4.2Li
- Molecular weight: 158
- Physical state: white powder
- Analytical purity: 100%
- Lot/batch No.: A049/99
- Expiration date of the lot/batch: 6 March 2018
- Storage condition of test material: At room temperature protected from light

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Makrolon cages containing sterilised sawdust
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, open

Vehicle:

other: Acetone/Olive oil (4:1 v/v)

Induction 2

Concentration / amount:

2, 15 and 30 % test item w/w

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

other: Acetone/Olive oil (4:1 v/v)

Challenge 2

Concentration / amount:

2, 15 and 30 % test item w/w

No. of animals per dose:

5

Details on study design:

RANGE FINDING TESTS: 15 and 30 % test item w/w using 2 animals per concentration

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 days
- Test groups: 5 animals exposed to each concentration
- Control group: 5 animals exposed to the vehicle
- Site: dorsal surface of both ears
- Frequency of applications: Days 1, 2, 3
- Duration: 6 days
- Concentrations: 2, 15 and 30 % test item w/w

SCORE:
Erythema and eschar formation:
No erythema ..............................................................................……………….....................……………………….. 0
Very slight erythema (barely perceptible) ..............................................................……………………………… 1
Well-defined erythema ...................................................................……………………....................……………… 2
Moderate to severe erythema (beet redness) to slight eschar formation (injuries in depth) .........……… 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema .................……… 4

Positive control substance(s):

no

Results and discussion

In vivo (LLNA)

Results

Parameter:

other: Migrated information from in vivo LLNA study

Remarks on result:

other: Reading: other: All readings. Group: test group. Dose level: 2, 15% and 30%. No with. + reactions: 0.0. Total no. in groups: 15.0. Clinical observations: None.

Any other information on results incl. tables

No irritation and no signs of systemic toxicity were observed in any of the animals.

No mortality occurred and no clinical signs of systemic toxicity were observed in the animals of the main study. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.

All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size.

No macroscopic abnormalities of the surrounding area were noted for any of the animals.

Mean DPM/animal values for the experimental groups treated with test item concentrations 2, 15 and 30% were 899, 780 and 584 DPM, respectively. The mean DPM/animal value for the vehicle control group was 911 DPM. The SI values calculated for the item concentrations 2, 15 and 30% were 1.0, 0.9 and 0.6, respectively.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

Dilithium adipate would not be regarded as a skin sensitizer.

Executive summary:

This study is carried out in accordance to OECD guideline 429, EU method B.42 and is GLP compliant. Therefore, it is given reliability rating of 1 (reliable without restrictions). Dilithium adipate would not be regarded as a skin sensitizer.