Dilithium glutarate

Endpoint summary

Description of key information

Skin Sensitization – Not senstizing in mouse LLNA (OECD TG 429) read across from dilithium adipate

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:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Specific details on test material used for the study:

- 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

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

Vehicle:

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

Concentration:

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: 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
CHALLENGE EXPOSURE- 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):

not specified

Key result

Parameter:

SI

Value:

1

Test group / Remarks:

2% w/w test item

Key result

Parameter:

SI

Value:

0.9

Test group / Remarks:

15% w/w test item

Key result

Parameter:

SI

Value:

0.6

Test group / Remarks:

30% w/w test item

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.

Interpretation of results:

GHS criteria not met

Conclusions:

The Murine Local Lymph Node Assay to assess the skin sensitization potential of Dilithium Adipate was negative. This finding does not warrant the classification of Dilithium Adipate as a skin sensitizer under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).

Executive summary:

Dilithium Adipate was examined for its potential to be a skin sensitizer using the Murine Local Lymph Node Assay. Following a preliminary range finding test, 5 CBA mice were treated by dermal application of 2, 5, and 15% w/w Dilithium Adipate in acetone/olive oil (4:1 v/v) to induce sensitization. No indication of sensitization was noted. This finding does not warrant the classification of Dilithium Adipate as a skin sensitizer under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).

Reference 2

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

See attached justification

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
See field "Attached Justification" for read-across justification

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See field "Attached Justification" for read-across justification

3. ANALOGUE APPROACH JUSTIFICATION
See field "Attached Justification" for read-across justification

4. DATA MATRIX
See field "Attached Justification" for read-across justification

Reason / purpose for cross-reference:

read-across source

Parameter:

SI

Value:

1

Test group / Remarks:

2% w/w test item

Parameter:

SI

Value:

0.9

Test group / Remarks:

15% w/w test item

Parameter:

SI

Value:

0.6

Test group / Remarks:

30% w/w test item

Interpretation of results:

GHS criteria not met

Conclusions:

The skin sensitization potential of the target substance indicated in the test material information is expected to not meet GHS criteria for classification under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).

Executive summary:

Dilithium Glutarate is not expected to be a skin sensitizer based on negative results in the Murine Local Lymph Node Assay from the Source Study on Dilithium Adipate. As explained in the justification for type of information, the difference of one carbon chain length between the target and source substance is unlikely to lead to differences in skin sensitization potential. Therefore the classification of Dilithium Glutarate as a skin sensitizer is not warranted under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The sensitization potential of dilithium glutarate has been evaluated based on data of a structurally similar substance in a manner similar or equivalent to currently established OECD guidelines. Sensitizing properties have not been demonstrated and classification is not warranted.

Justification for classification or non-classification

Dilithium glutarate is not considered a dermal sensitizer based on read-across to data of a structurally similar substance, dilithium adipate. Dilithium Adipate was examined for its potential to be a skin sensitizer using the Murine Local Lymph Node Assay. Following a preliminary range finding test, 5 CBA mice were treated by dermal application of 2, 5, and 15% w/w Dilithium Adipate in acetone/olive oil (4:1 v/v) to induce sensitization. No indication of sensitization was noted. As the read-across is considered valid, this finding does not warrant the classification of dilithium glutarate as a skin sensitizer under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).