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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2021.12-2022.2
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2022

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
We conducted this non-LLNA experiment for other regions' registration purpose. And this test was conducted previously which would not justify conducting an additional LLNA due to animal welfare.

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium difluoro(oxalato)borate(1-)
EC Number:
803-919-2
Cas Number:
409071-16-5
Molecular formula:
C2BF2LiO4
IUPAC Name:
Lithium difluoro(oxalato)borate(1-)
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material:
Provided by sponsor, Batch No.:G200810043

- Purity, including information on contaminants, isomers, etc.:
99.80%


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Refrigeration (+2 to +8°C)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Remarks:
Albino, NIH
Sex:
male/female
Details on test animals and environmental conditions:
Species : Guinea Pigs

Strain : Albino, NIH (Dunkin Hartley)

Scientific name : Cavia porcellus

Source : KCC Biolabs
Tumakuru,
Karnataka

No. of animals : Vehicle Control Group: 10 (5 Males + 5 Females)
Treatment Group: 20 (10 Males + 10 Females)

Note: Positive control data from Study No. G23413 was considered for this study and included in the report. The sensitivity and reliability check of the experimental technique was established once in six months.
For pre-study:
1 Male + 1 Female for intradermal induction
1 Male + 1 Female for topical boosting
Age : 10 to 11 weeks at intra-dermal induction

Body weight range at treatment : Males: 327.1 to 437.8 g
Females: 325.7 to 415.4 g

Identification : Guinea pig accession number. Identification of individual animals was by cage card and body markings using turmeric solution / crystal violet solution. The temporary body marking during acclimatization period was done with crystal violet.

Acclimatization : After physical examination for good health and suitability for the experiment, the animals were acclimatized for 7 days before start of the treatment. Females were nulliparous and non-pregnant. Animals were observed once daily during acclimatization period for any abnormalities.


Animals were housed under standard laboratory conditions, air conditioned with adequate fresh air supply (13.4 to 14.3 air changes/hour). Environment: temperature 21 to 23°C relative humidity 65 to 67%, with 12 hours light and
12 hours dark cycle. The maximum and minimum temperature and relative humidity in the experimental room was recorded once daily. The relative humidity in the experimental room was calculated from dry and wet bulb temperature recordings.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.1 % w/v test item in Milli-Q water. A quantity of 0.01 g of test item made up to 10 mL with Milli-Q water and vortexed.
Day(s)/duration:
21 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.1% w/v of test item in Milli-Q
Day(s)/duration:
24 hour
Adequacy of challenge:
not specified
No. of animals per dose:
5 animals / sex in the vehicle control and 10 animals / sex in the test item treated group
Details on study design:
Two groups (5 animals / sex in the vehicle control and 10 animals / sex in the test item treated group) were sensitized with intra-dermal injection and topical application (boosting) and then challenged by topical application. Positive control (2- Mercaptobenzothiazole) data generated in-house under study number G23413 was considered for this study.
For treatment group (G2), 0.1 mL of 1:1 mixture(v/v) of Complete Freund’s Adjuvant (FCA) in Milli-Q water was injected intra-dermally at site 1, 0.1 % w/v test item in Milli-Q water was injected at site 2 and 0.1 % w/v test item in Milli-Q water mixed with 1:1 mixture (v/v) of FCA in Milli-Q water, such that the final concentration of test item injected was same as that in site 2, was injected at site 3 for the treatment group animals. Similarly, for the vehicle control group animals (G1), 1:1 mixture of FCA & Milli-Q water was injected intra-dermally at site 1, Milli-Q water at site 2 and 1:1 mixture of vehicle (Milli-Q water) and FCA -Milli-Q water(1:1 mixture) at site 3.
On day 8, 0.1% w/v of test item in Milli-Q water was transferred on to a
filter paper (size: 2 x 4 cm) and applied on to the clipped area of skin (site of intradermal injection) by an occlusive dressing for 48 hours. Similarly, 0.5 mL of Milli-Q water was used for vehicle control group animals.
On day 22, the vehicle control and treatment group animals were challenged by transfer of 0.1% w/v of test item in Milli-Q water on to a filter paper
(size: 2 x 4 cm) and applied onto the prepared area of skin to the left flank by an occlusive dressing for 24 hours.Similarly 0.5 mL of Milli-Q water was applied on to the prepared area of skin of the right flank. The skin reaction was evaluated at 24 and 48 hours, post challenge using Magnusson and Kligman Grading Scale.
Positive control substance(s):
yes
Remarks:
(2- Mercaptobenzothiazole

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
8% w/v of test item in Milli-Q water
No. with + reactions:
6
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
8% w/v of test item in Milli-Q water
No. with + reactions:
6
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1% w/v of test item in Milli-Q water
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1% w/v of test item in Milli-Q water
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.1% w/v of test item in Milli-Q water
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1% w/v of test item in Milli-Q water
No. with + reactions:
0
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The comparison of the skin reaction (at challenge) of the test item treated animals with those of the concurrent control and positive control group animals showed that the test item “LITHIUM DIFLUORO(OXALATO)BORATE(1-)” is considered as “Non-Sensitizer” to Guinea Pigs under the stated experimental conditions and it is “Unclassified” as per Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 2021.
Executive summary:

The test item, LITHIUM DIFLUORO(OXALATO)BORATE (1-) was tested for its skin sensitization potential in Guinea Pigs using Magnusson and Kligman Test.


Two groups (5 animals / sex in the vehicle control and 10 animals / sex in the test item treated group) were sensitized with intra-dermal injection and topical application (boosting) and then challenged by topical application. Positive control (2- Mercaptobenzothiazole) data generated in-house under study number G23413 was considered for this study.


For treatment group (G2), 0.1 mL of 1:1 mixture(v/v) of Complete Freund’s Adjuvant (FCA) in


On day 8, 0.1% w/v of test item in Milli-Q water was transferred on to a
filter paper (size: 2 x 4 cm) and applied on to the clipped area of skin (site of intradermal injection) by an occlusive dressing for 48 hours. Similarly, 0.5 mL of Milli-Q water was used for vehicle control group animals.


On day 22, the vehicle control and treatment group animals were challenged by transfer of 0.1% w/v of test item in Milli-Q water on to a filter paper
(size: 2 x 4 cm) and applied onto the prepared area of skin to the left flank by an occlusive dressing for 24 hours.Similarly 0.5 mL of Milli-Q water was applied on to the prepared area of skin of the right flank. The skin reaction was evaluated at 24 and 48 hours, post challenge using Magnusson and Kligman Grading Scale.


There were no clinical signs, pre-terminal deaths or skin reactions at 24 and 48 hours, post challenge in both vehicle control and treatment group.


In the positive control (2- Mercaptobenzothiazole) study (Stu


The comparison of the skin reaction (at challenge) of the test item treated animals with those of the concurrent control and positive control group animals showed that the test item “LITHIUM DIFLUORO(OXALATO)BORATE (1-)” is considered as “Non-Sensitizer” to Guinea Pigs under the stated experimental conditions and it is “Unclassified” as per Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 2021.