Registration Dossier
Registration Dossier
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EC number: 686-526-7 | CAS number: 171611-11-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017.9.28-2017.12.20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Lithium bis(fluorosulfonyl)imide
- EC Number:
- 686-526-7
- Cas Number:
- 171611-11-3
- Molecular formula:
- F2 H N O4 S2 . Li
- IUPAC Name:
- Lithium bis(fluorosulfonyl)imide
- Test material form:
- solid: bulk
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: ElmSam:HA
- Sex:
- male
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % (w/v) test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No mortality was observed relating to test substance treatment
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%(w/v)test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No mortality was observed relating to test substance treatment
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- sterilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No mortality was observed relating to test substance treatment
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- sterilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No mortality was observed relating to test substance treatment
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%(W/V) DNCB
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No mortality was observed relating to test
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%(W/V) DNCB
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No Mortality was observed relating to test
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- At the 24 and 48 hours after challenge with test substance of 25 %(w/v), the
sensitisation index (mean score of skin reaction) and frequency index (sensitisation
rate) were '0.0', '0.0 %' and '0.0', '0.0 %' at 24 and 48 hours for the test substance. In
the positive control group, the sensitisation index (mean score of skin reaction) and
frequency index (sensitisation rate) were '1.4', '90.0 %' and '0.6', '60.0 %' .
These results indicate that LiFSI is considered to have minimal skin sensitizing
potency (Class I) considering no skin reaction in guinea pigs by Buehler test under
the conditions of this study.
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