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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study without detailed documentation

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: not specified
Deviations:
not applicable
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Trisodium hexafluoroaluminate
IUPAC Name:
Trisodium hexafluoroaluminate
Constituent 2
Reference substance name:
Trisodium hexafluoroaluminate
EC Number:
237-410-6
EC Name:
Trisodium hexafluoroaluminate
Cas Number:
13775-53-6
IUPAC Name:
13775-53-6
Details on test material:
- Name of test material (as cited in study report): cryolite
- Physical state: Solid
- Analytical purity: >95%
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 1% aqueous carboxymethyl cellulose
Concentration / amount:
Intradermal induction: 10% test substance formulation
Topical application: 50% test substance formulation
Challenge: 50% test substance formulation
Challengeopen allclose all
Route:
other: Not reported
Vehicle:
other: 1% aqueous carboxymethyl cellulose
Concentration / amount:
Intradermal induction: 10% test substance formulation
Topical application: 50% test substance formulation
Challenge: 50% test substance formulation
No. of animals per dose:
Test group = 10 animals
Control group = 5 animals
Details on study design:
RANGE FINDING TESTS: Topical induction was performed in the pretest to observe dermal reactions. Since no dermal reactions were observed after topical induction in the pretest (cryolite concentration up to 50%), during the main test, local irritation of the shaved skin of the flank was induced by topical epidermal treatment with 0.5 mL 10% sodium laurylsulfate in vaseline on Day 7.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal induction and epidermal induction)
- Exposure period: Single exposure for intradermal induction and 48 hours for epidermal induction.
- Test groups: 1
- Control group: 1
- Site: Skin of the scapular region for intradermal induction and shaved flank for epidermal induction.
- Frequency of applications: 2 (1 intradermal and 1 epidermal)
- Duration: 3 weeks
- Concentrations: 10% test substance formulation for intradermal induction and 50% test substance formulation for epidermal induction.


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: Not reported
- Test groups: 1
- Control group: 1
- Site: At the induced flank sites
- Concentrations: 50% substance formulation
- Evaluation (hr after challenge): Not reported
Challenge controls:
Control animals received the vehicle only during inductions (Day 1 and Day 8) and a 50% substance formulation at challenge.
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Vehicle:
other: Not applicable
Concentration:
Not applicable
No. of animals per dose:
Not applicable
Details on study design:
Not applicable
Positive control substance(s):
other: Not applicable
Statistics:
Not applicable

Results and discussion

Positive control results:
Not reported

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: overall conclusion
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions were observed
Remarks on result:
other: Reading: other: overall conclusion. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No skin reactions were observed.
Reading:
other:
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No skin reactions were observed
Remarks on result:
other: Reading: other:. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No skin reactions were observed.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information