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Diss Factsheets

Administrative data

Description of key information

In a Maximisation test with guinea pigs with the read-across candidate cesium fluoro aluminate complex no skin sensitisation was observed. Based on this, cesium tetrafluoroaluminate is also considered to be not sensitising to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
A maximization test is available
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 13 July 1998 to 30 September 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
At the time of testing (1998), the LLNA method was not yet adopted as OECD Guideline and not yet identified as the standard information requirement.
For this reason the use of the guinea pig maximisation test (GPMT) was considered te be acceptable.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd, Basel, Switzerland
- Age at study initiation: approx. 6 weeks old
- Weight at study initiation: <500 g
- Housing: 5 animals/cage
- Diet: Free access to standard guinea pig diet, including ascorbic acid (1600 mg/kg); LC23-B, pellet diameter 4 mm (Hope farms, Woerden, The Netherlands).
- Water: free access to tap-water, diluted with decalcified water.
- Acclimation period: at least 5 days before start of the treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled at 21°C
- Humidity (%): controlled at 50%
- Air changes (per hr): approximately 15 room air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity.

IN-LIFE DATES: From: 13 July 1998 to 21 August 1998
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
- Induction:
intradermal injection: 0.02%
epidermal induction: 50%

- Challenge: 50%
Route:
epicutaneous, occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
- Induction:
intradermal injection: 0.02%
epidermal induction: 50%

- Challenge: 50%
No. of animals per dose:
Experimental group: 10 females
Control group: 5 females
(females were nulliparous and non-pregnant).
Details on study design:
RANGE FINDING TESTS:
- For intradermal induction: 0.02% was selected for the main study considering as the highest concentration that did not cause local necrosis.
- For epidermal induction: No signs of irritation were observed at the highest test concentration tested (50%). Therefore the test site of all animals was treated with 10% SDS approximately 24 hours before the epidermal induction in the main study, to provoke a mild inflammatory reaction.
- For epidermal challenge: 50% was selected for the main study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Day 0 and Day 7/8
- Site: shoulder region
- Concentrations: 0.02 % (intradermal), 50 % (epidermal)

Intradermal injection/day 0
The scapular region was clipped and three pairs of intradermal injections (0.1 ml/site) were made in this area as follows:
A) A 1:1 w/w mixture of Freund's Complete Adjuvant with water for injection
B) The test substance at a 0.02% concentration.
C) A 1:1 w/w mixture of the test substance, at twice the concentration used in (B) and Freund's Complete Adjuvant
The control animals were treated as the experimental animals, except that, instead of the test substance, the vehicle (1% carboxymethyl cellulose) was adminstered. On Day 3, the dermal reactions were assessed for irritation.

Epidermal applications
One week later (Day 7), the scapular area between the injection sites was clipped and subsequently rubbed with 10% sodium-dodecyl-sulfate (SDS, Boom, Meppel, The Netherlands) in vaseline using a spatula. On Day 8, the 10% SDS treated area was treated with 0.5 ml of a 50% test substance concentration using a Metalline patch (2x3 cm) mounted on Medical tape, which was held in place with Micropore tape and subsequently Coban elastic bandage. The dressing was removed after 48 hours exposure, the skin cleaned of residual test substance and the dermal reactions caused by the epidermal exposure were assessed for irritation.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 hours
- Test groups and Control group: One flank of all animals was clipped and treated by epidermal application of a 50% test substance concentration and the vehicle (0.5 ml each), using Metalline patches (2x3 cm) mounted on Medical tape, which were held in place with Micropore tape and subsequently Coban elastic bandage. The treated sites were assessed for challenge reactions 24 and 48 hours after removal of the dressing.
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 hours

Observations
- Mortality/viability was checked twice daily.
- Toxicity was checked at least once daily.
- Body weights were determined prior to start and at termination of the study.
Challenge controls:
yes (negative controls)
Positive control substance(s):
no
Positive control results:
A reliability check is carried out at regular intervals. The study performed in January/February 1998 showed that a positive response was observed when female Dunkin-Hartley guinea pigs were challenged with 5 and 10% alpha-hexylcinnamicaldehyde concentrations. Therefore it was concluded that the sensitivity of the test animal was acceptable.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5%
No. with + reactions:
10
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
10%
No. with + reactions:
10
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
5%
No. with + reactions:
9
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
10%
No. with + reactions:
10
Total no. in group:
10
Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this study, no evidence was obtained that cesium aluminium fluoride - complex has a skin sensitising potential.
Executive summary:

The skin sensitization potential of cesium aluminium fluoride - complex was investigated in a study performed according to the OECD Testing Guideline No. 406 (Guinea pig maximisation test) and under GLP. The test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 0.02% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with the vehicle (1% aqueous carboxymethyl cellulose) only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals. No evidence was obtained that test substance had caused skin hypersensitivity in the guinea pig, since no response were observed in the experimental animals in the challenge phase. This result indicated a sensitization rate of 0 per cent.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No skin sensitisation studies are available on cesium tetrafluoroaluminate. However, Article 13 of the REACH legislation states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e., applying alternative methods such as in vitro tests, QSARs, grouping and read-across. Data are available on a structural analogue, cesium fluoro aluminate complex.

The skin sensitization potential of cesium fluoro aluminate complex was investigated in a study performed according to the OECD Testing Guideline No. 406 (Guinea pig maximisation test) and under GLP. Test substance concentrations selected for the main study were based on the results of a preliminary study.In the main study, ten experimental animals were intradermally injected with a 0.02% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with the vehicle (1% aqueous carboxymethyl cellulose) only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle.

No skin reactions were evident after the challenge exposure in the experimental and control animals.No evidence was obtained that test substance had caused skin hypersensitivity in the guinea pig, since no response were observed in the experimental animals in the challenge phase.

Based on the results of the study, cesium fluoro aluminate complex is considered to be not sensitising to skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the read-across with cesium fluoro aluminate complex, cesium tetrafluoroaluminate is not considered as sensitising to skin. In accordance to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for sensitisation.