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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
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.

Test material

Constituent 1
Chemical structure
Reference substance name:
Reference substance 001
EC Number:
604-086-6
Cas Number:
138577-01-2
Molecular formula:
Al.Cs.F
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material: Cesium Fluoro Aluminate Complex
- Purity: 99.5%
- Batch: 604/013
- Physical state: White amorphous powder
- Storage condition of test material: At room temperature in the dark
- Expiration date of the lot/batch: 22 May 2001

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
- Induction:
intradermal injection: 0.02%
epidermal induction: 50%

- Challenge: 50%
Challengeopen allclose all
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

Results and discussion

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.

In vivo (non-LLNA)

Resultsopen allclose all
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

Applicant's summary and conclusion

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.