Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Lack of data on analytical purity of the test substance. Negative controls were not sham-treated during the induction phase.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
yes
Remarks:
Negative controls were not sham-treated during the induction phase. Lack of data on analytical purity of the test substance.
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
niobium oxygen sulfur zinc λ²-stannane
EC Number:
800-035-9
Cas Number:
1374645-21-2
Molecular formula:
Sn1.8Zn0.2Nb2O6.8S0.2 (Sn(2-x)Zn(x)Nb2O(7-y)S(y) with x/2 ≤ y, 0.02 ≤ x ≤ 0.22, 0.01 ≤ y ≤ 0.22)
IUPAC Name:
niobium oxygen sulfur zinc λ²-stannane
Details on test material:
- Name of test material (as cited in study report): Niobium Sulfur Tin Zinc Oxide, EX 1455
- Physical state: solid
- Appearance: powder with lumps
- Analytical purity: no data
- Lot No.: L1903
- Stability under test conditions: The test substance was expected to be stable under the test conditions.
- Storage condition of test material: at room temperature
- Solubility: insoluble

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elm Hill Breeding Labs
- Age at study initiation: young adult
- Weight at study initiation: 352 - 456 g
- Housing: The animals were housed in groups in suspended stainless steel cages with mesh floors or perforated plastic bottoms. Litter paper was placed beneath the cages and changed at least three times per week.
- Diet: Harlan Teklad Global Guinea Pig Diet #2040, portions of approximately 20 g/d
- Water: filtered tap water, ad libitum
- Acclimation period: 15 - 23 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -23
- Humidity (%): 41 - 62
- Air changes (per hr): 13
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 2% (w/v) carboxymethylcellulose (CMC) in distilled water
Concentration / amount:
Induction: 84% (w/w) mixture of the test substance in vehicle
Challenge: 84% (w/w) mixture of the test substance in vehicle
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 2% (w/v) carboxymethylcellulose (CMC) in distilled water
Concentration / amount:
Induction: 84% (w/w) mixture of the test substance in vehicle
Challenge: 84% (w/w) mixture of the test substance in vehicle
No. of animals per dose:
10 (controls), 20 (test groups)
Details on study design:
RANGE FINDING TESTS:
To find a suitable concentration for the challenge, 4 animals were treated with different concentrations in vehicle. Therefore, the fur on the dorsal area and flanks of each guinea pig was removed by clipping. The area was divided in four test sites on each animal. Mixtures of the test substance with the vehicle yield 84%, 63%, 42% and 21%. 400 mg of each concentration was applied to a test site using an occlusive 25 mm Hill Top Chamber. After 6 h exposure, the chambers were removed and the application sites were cleaned. After 24 h, each site was evaluated for erythema.
The highest non-irritating dose was 84% of the test substance in the vehicle. This concentration was used for the challenge application.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 0.4 g of a mixture of the test substance in 2% (w/v) carboxymethylcellulose (CMC) in distilled water
- Site: left side, using an occlusive 25 mm Hill Top Chamber
- Frequency of applications: every 7 d for 3 weeks
- Duration: 6 h
- Concentrations: 84% (w/w)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28
- Exposure period: 6 h
- Test groups: 0.4 g of a mixture of the test substance in 2% (w/v) carboxymethylcellulose (CMC) in distilled water
- Control group (naive): 0.4 g of a mixture of the test substance in 2% (w/v) carboxymethylcellulose (CMC) in distilled water
- Site: right side, using an occlusive 25 mm Hill Top Chamber
- Concentrations: 84% (w/w)
- Evaluation (hr after challenge): 24 and 48 h after patch removal
Challenge controls:
As control group, 10 naive guinea pigs from the same shipment were treated with 84% of the test substance in vehicle for 6 h.
Positive control substance(s):
yes
Remarks:
historical positive control: alpha-hexylcinnamaldehyde

Results and discussion

Positive control results:
The procedures used in this study were validated using the positive control substance alpha-Hexylcinnamaldehyde. The most recent validation of the test system was performed between 11 Oct and 11 Nov 2011. The positive control substance induced positive reactions in 3/10 animals (30%) thus meeting the reliability criteria for the Buehler test (≥ 15%).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
84%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 84%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
84%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 84%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
84%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 84%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
84%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 84%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

During the induction phase, 5/20 test animals showed very faint erythema 24 h after the treatment. These effects were reversible in 4/5 animals after 48 h. In none of the other animals treated with the test substance any effects were observed.

In 3/20 test group animals and 2/10 naive control animals, very faint erythema were observed 24 h after the challenge phase. These effects were reversible at the second reading timepoint 48 h after the challenge. The very faint erythema observed 24 h after the challenge were not considered to be a positive reaction.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified