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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study; GLP certificate is not attached to the study report. Minor deviations with no effect on the study results: According to the guideline, individual animal weights should be stated at the conclusion of test. This is missing in the report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, see "rational of reliability"
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diantimony pentoxide
EC Number:
215-237-7
EC Name:
Diantimony pentoxide
Cas Number:
1314-60-9
Molecular formula:
O5Sb2
IUPAC Name:
diantimony pentoxide

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd., Bicester
- Age at study initiation: approx. 13 to 15 weeks old
- Weight at study initiation: 2.56 to 2.75 kg
- Housing: On arrival rabbits were accommodated in cages that conform with the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989). No bedding was provided. Where practicable, hay and plastic in-cage shelters were provided for environmental enrichment.
- Diet (ad libitum): Global Diet 2030 (Harlan Teklad, Bicester, UK)
- Water (ad libitum): Mains water
- Acclimation period: 12 to 19 days; the condition of the animals was assessed daily throughout the acclimatisation period.

ENVIRONMENTAL CONDITIONS
- Temperature: 16 to 22 °C
- Relative humidity: 40 to 70 %
- Air changes: At least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on test animals and environmental conditions were stated.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Application of 500 mg of powdered EFR-6N (Diantimony pentoxide)

VEHICLE
- Amount(s) applied (volume or weight with unit): Each site was moistened by application of purified water (appeoxiamtely 0.1 mL) immediatly before the application of the test substance.
No further information on amount/concentration applied was stated.
Duration of treatment / exposure:
One animal (sentinel) was treated sequentially for three minutes, one hour, and four hours with the test substance on three different sites.
Two additional animals were treated for four hours with the test substance.
Observation period:
1 hour and then approx. 24, 48 and 72 hours after patch removal; dermal sites of the sentinel rabbit were also inspected immediatly after patch removal
Number of animals:
3 males rabbits
Details on study design:
TEST SITE
- Area of exposure: 30 X 20 mm areas on the closely clipped dorsum
- Type of wrap if used: The application site was coverd by a dense gauze patch (30 X 20 mm). This in turn was covered by a larger gauze patch (40 X 40 mm) and an open weave, elasticated adhesive compression bandage which was wrapped firmly around the torso to secure the applied doses and patches in the correct positions.

REMOVAL OF TEST SUBSTANCE
Each dermal site was lightly brushed clean of any solid residues and swabbed with moist cotton wool.
- Time after start of exposure: Sentinel: after 3 mintues, 1 hour and 4 hours; Other two animals after 4 hours.

SCORING SYSTEM: Draize scoring system

EXPERIMENTAL OBSERVATIONS:
Clinical signs: The general state of health of each rabbit was checked twice daily.
Body weights: Each rabbit was weighed on the day before dosing coomenced.
No further information on study design was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Results after 4 hour exposure.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Results after 4 hour exposure.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Results after 4 hour exposure.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Results after 4 hour exposure.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Results after 4 hour exposure.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Results after 4 hour exposure.
Irritant / corrosive response data:
No dermal response to treatment was observed in any animal throughout the observation period.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as skin irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.