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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:
weight of evidence
Study period:
21st to 23rd September 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. No data on purity or GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
- Test substance left on for 24 hours.
- Occlusive dressings used.
- Observations up to 48 hours only as test was terminated for humane reasons.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
EC Number:
239-594-3
EC Name:
Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
Cas Number:
15546-11-9
Molecular formula:
C18H28O8Sn
IUPAC Name:
methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate
Details on test material:
- Name of test material (as cited in study report): TK 11.637
- Physical state: liquid
- Lot/batch No.: 250-252

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: raised on site
- Age at study initiation: no data
- Weight at study initiation: 2-3 kg
- Housing: housed individually in metal cages numbered by ear tags
- Diet (e.g. ad libitum): standard rabbit food - NAFAG, No. 814, Gossau SG; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10%
- Photoperiod (hrs dark / hrs light): 12 hours per day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
48 hours
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:
- Type of wrap if used: covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.


SCORING SYSTEM:

Erythema and eschar formation

No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe,erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Total possible erythema score: 4


Edema formation

No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4

Total possible edema score: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
3.3
Max. score:
4
Reversibility:
other: test was terminated after 48 hours for humane reasons, therefore would not be considered reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
3.5
Max. score:
4
Reversibility:
other: test was terminated after 48 hours for humane reasons, therefore would not be considered reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
3
Max. score:
4
Reversibility:
other: test was terminated after 48 hours for humane reasons, therefore would not be considered reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
3
Max. score:
4
Reversibility:
other: test was terminated after 48 hours for humane reasons, therefore would not be considered reversible
Irritant / corrosive response data:
primary irritation index according to the US UPA evalation system = 28.0 / 4 = 7.0 (maximal pollible value = 8)

Any other information on results incl. tables

The erythema was greater than the application patch on all application sites.

The test material was found to cause an extreme irritation when applied to intact and abraded rabbit skin.

The test was ended after the second reading for humane reasons.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test material was found to cause an extreme irritation when applied to intact and abraded rabbit skin. Thus it is considered to be corossive.
Executive summary:

Under the conditions of the present experiment the test material was found to cause an extreme irritation when applied to intact and abraded rabbit skin.

Classification according to the dangerous substances Directive 67/548/EEC and also Regulation (EC) No 1272/2008 is not technically possible as only 24 & 48 hour results are given. However the study was terminated after 48 hours for humane reasons, as the test material was found to cause an extreme irritation when applied to intact and abraded rabbit skin. Thus it is appropriate to classify the substance in accordance with Directive 67/548/EEC as well as Regulation (EC) No 1272/2008 as corrosive to the skin.