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EC number: 268-500-3 | CAS number: 68109-88-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- According to OECD 404
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 October 1982 to 25 October 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Procedure similar to the proposed guidelines of the United States EPA, Paragraph 163.81-5 “Primary dermal irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978
- Deviations:
- yes
- Remarks:
- : the procedure was based upon the guideline but was not in every part identical.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : the animals were exposed to the test material for 24 hours in an occlusive fashion; there was no evaluation 60 minutes after patch removal and the observation period lasted only 7 days.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- EC Number:
- 268-500-3
- EC Name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- Cas Number:
- 68109-88-6
- Molecular formula:
- C28H48O8Sn
- IUPAC Name:
- ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- Test material form:
- other: liquid that tends to crystallise
- Details on test material:
- - Appearance: clear liquid, tends to crystallise
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Housing: Individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, ad libitum.
- Water (e.g. ad libitum): ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): Approximately 15 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light per day.
IN-LIFE DATES: From: 18 October 1982 To: 25 October 1982
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- - Volume: 0.5 mL of the test material
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6; 3 male and 3 female
- Details on study design:
- SITE PREPARATION:
-24 hours before exposure, the flanks of the test animals were shaved using an electric clipper. Immediately prior to treatment, the skin on one side was slightly scarified by means of a "Schroepfschnaepper".
TEST SITE
- Patch Size: Gauze patches 2.5 x 2.5 cm soaked with the test material were applied to intact and abraded skin sites. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
SCORING SYSTEM: The skin reactions were assessed upon patch removal and during the subsequent 7 day observation period in accordance with the Draize scale (1977).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24 and 72 hour evaluations
- Score:
- 5.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Both shaved and abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Shaved skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.9
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Shaved skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean of 24, 48 and 72 hour evaluations
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Abraded skin
- Irritant / corrosive response data:
- Necrosis and extended erythema was observed in all 6 animals.
Any other information on results incl. tables
Table 1 PII at 24 and 72 hours.
PII = total ÷ 4
| Time After Exposure (hours) | Mean Erythema Scores | Mean Oedema Scores | ||
| Intact Skin | Abraded Skin | Intact Skin | Abraded Skin | |
| 24 | 3.0 | 3.0 | 2.8 | 2.7 |
| 72 | 3.0 | 2.8 | 2.7 | 2.5 |
| Subtotal | 6.0 | 5.8 | 5.5 | 5.2 |
| Total | 22.5 | |||
| PII | 5.6 | |||
Table 2 Individual Scores
Shaved
| Time After Exposure (hours) | Male | Female | Average | |||||
| 1 | 2 | 3 | 1 | 2 | 3 | |||
| Erythema | 24 hours | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 |
| 48 hours | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | |
| 72 hours | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | |
| 4 days | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | |
| 7 days | 3 | 2 | 3 | 2 | 2 | 3 | 2.5 | |
| Oedema | 24 hours | 3 | 3 | 3 | 2 | 3 | 3 | 2.8 |
| 48 hours | 3 | 2 | 2 | 2 | 3 | 3 | 2.5 | |
| 72 hours | 4 | 2 | 2 | 2 | 3 | 3 | 2.7 | |
| 4 days | 4 | 2 | 2 | 2 | 3 | 3 | 2.7 | |
| 7 days | 4 | 2 | 2 | 2 | 2 | 2 | 2.3 | |
| Abraded | ||||||||
| Erythema | 24 hours | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 |
| 48 hours | 2 | 3 | 3 | 3 | 3 | 3 | 2.8 | |
| 72 hours | 2 | 3 | 3 | 3 | 3 | 3 | 2.8 | |
| 4 days | 2 | 3 | 3 | 3 | 3 | 3 | 2.8 | |
| 7 days | 2 | 2 | 3 | 2 | 2 | 2 | 2.2 | |
| Oedema | 24 hours | 2 | 3 | 3 | 2 | 3 | 3 | 2.7 |
| 48 hours | 2 | 2 | 3 | 2 | 3 | 3 | 2.5 | |
| 72 hours | 2 | 2 | 4 | 2 | 3 | 2 | 2.5 | |
| 4 days | 2 | 2 | 4 | 2 | 3 | 2 | 2.5 | |
| 7 days | 2 | 2 | 3 | 1 | 2 | 2 | 2.0 | |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Classified according to EU criteria.
- Conclusions:
- Under the conditions of the study, the test material was shown to cause marked irritation to the skin of rabbits and as such is classified as a category 2 skin irritant in accordance with EU criteria.
- Executive summary:
The skin irritancy potential of the test material was assessed in a GLP compliant in vivo study that was based upon the procedure outlined in the guidelines of the United States EPA, Paragraph 163.81-5 “Primary dermal irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978.
Six New Zealand White rabbits were exposed to the test material in an occlusive fashion for 24 hours on both intact and abraded skin. The skin reactions were evaluated in accordance with the Draize scale at 24, 48 and 72 hours followed by observations after 4 and 7 days.
Under the conditions of this study, the test material produced marked irritation to the skin and as such requires classification as “Category 2, H315: Causes skin irritation” with signal word “Warning” in accordance with EU criteria.
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