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EC number: 233-117-2 | CAS number: 10039-33-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- October 18th to October 25th 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Justification for Read Across is given in Section 13 of IUCLID.
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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf.
- Weight at study initiation: 2 - 3 kg.
- Housing: individually in metal cages.
- Diet: rabbit food NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water: ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C.
- Humidity 55 ± 15 %.
- Air changes: approximately 15 per hour.
- Photoperiod: 12 hrs 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).
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
Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised more than 1 mm) 3
Severe oedema (raised > 1 mm and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: #5, #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: shaved skin
- Irritant / corrosive response data:
- Necrosis and extended erythema was observed in all 6 animals.
Any other information on results incl. tables
Table: 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: individual Score
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:
- other: classified as a skin irritant according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- The test material is considered to be a skin irritant.
- 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.
All rabbits presented a score (mean 24/48/72 h) for erythema equal to 3 (intact skin). The following scores for edema were obtained for the intact skin of rabbits: 3.33 (#1), 2.33 (#2, #3), 2 (#4) and 3 (#5, #6). Both edema and erythema were not reversible within the 7 -day observation period.
The test material is considered to be a skin irritant.
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