Registration Dossier
Registration Dossier
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EC number: 274-407-9 | CAS number: 70210-10-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from October 6 to 9, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study well conducted. However, there are some differences with respect to indications in the CLP Regulation (EC 1272/2008), as detailed below.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Principles of method if other than guideline:
- Basic method described in the Federal Register 1973, vol. 38, no. 187, 1500, 41.
Deviations with respect to indications in the CLP Regulation (EC 1272/2008): no 48-h observation, but only 24- and 72-h; termination after 72-h and no 14-day observation; exposure to test material on both abraded and intact skin. - GLP compliance:
- no
Test material
- Reference substance name:
- Disperse Orange 080
- IUPAC Name:
- Disperse Orange 080
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leics.
- Weight at study initiation: 2.18 - 2.94 kg.
- Housing: individually in suspended metal cages.
- Diet: ad libitum.
- Water: ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C.
- Air changes: 20 per hour.
- Photoperiod: 12 hours light, 12 hours dark.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 50 % solution/suspension prepared in sterile distilled water.
- Duration of treatment / exposure:
- 24 hours.
- Observation period:
- Up to 72 hours after the test material application.
- Number of animals:
- 6 animals.
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2.
- Type of wrap if used: 2.5 cm2 of absorbent lint B.P.C. backed by a 2.5 cm2 of polyethene with a final backing of 4 cm2 of lint.
REMOVAL OF TEST SUBSTANCE
- Washing: by gentle swabbing with cotton wool soaked in lukewarm water.
- Time after start of exposure: 24 hours.
SCORING SYSTEM
Erythema and eschar formation
0 no erythema
1 very light erythema (barely perceptible)
2 well defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth)
Edema formation
0 no edema
1 very slight edema (slightly perceptible)
2 slight edema (edges of area well-defined by dfinite raising)
3 moderate edema (raised approximately 1mm)
4 severe edema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Results upon application on intact skin
| skin reaction | reading hours | rabbit number | |||||
| 1 | 2 | 3 | 4 | 5 | 6 | ||
| erythema and eschar | 24 | 1 | 1 | 0 | 1 | 1 | 1 |
| 72 | 1 | 0 | 0 | 1 | 0 | 1 | |
| oedema | 24 | 1 | 1 | 0 | 1 | 1 | 1 |
| 72 | 0 | 0 | 0 | 0 | 0 | 0 | |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- According to the CLP Regulation (EC 1272/2008) the substance is considered as non-irritant to the skin of rabbits.
- Executive summary:
Method
Study in 6 rabbits by occlusive application of test material under a composite patch on dorsal/flank clipped skin, both abraded and intact. Exposure to the test material (24-h), then removal of patches and residuals. Observation and scoring at 24 h and 72 after application. Scoring of skin reactions based on Draize scale (1959).
Result
Local signs were erythema and oedema. Barely perceptible erythema/escahr and oedema were seen at 24 -h observation, decreasing or disappearing at 72 -h observation. A score was associated to each animal, averaging over results at 24, 48 and 72 hours (48 -h data assumed to be equal to the highest value between 24 and 72 -h). The highest average score, i.e. 1, was seen in 3/6 animals associated to erythema.
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