Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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:
- March, 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Source study has a Klimisch Score = 2.
For further information see the read across justification attached in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
- Principles of method if other than guideline:
- Code of Federal Regulations Title 16, Section 1500.41
- GLP compliance:
- no
Test material
- Reference substance name:
- Analogue Substance 01
- IUPAC Name:
- Analogue Substance 01
- 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: Buxted Rabbit Co. Ltd.
- Weight at study initiation: 2.0 kg
- Housing: individually in grid floor cages in a single room
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Photoperiod: natural lighting conditions
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- 24, 72 h and 7 d (if any irritation was apparent at the 72 h reading).
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm × 2.5 cm
- Type of wrap if used: gauze pads (2.5 cm × 2.5 cm) were applied. The patches were secured by adhesive strapping and the whole trunk further occluded with a stockinette bandage.
SCORING SYSTEM:
Erythema and eschar formation:
0 no erythema
1 very slight erythema (barely perceptible)
2 well-defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (inluries in depth)
Oedema formation:
0 no oedema
1 very slight oedeina (bareiy pereeptible)
2 slight oedema (edges of area well-defined by definite raising)
3 moderate oedema (raised approximately 1 mm)
4 severe oedema (raised more than 1 mm and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No signs of irritation were noted on both intact and abraded skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritant to the rabbit skin.
- Executive summary:
Method:
Skin irritation potential was tested as described into the Federal Register 1973, Volume 38, No. 187, 1500.41. Test substance was applied on both intact and abraded skin of 6 rabbits for 24 h under occlusive coverage. Signs of irritation were scored at 24 h and 72 h after start of exposure according to Draize criteria.
Results:
No signs of irritation were noted.
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