Registration Dossier
Registration Dossier
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EC number: 944-041-0 | 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Source study has reliability 1. Details on the read across are available in section 13.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG
- Weight at study initiation: mean 2.91 kg (males), 2.59 kg (females)
- Housing: individually in stainless steel cages with wire mesh walk floors, floor area: 40 cm × 51 cm
- Diet: Ovator Solikanin 4 mm, Muskator-Werke, D-4000 Duesseldorf 1, FRG (about 130 g per animal per day)
- Water: tap water (about 250 ml per animal per day )
- Acclimation period: at least 8 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Photoperiod: 12/12 (hrs dark/hrs light)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping of the fur at least 15 hours before the beginning of the study
- Vehicle:
- water
- Controls:
- other: untreated skin site of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mm layer suspension (thus about 0.5 g of the test substance)
- Concentration (if solution): 50% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days
- Number of animals:
- 3 (1 male, 2 females )
- Details on study design:
- TEST SITE
- Area of exposure: third of the back or flank
- Type of wrap if used: test patch (2.5 × 2.5 cm) secured in position with a porous dressing (4 layers of absorbent gauze + porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h
SCORING SYSTEM:
Evaluation of erythema and edema:
0 - none
1 - very slight
2 - well-defined
3 - moderate to severe
4 - severe
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Animal 1: male, 2.91 kg
Animal 2: female, 2.69 kg
Animal 3: female, 2.49 kg
Readings:
| Readings | Animal | Erythema | Edema |
| 4 h | 1 | 1 | 0 |
| 2 | 1 | 0 | |
| 3 | 1 | 0 | |
| 24 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 1 | 0 | |
| 48 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| 72 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| 8 d | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| mean 24 - 72 h | 1 | 0.0 | 0.0 |
| 2 | 0.0 | 0.0 | |
| 3 | 0.3 | 0.0 | |
| mean 24 - 72 h | 0.1 | 0.0 | |
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 of the substance was assessed according to OECD guideline 404. Test substance was applied to the skin of 3 rabbits, under semiocclusive coverage for 4 h. Signs of irritation in terms of erythema and oedema were recorded.
Results:
No signs of oedema were noted; slight signs of erythema were seen in 1/3 rabbits, which were reversible within 48 hours.
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