Registration Dossier
Registration Dossier
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EC number: 941-788-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Calcination product of titanium dioxide, tin monoxide, zinc oxide and dihydrogen wolframate
- EC Number:
- 941-788-4
- Molecular formula:
- Ti 1 Sn 0,6 Zn 0,5 W 0,15 O 4
- IUPAC Name:
- Calcination product of titanium dioxide, tin monoxide, zinc oxide and dihydrogen wolframate
- Test material form:
- solid: particulate/powder
- Details on test material:
- > 98 g/100 g
Physical state / color: Solid / red
Storage conditions Room temperature, store dry
Constituent 1
- Specific details on test material used for the study:
- Red solid
expiry date of sample: 2025
The test item was homogeneous by visual inspection.
Storage at room temperature
pH-value: approx. 8 (moistened with water)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS GmbH, Germany
- Age at study initiation: 4 - 8 months
- Weight at study initiation: 3.25 kg – 4.17 kg
- Housing: Single cages
- Diet ad libitum
- Water ad libitum
- Acclimation period: Acclimatization for at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
IN-LIFE DATES: From: 6 June 2017 To: 10 July 2017
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- single treatment
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- The cutaneous reactions were assessed immediately after removal of the patch,
approximately 1, 24, 48 and 72 hours after removal of the patch and in weekly intervals
until day 14.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: no indication of edema at any observation time point
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- other: fully reversible within 7 and 14 days in two animals, not fully reversed after 14 days in one animal
Any other information on results incl. tables
| Animal No. : | 1 | ||
| Exposure periode: | 4h | ||
| Readings | Erythema | Edema | Additional Findings |
| 0h | * | 0 | *Test item residues; no erythema could be determined |
| 1h | * | 0 | *Test item residues; no erythema could be determined |
| 24h | 2 | 0 | - |
| 48h | 2 | 0 | - |
| 72h | 2 | 0 | - |
| 7d | 2 | 0 | - |
| 14d | 0 | 0 | SD |
| Mean 24h - 72h |
2.0 | 0.0 | |
| Animal No. : | 2 | ||
| Exposure periode: | 4h | ||
| Readings | Erythema | Edema | Additional Findings |
| 0h | * | 0 | *Test item residues; no erythema could be determined |
| 1h | * | 0 | *Test item residues; no erythema could be determined |
| 24h | * | 0 | *Test item residues; no erythema could be determined |
| 48h | 1 | 0 | - |
| 72h | 1 | 0 | - |
| 7d | 0 | 0 | SD |
| 14d | |||
| Mean 24h - 72h |
1.0 | 0.0 | |
| Animal No. : | 3 | ||
| Exposure periode: | 4h | ||
| Readings | Erythema | Edema | Additional Findings |
| 0h | * | 0 | *Test item residues; no erythema could be determined |
| 1h | * | 0 | *Test item residues; no erythema could be determined |
| 24h | 2 | 0 | *Test item residues |
| 48h | 2 | 0 | - |
| 72h | 2 | 0 | - |
| 7d | 1 | 0 | - |
| 14d | 1 | 0 | - |
| Mean 24h - 72h |
2.0 | 0.0 | |
| Mean Erythema 24h - 72h |
Mean Edema 24h - 72h |
|
| Animal No. 1 | 2.0 | 0.0 |
| Animal No. 2 | 1.0 | 0.0 |
| Animal No. 3 | 2.0 | 0.0 |
| Mean of 3 Animals |
1.7 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
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