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Toxicological information

Skin irritation / corrosion

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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:
2017
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

Constituent 1
Reference substance name:
Calcination products 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 products 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
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