Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Only a filtrate was used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test for skin tolerability was carried out using the Barail test by intracutaneous injection. In a further test the undiluted aqueous filtrate was applied 5 times in 5 days in a quantity of 0.5 ml each time to the depilated and intact flank skin of rabbits.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals

Species:
rabbit
Strain:
other: yellow-silver breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: animals were kept in individual cages
- Diet (e.g. ad libitum): ALTROMIN K, manufactured by Altromin GmbH in Lage/Lippe
- Water (e.g. ad libitum): tap water

Test system

Type of coverage:
occlusive
Preparation of test site:
other: depilated and intact skin
Vehicle:
other: The pigment was digested in 0.9% NaCl solution tor 1 hour at 40 ºC in a heating cabinet. The solution was then filtered off and the aqueous filtrate obtained.
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amounts applied: 0.5 mL
- Concentration applied: 2.5 g in 25 mL NaCl solution.

VEHICLE
- Concentration (if solution): pigment was digested in 0.9% NaCl solution for 1 hour at 40 ºC in a heating cabinet, the amount being 2.5 g in 25 ml NaCl solution. The solution was then filtered off and the aqueous filtrate obtained.
Duration of treatment / exposure:
applied 5 times in 5 days
Observation period:
No data
Number of animals:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: not specified
Remarks on result:
other: not irritating
Irritation parameter:
edema score
Basis:
mean
Time point:
other: not specified
Remarks on result:
other: not irritating
Irritant / corrosive response data:
All the injections were tolerated without reaction. No signs of irritation were observed after dermal application.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
All the injections were tolerated without reaction. No signs of irritation were observed after dermal application.