Registration Dossier

Administrative data

Description of key information

The test substance is considered as not irritating to the skin and eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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
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
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
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.
Interpretation of results:
GHS criteria not met
Conclusions:
All the injections were tolerated without reaction. No signs of irritation were observed after dermal application.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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 tested.
Qualifier:
no guideline followed
Principles of method if other than guideline:
eye irritation study
GLP compliance:
no
Species:
rabbit
Strain:
other: yellow-silver breed
Details on test animals or tissues 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
Vehicle:
other: The pigment was digested in 0.9% NaCl solution tor 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.
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amounts applied: 0.1 mL

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:
one single application
Observation period (in vivo):
The animals were monitored for any signs of irritation 1, 3, 7 and 24 hours after application.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
Irritation parameter:
other: signs of irritation in the ocular mucous membrane
Basis:
mean
Time point:
24 h
Remarks on result:
other: not irritating
Irritant / corrosive response data:
The undiluted filtrate caused no signs of irritation in the ocular mucous membrane.
Interpretation of results:
GHS criteria not met
Conclusions:
The undiluted filtrate caused no signs of irritation in the ocular mucous membrane.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Reliable data from several studies on irritation are available for the test article and for other members of the "perylene based pigments" category (see attached category justification). All of these data are taken into account for the evaluation and assessment of the irritation potential of the test article.

Skin irritation

To test the skin and mucous membrane tolerability the test substance was digested in 0.9% NaCl solution tor 1 hour at 40°C 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. Three rabbits of the yellow-silver breed were used as the experimental animals in each test. The test for skin tolerability was carried out using the Barail test by intracutaneous injection of in each case 0.02 ml of the undiluted filtrate or the filtrate diluted 1:10, 1:100 or 1:1000 into the depilated flank skin. 0.02 ml of 0.9% NaCl solution was injected for control purposes. All the injections were tolerated without reaction. 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. No signs of irritation were observed. Based on these results, the substance was considered to be not irritating (Hoechst AG, 1967).

In several studies performed with other category members the potential to cause skin irritation was found to be very low. None of these studies raised any concerns regarding irritation and therefore none of the substances require classification. All compounds were considered to be not irritating to skin.

Conclusion: Based on the available data for the test substance and taking the data of category members into account, no classification for skin irritation is warranted. The test substance is considered to be not irritating.

Eye irritation

The test article was digested in 0.9% NaCl solution tor 1 hour at 40°C 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. The mucous membrane tolerability was tested by introducing 0.1 ml of the undiluted filtrate once into the conjunctival sac of the rabbit's eye. The animals were monitored tor any signs of irritation 1, 3, 7 and 24 hours after application (Hoechst AG, 1967). No signs of eye irritation were observed. Therefore, the test item was considered to be not irritating to the eyes.

In several studies performed with other category members the potential to cause eye irritation was found to be very low. None of these studies raised any concerns regarding irritation and therefore none of the substances require classification. All compounds were considered to be not irritating to the eye.

Conclusion: Based on the available data for the test substance and taking the data of category members into account, no classification for eye irritation is warranted. The test substance is considered to be not irritating.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for irritation is not warranted under Regulation (EC) No.1272/2008.