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 50% aqueous substance preparation was tested.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
A 50% aqueous preparation of the substance has been applied on the back and ear of rabbits for 20 hours, observations were reported after 24, 48, 72h and 8 days.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Average weight at study initiation: 2.9 kg
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
50% aqueous preparation
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back of the animals. The skin on the left side of the exposure are was abraded, the right side remained intact.
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
24 h
Remarks on result:
other: could not be scored due to coloration of the skin from the pigment
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
48 h
Remarks on result:
other: 48 h time point not evaluated
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
72 h
Remarks on result:
other: could not be scored due to coloration of the skin from the pigment
Irritation parameter:
erythema score
Remarks:
intact and damaged skin
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
48 h
Remarks on result:
other: 48h time point not evaluated
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
48 h
Remarks on result:
other: 48h time point not evaluated
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test item was found to have no irritation potential, however the erythema reactions could not be scored due to coloring effects of the test substance. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975). Mild edema reactions (score = 1) were reported in all animals at the 24 hours observation time point, abraded skin only. This effect reverted back to normal after 72 hours. On the eighth day the staining effect had cleared; all animals were free of any irritation signs. The test item was found to cause no irritation when applied to intact rabbit skin.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to have no irritation potential, however the erythema reactions could not be scored due to coloring effects of the test substance. Mild edema reactions (score = 1) were reported in all animals at the 24 hours observation time point, abraded skin only. This effect reverted back to normal after 48 hours. On the eighth day the staining effect had cleared; all animals were free of any irritation signs.
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
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: Federal Register 38, No. 187, 1500.42, S. 27019 vom 27.09.73
Principles of method if other than guideline:
The substance is applied in the eye of the rabbit undiluted. Observations are recorded 1 hour, 24 hours, 48 hours, 72 hours after application.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: average weight 3.46 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
undiluted, 100 µl
Duration of treatment / exposure:
one single application without washing was performed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Minimal erythema reactions were reported (maximum score = 1), reversible within 72 hours. One hour after instillation discharge was reported in all animals and in 2/6 rabbits edema formation was observed. These effects were reversible within the first 24 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was concluded not to be irritating to skin.
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

The test substance was applied to the skin of rabbits as a 50% aqueous preparation (amount applied not specified) in an irritation study, comparable to OECD guideline 404 (using 6 animals) and observed for 8 days (BASF, 1978). Application caused no edema to intact skin, but forming of edema (mean score of 1) was observed at the damaged skin after 24 hours which was fully reversible within 72 hours. Determination of erythema was not possible at 24 and 72 hours, due to substance induced coloration of the skin. At day 8 no erythema was observed. The test article was judged to be not irritating to the skin.

In another irritation study comparable to OECD guideline 404, the test article (80% aqueous preparation, amount applied not specified) was applied to the back and ear of two rabbits for 20 hours under occlusive conditions and observed for 8 days (BASF, 1966). Determination of erythema was not possible at 24 hours, due to substance induced coloration of the skin. No effects (erythema and edema) were reported after 8 days. The test item was judged to be not irritating to the skin.

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

100 µl of the test substance was applied to the eyes of 6 rabbits in an eye irritation study comparable to OECD guideline 405 (BASF, 1978). The animals were observed after 24, 48 and 72 hours after the treatment. The cornea, iris and chemosis scores were 0 at time points 24, 48 and 72 hours. The application caused a mean (24, 48 and 72 hours) conjunctivae redness score of 0.4 which was reversible within 72 hours. The test article was determined to be not irritating to the rabbit eye.

In a second irritation study comparable to OECD guideline 405, the test substance (50 µl) was applied to the conjunctival sac of the right eyes of two rabbits (BASF, 1966). The left eyes were treated with talcum powder and served as controls. The substance was not washed out. Animals were observed 1 and 24 hours and after 8 days after the treatment. After 1 and 24 hours remaining substance was observed. The application caused slight redness of the conjunctivae and slight chemosis at 1 hour (scores of 2 for both parameters). Both redness of the conjunctivae and chemosis was fully reversible within 24 hours. The initial irritation response was similar to that caused by the control substance talcum powder. Based on the results of this study, the test substance was considered to be not irritating to the eye.

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.