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)
GLP compliance:
no
Species:
rabbit
Strain:
other: Weißer Wiener
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: average weight 3.0 kg
Type of coverage:
occlusive
Preparation of test site:
other: intact and damaged skin
Vehicle:
water
Controls:
no
Amount / concentration applied:
The test substance was given as a 50% aqueous preparation. The amount applied is not specified.
Duration of treatment / exposure:
not specified
Observation period:
8 days
Number of animals:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: on the first day after instillation
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
other: Determination of erythema was not possible at 24 and 72 hours.
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
damaged skin
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
other: Determination of erythema was not possible at 24 and 72 hours.
Irritation parameter:
edema score
Remarks:
damaged skin
Basis:
mean
Time point:
24/48/72 h
Score:
0.55
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
The test item was found to have no irritation potential, however the exact determination of erythema scores at 24, 48 and 72 hours (except animal #1 intact skin) was not possible due to coloring by 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). 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 substance did not induce adverse effects to the skin and thus, was found to be not irritating to skin.
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)
GLP compliance:
no
Species:
rabbit
Strain:
other: Weißer Wiener
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: average weight 2.8 kg
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
The substance was applied undiluted
- Amount(s) applied (volume or weight with unit): 100 µl test material
Duration of treatment / exposure:
single application, no washing was performed
Observation period (in vivo):
24 hours, 48 hours and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
TOOL USED TO ASSESS SCORE: fluorescein (last observation day)
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:
0.8
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 redness of the conjunctivae observed in 2/3 animals, reversible after 72 hours. One animal still showed redness on day 3 (the last day of observation), which is expected to be reversible upon longer observation.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was found to be not irritating to eyes.
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

In a skin irritation study similar to OECD guideline 404, the test substance was applied to the skin of 3 rabbits as a 50% aqueous preparation (amount applied not specified) and observed for 8 days (BASF AG, 1978). Application caused no edema to intact skin, but formation of edema (in one animal a score of 1 and in one animal a score of 2) was observed when applied to damaged skin 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 substance was judged to be not irritating to the skin.

In a second skin irritation study comparable to OECD guideline 404, 50 µl of the test substance (50% aqueous preparation) was applied to the skin of rabbits for 20 hours (using 2 animals) under occlusive conditions and observed for 8 days (BASF AG, 1976). Determination of erythema was not possible at 24 hours, due to substance induced purple coloration of the skin. No effects (erythema and edema) were reported after 8 days. The test substance was therefore regarded as 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

In an eye irritation study similar to OECD guideline 405 (BASG, 1978), 100 µl of the test article was applied to the eyes of three rabbits. Animals were observed after 24, 48 and 72 hours and 8 days 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 0.8 which decreased from day 3 onwards. As a result, the test item was considered to be not irritating to the eye.

In a second eye irritation study (BASF, 1976), 50 µl of the test article was instilled into the conjunctival sac of one eye in a total of two animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account. The substance caused mild reactions of the conjunctiva, the mean irritation scores (24 and 72 h) for chemosis and redness were 0.25 and 1, respectively. These effects were reversible within 7 days, except for the redness in one animal (reversibility is expected after longer observation). The irritation observed caused by the test substance was not clearly different from the control substance talcum powder. The assessment of the substance based on the results of this study is not irritating.

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.