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Administrative data

Description of key information

Skin irritation/corrosion: non-irritating, according OECD TG 404, GLP-compliant, 0.5 g test substance, semiocclusive, 4 h, rabbit, 2005, K1
Eye Irritation: non-irritating, according OECD TG 405, GLP-compliant, 0.1 g test substance, 24 h, rabbit, 2005, K1

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
Study period:
12-OCT-2005 - 01-NOV-2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Physical state: Solid, black powder
- Analytical purity: > 99%
- Storage condition of test material: Room temperature
- Expiration date of the lot/batch: 18 November 2020
- CAS No. Cis: 55034-81-6 Trans: 55034-79-2
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kisslegg/Germany
- Age at study initiation: 10 to 11 weeks (male), 11 to 12 weeks (females)
- Weight at study initiation: 2097 g (male), 1991 and 1948 g (female)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 43/05) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): automatically controlled light cycle of 12 hours light and 12 hours dark.
- Music was played during the daytime light period.
Type of coverage:
semiocclusive
Preparation of test site:
other: Four days before treatment, the left flank was clipped with an electric clipper
Vehicle:
other: moistened with approximately 0.5 mL of purified water before application
Controls:
other: untreated skin of the same animals served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g was moistened with approximately 0.5 mL of purified water before application.

Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Four days before treatment, the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm² (10 cm x 10 cm) . The skin of the animals was examined one day before treatment, and regrown fur of all animals was clipped again. Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test.
- Area of exposure: The test item was placed on a surgical gauze patch (ca. 4 cm x 4 cm). This gauze patch was applied to the intact skin of the clipped area.
- Type of wrap if used: The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site.
- Time after start of exposure: 4 h

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004

OTHER
- As it was suspected that the test item might produce irritancy, a single animal (one female) was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 4-hour exposure, the test was completed using the two remaining animals for an exposure period of four hours.
- No necropsy was performed on the animals sacrificed at termination of observation.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no abnormal findings noted
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no abnormal findings noted
Irritant / corrosive response data:
Signs such as erythema and oedema could not be evaluated in all animals at the 1-hour reading due to presence of test item remnants and staining at the application site. Where evaluation was permitted, the test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

The test item caused a slight to marked black staining at the test site of all animals from the 1- to the 48-hour reading after treatment and persisted as slight staining in two animals until the 72-hour and 10-day examination, respectively.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
The body weights of all rabbits were considered to be within the normal range of variability.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions chosen and based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), the test article is considered to be "not irritating" to rabbit skin.
Executive summary:

The primary skin irritation potential of the test article was investigated in a GLP compliant study according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. Signs such as erythema and oedema could not be evaluated in all animals at the 1-hour reading due to presence of test item remnants and staining at the application site. Where evaluation was permitted, the test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. The application of the test article to the skin did however cause a slight to marked black staining at the test site of all animals from the 1- to the 48 -hour reading and persisted as slight staining in two animals until the 72-hour and 10-day examination, respectively, but had disappeared after 14 days. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant irreversible damage to the 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
Study period:
26-OCT-2005 - 04-NOV-2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Physical state: Solid, black powder
- Analytical purity: > 99%
- Storage condition of test material: Room temperature
- Expiration date of the lot/batch: 18 November 2020
- CAS No. Cis: 55034-81-6 Trans: 55034-79-2
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kisslegg/Germany
- Age at study initiation: 11 to 12 weeks (male), 12 to 14 weeks (females)
- Weight at study initiation: 2085, 2725, 2667 g.
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet : Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 43/05) provided by Provimi Kliba AG, Kaiseraugst.
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): approximately 10-15 air changes per hour.
- Photoperiod (hrs dark / hrs light): automatically controlled light cycle of 12 hours light and 12 hours dark.
- Music was played during the daytime light period.
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the reference control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g (per animal) was weighed and applied undiluted

Duration of treatment / exposure:
24 h
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
PREPARATION AND TREATMENT
- The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.

- On the day of treatment, 0.1 g of test material was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. As it was suspected that the test item might produce irritancy, a single animal (one female) was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 1- and 24-hour examinations, the test was completed using the two remaining animals.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes were rinsed 24 hours after instillation with physiological saline (0.9 % NaCl).
- Time after start of exposure: 24 h

SCORING SYSTEM:
The ocular reaction (i.e. corneal opacity, iridic effects, conjunctivae and chemosis) was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004, at approximately 1, 24, 48 and 72 hours after instillation.

TOOL USED TO ASSESS SCORE: a Varta Cliptrix diagnostic-lamp.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no abnormalities observed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: No abnormalities observed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no abnormalities observed.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.56
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity, iris and chemosis were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.67, 0.33 and 0.67 for reddening for all three animals.
 
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement interval. Slight to moderate reddening of the conjunctivae was noted in all animals at the 1-hour reading and persisted as slight reddening in one animal up to the 24-hour reading and in two animals until the 48-hour examination. Slight swelling (chemosis) of the conjunctivae was observed in one animal at the 1-hour reading.
 
Slight to moderate reddening of the sclerae was present in two animals at the 1-hour reading and persisted as slight reddening up to the 24- or 48-hour examination, respectively. Slight ocular discharge was noted in two animals at the 1-hour reading. No abnormal findings were observed in the treated eye of any animal 72 hours after treatment, the end of the observation period for all animals.
 
No staining of the treated eyes produced by the test item was observed. Slight black remnants of the test item were observed in the eye or conjunctival sac of two animals at the 1-hour reading.
 
No corrosion of the cornea was observed at any of the reading times.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions chosem and based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001), the test article is considered to be "not irritating" to the rabbit eye.
Executive summary:

The primary eye irritation potential of the test article was investigated in a GLP compliant study according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.67, 0.33 and 0.67 for reddening and 0.00 for chemosis for all three animals, respectively. The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 72 hours after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. Slight black remnants of the test item were observed in the eye or conjunctival sac of two animals at the 1-hour reading. No staining of the treated eyes by the test item was observed and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation


In a primary skin irritation study the test item was investigated according to OECD test guideline 404 (RCC, 2005). The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. Signs such as erythema and oedema could not be evaluated in all animals at the 1-hour reading due to presence of test item remnants and staining at the application site. Where evaluation was possible, the test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was 0. The application of the test item to the skin did however cause a slight to marked black staining at the test site of all animals from the 1- to the 48-hour reading and persisted as slight staining in two animals until the 72-hour and 10-day examination, respectively, but had disappeared after 14 days. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Under the test conditions chosen, the test item did not induce significant irreversible damage to the skin and is considered to be not irritating to rabbit skin.


 


Eye irritation


The primary eye irritation potential of the test article was investigated according to OECD test guideline no. 405 (RCC, 2005). The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0 .67, 0.33 and 0.67 for reddening and 0.00 for chemosis for all three animals, respectively. The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 72 hours after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. Slight black remnants of the test item were observed in the eye or conjunctival sac of two animals at the 1-hour reading. No staining of the treated eyes by the test item was observed and no clinical signs were observed. The test item did not induce significant or irreversible damage to the eye under the test conditions chosen and is considered to be not irritating to the rabbit eye.


 


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. Studies concerning the irritating potential for skin and eyes are available for all category members. In no study evidence for irritating or corrosive effects of the substances was observed. The category members can therefore all considered as not irritating to the skin and eyes.

Justification for classification or non-classification

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


The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. A GLP-compliant OECD 404 study is available for skin irritation. A GLP-compliant OECD 405 study is available for eye irritation. In both studies, the scores for the test item treated tissues were below the thresholds for classification as an irritant. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.