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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 preparation was tested
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main, FRG
- Housing: Stainless steel with wire mesh walk floor, floor area: 40 cm x 51 cm
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm; Muskator-Werke, D-4000 Düsseldorf 1, FRG (about 130 g per animal daily)
- Water (e.g. ad libitum): 250 ml tap water per animal daily
- Acclimation period: At least approx. 8 days in the skin laboratory before the beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% aqueous preparation
Application volume: Wetting of the test patch with a layer of approx. 0.5 mm of the 50% preparation (the test patch measures 2.5 x 2.5 cm and thus about 0.5 g is applied; due to the natural moisture of the skin, distilled water is used for preparing the preparations in order to carry out the test under conditions am physiological as possible.
Duration of treatment / exposure:
4 hours
Observation period:
30 - 60 minutes after removal of the test patches and 24 hours, 48 hours, 72 hours and 8 days after the beginning of application
Number of animals:
2 females, 1 male
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: Scale for scoring of erythema and edema:
0 = None
1 = Very slight
2 = Well-defined
3 = Moderate to severe
4 = Severe to very severe
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
After 4 hours, erythema score 2 (extending beyond the area of exposure) was observed in all animals; edema score 1 was observed in one animal; edema extending beyond the area of exposure in one animal.
After 24 hours, erythema extending beyond the area of exposure (score 1 in two animals and score 2 in one animal). In two animals, the erythema persisted at score 1 until the 72 h time point. reversibvle within 8 days.
Other effects:
No abnormalities identified at necropsy.

Overview on results:

Animal 1 Animal 2 Animal 3
erythema 4 h 2 2 2
24 h 2 1 1
48 h 1 1 0
72 h 1 1 0
8 d 0 0 0
edema 4 h 0 0 1
24 h 0 0 0
48 h 0 0 0
72 h 0 0 0
8 d 0 0 0
Interpretation of results:
GHS criteria not met
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:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main, FRG
- Weight at study initiation: 2.79, 2,89 and 2.93 kg (individual weights)
- Housing: Stainless steel with wire mesh walk floor, floor area: 40 cm x 51 cm
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm; Muskator-Werke D-4000 Düsseldorf 1, FRG (about 130 g per animal daily)
- Water (e.g. ad libitum): About 250 ml tap water per animal, daily
- Acclimation period: At least approx. 8 days in the skin laboratory before the beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully airconditioned room
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (ca. 28 mg)
Duration of treatment / exposure:
one single application, no washing was performed
Observation period (in vivo):
1 h, 24 h, 48 h, 72 h, 8 d after application
Number of animals or in vitro replicates:
2 females, 1male
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:
other: 1 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
not fully reversible within: 8 days (one animal had a conjunctivae score of 1 after 8 days)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
The ocular reactions observed were below the regulatory threshold. The remaining redness at the end of observation in one animal is expected to resolve eventually.

Overview of results:

Animal 1 Animal 2 Animal 3
cornea 1 h 0 0 0
24 h 0 0 0
48 h 0 0 0
72 h 0 0 0
8 d 0 0 0
redness 1 h 2 2 2
24 h 2 2 2
48 h 1 1 1
72 h 1 1 1
8 d 1 0 0
chemosis 1 h 1 1 1
24 h 1 1 1
48 h 0 0 0
72 h 0 0 0
8 d 0 0 0
Iris 1 h 0 0 0
24 h 0 0 0
48 h 0 0 0
72 h 0 0 0
8 d 0 0 0
Interpretation of results:
GHS criteria not met
Conclusions:
In the study presented, the eye irritating potential of the test substance was investigated. One animal showed a conjunctivae score of 1 after 8 days. However, the ocular reactions observed were below the regulatory threshold and thus, the test substance was concluded not to be irritating to the eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

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 following OECD guideline 404, 500 mg of a 50% aequous preparation of the test substance was applied to the left flanks of three Vienna White rabbits. The untreated right flan served as control. The animals were observed for 8 days (BASF AG, 1982). An edema extending beyond the area of exposure with a score of 1 was observed in one animal after 4 hours, reversible within 24 hours. In addition, erythema formation (score = 2) was observed in all animals 4 hours after exposure. The erythema extended beyond the area of exposure in all animals at this observation time point. The severity of erythemas decreased during the observation period and was fully reversible in all animals within 8 days. The mean (24, 48, 72 hours) erythema and edema scores were 0.9 and 0, respectively. Based on the results of this study, the test article caused a mild irritation response below the level of regulatory significance and is therefore considered to be not irritating to the rabbit 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 following OECD guideline 405, 0.1 ml of the test substance was applied undiluted into the eyes of three Vienna White rabbits (BASF AG, 1982). The test animals were observed for eight days and irritation scores were recorded 1, 24, 48 and 72 hours and 8 days after the instillation. No effects in the cornea and iris were observed at any observation time point. The mean scores (24, 48, 72 hours) for conjunctival redness and chemosis were 1.3 and 0.3, respectively. One animal displayed a conjunctival redness of at the end of the observation period with a score of 1 (full reversibility is expected after longer observation). Chemosis was fully reversible within 48 hours. Based on the results of this study, the test article caused mild ocular reactions below the level of significance and is therefore regarded as not irritating to the rabbit 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.

 

Based on the available data, the substance does need not to be classified for eye irritation according to Directive 67/548/EEC and according EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.