[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper tris(dodecylbenzenesulphonate)

Endpoint summary

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:

other: Comparable to guideline study with acceptable restrictions (

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(no data on test substance purity, exposure period 20 h with occlusive dressing, 2 animals, no 72 h score, 50% test substance solution)

Principles of method if other than guideline:

BASF-test:
The test substance was applied to a 2.5 x 2.5 cm application site of white Vienna rabbits for 20 h under occlusive conditions. Additionally, the substance was applied for 1, 5 and 15 minutes. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24, 48 hours, 5, 7 and 8 days after administration. Findings were graded as described in OECD test guideline 404.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.99 kg and 3.08 kg (males)
- Diet: ad libitum
- Water: ad libitum

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: untreated skin of same animal

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): 50 % (in water)

Duration of treatment / exposure:

The test substance was applied for 1 min, 5 min, 15 min (short term) and 20 hours (long term).

Observation period:

8 days

Number of animals:

2 rabbits

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lutrol / lutrol 50% in water
- Time after start of exposure: 1 min, 5 min, 15 min, 20 hours

SCORING SYSTEM: as described in OECD guideline 404 (the BASF-code from the raw data was converted into the OECD Draize scheme).

Irritation parameter:

edema score

Basis:

mean

Remarks:

(animals 1-2)

Time point:

other: 24-48 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

other: 20 h administration

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(animals 1-2)

Time point:

other: 24 - 48 h

Score:

0.75

Max. score:

4

Reversibility:

fully reversible within: 48 h and 5 days

Remarks on result:

other: 20 h administration; see table below for details

Irritant / corrosive response data:

The short exposure periods (1, 5 and 15 min) showed no corrosive potential of the test substance.

Other effects:

Blue substance remnants (until the end of the observation period) infered with the evaluation of erythema

Exposition:	20 h
Animal	Reading	Erythema	Edema	Comment
1	24 h	1	0	blue substance remnants
2	24 h	1	0	blue substance remnants
1	48 h	0	0	blue substance remnants; decreased food consumption
2	48 h	1	0	blotchy, blue substance remnants
1	5 d	0	0	substance remnants
2	5 d	0	0	substance remnants
1	7 d	0	0	substance remnants
2	7 d	0	0	substance remnants
1	8 d	0	0	substance remnants
2	8 d	0	0	substance remnants
mean	24 - 48 h	0.75	0.00
Exposition:	15 min
Animal	Reading	Erythema	Edema	Comment
1	15 min	2	0	blotchy, blue substance remnants
2	15 min	2	0	blue substance remnants
1	24 h	0	0	substance remnants
2	24 h	1	0	blotchy, blue substance remnants
1	48 h	0	0	substance remnants
2	48 h	0	0	substance remnants
1	5 d	0	0	substance remnants
2	5 d	0	0	substance remnants
1	7 d	0	0	substance remnants
2	7 d	0	0	substance remnants
1	8 d	0	0	substance remnants
2	8 d	0	0	substance remnants
mean	24 - 48 h	0.25	0.00
Exposition:	5 min
Animal	Reading	Erythema	Edema	Comment
1	5 min	1	0	blotchy, substance remnants
2	5 min	2	0	blotchy, substance remnants
1	24 h	0	0	substance remnants
2	24 h	0	0	blue substance remnants
1	48 h	0	0	substance remnants
2	48 h	0	0	substance remnants
1	5 d	0	0	substance remnants
2	5 d	0	0	substance remnants
1	7 d	0	0	substance remnants
2	7 d	0	0	substance remnants
1	8 d	0	0	substance remnants
2	8 d	0	0	substance remnants
mean	24 - 48 h	0.00	0.00
Exposition:	1 min
Animal	Reading	Erythema	Edema	Comment
1	1 min	2	0	blotchy, blue substance remnants
2	1 min	0	0	blue substance remnants
1	24 h	0	0	blue substance remnants
2	24 h	0	0	blue substance remnants
1	48 h	0	0	substance remnants
2	48 h	0	0	substance remnants
1	5 d	0	0	substance remnants
2	5 d	0	0	substance remnants
1	7 d	0	0	substance remnants
2	7 d	0	0	substance remnants
1	8 d	0	0	substance remnants
2	8 d	0	0
mean	24 - 48 h	0.00	0.00

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In the key skin irritation study (BASF AG, 1976) two rabbits were treated once with the test item via occlusive dermal exposure for up to 20 h. After exposure animals were observed for 8 days. Skin reactions were observed and scored according to the BASF scoring system which was converted into Draize Scores. Thereby animals showed an average erythema scores of 0.5 and 1.0 (24h and 48h), which were fully reversed within the observation period. The edema score was 0 for both animals. In conclusion, no other irritating effects were observed and thus the test item was classified as not irritating to skin.

Eye irritation

In vivo

In an eye irritation study (BASF AG, 1976, equivalent to OECD 405) two Vienna White rabbits were treated once with 50 mg of the test item by single exposure without washing of the eyes. The second eye of each animal was treated with talcum. Eye reactions were observed and scored according to Draize 10 min, 1h, 3h, 24h, 48h and 5, 7 and 8 days after the start of treatment. The scoring system was adapted to Draize scoring. Both animals showed a mean cornea score of 1, which was not reversible within the observation period. The animals showed a mean conjunctivae score of 1 and 2 (24h and 48h), which was fully reversible within 8 days. The chemosis score was determined to be 0 and 0.5 (24h and 48h), which was fully reversible within 48h. All other irritation parameters showed a score of 0. In conclusion, the test item was irritating to the eyes under the conditions of the study. The study is inconclusive in regard to classification and labelling since the observation time points and the number of animals is insufficient. Therefore, further in-vitro testing was performed.

In vitro

The potential of the test item to cause serious damage to the eyes was assessed by a single topical application of 750 mg of a 20% test substance preparation to the epithelial surface of isolated bovine corneas (BCOP Assay). The study followed the OECD testing guideline 437 and the principles of GLP (BASF SE, 2011). Three corneas were treated with the test substance preparation for an exposure period of 4 hours. Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passed across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score (IVS) of the test substance relative to the control corneas. Application of 750 μL of 20% (w/v) solution of Imidazole in highly de-ionized water served as positive control. The in vitro irritancy scores were 3.9 for the negative control, 1.5 for the test item and 214 for the positive control. Therefore, the substance was considered to be not highly irritating to eyes.

As the BCOP assay can only identify highly irritating substances, a recently validated in-vitro study for the endpoint "irritation" was performed (BASF SE, 2011). The potential to cause ocular irritation was assessed by a single topical application of 50 μL bulk volume (about 18 mg) of the test substance to a reconstructed three dimensional human cornea model (EpiOcular™ Assay). Two EpiOcular™ tissue samples were incubated with the test substance for 90 minutes followed by a 18-hour post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues was compared to that of negative control tissues. The quotient of the values indicated the relative tissue viability. Due to the color of the test substance it could not be determined whether the test substance was able to reduce MTT directly. Therefore an additional MTT reduction control was introduced. The result of the KC did not indicate an increased MTT reduction. The mean viability of the test-substance treated tissues was 116%. Based on the results and applying the evaluation criteria it was concluded, that the substance did not show an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.

Overall, the substance is considered to be non irritating to eyes.

Justification for selection of skin irritation / corrosion endpoint:
most reliable study

Justification for selection of eye irritation endpoint:
all studies relevant

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin or eye irritation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

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. 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 third time in Directive EC 618/2012.