Hydrogen [29H,31H-phthalocyaninesulphonato(2-)-N29,N30,N31,N32]cuprate(1-), compound with (Z)-octadec-9-enylamine (1:1)

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:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study.

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, Offenbach/Main, Germany
- Age at study initiation: males: ca. 2.33 kg; females: ca. 2.59 kg
- Housing: 1 animal per cage in stainless steel wire mesh cages
- Acclimation period: at least 8 days before the beginning of the study
- Diet: Kliba Labordiaet 341, 4 mm (Klingentalmuehle AG, Kaiseraugst, Switzerland), ca. 130 g per animal per day
- Water: ca. 250 ml per animal per day
- Clipping of the fur: at least 15 h before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 30-70 %
- Photoperiod: 12 hrs dark / 12 hrs light

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: untreated skin sites of the same animal served as control

Amount / concentration applied:

ca. 0.5 g of a 50 % aqueous suspension of the test material

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2 males and 1 female

Details on study design:

A test patch (2.5 cm x 2.5 cm) is covered with an ca. 0.5 mm layer of the 50 % suspension and applied on the upper third of the back or flanks of the animals.
At the end of the exposure period, the treated sites are washed with lutrol and lutrol/water (1:1).
The readings are made 30-60 min after removal of the patch and 24, 48 and 72 h after beginning of the application.
If there are clinical signs of necroses, these are confirmed by gross-pathological examination after incision of the skin.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Other effects:

No irritation of the skin was observed in all animals at any time point.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

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:

other: well-documented, scientifically acceptable study report. Little information on test item. Only 8 days observation period.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

8-day observation period.

Principles of method if other than guideline:

according to Federal Register 38 , No. 187, § 1500.42, p. 27029 of Sep. 27, 1973 (Draize test)

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

Mean body weight: male 2.32 kg, females 2.47 kg
The animals were offered a standardized animal laboratory diet.

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal

Amount / concentration applied:

77 mg (corresponding to 0.1 ml bulk volume)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

3

Details on study design:

Scoring according to Draize.
The test substance was not washed out.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

1.3

Max. score:

2

Reversibility:

other: reversible in 2/3 animals within 8 days

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0.8

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Redness (score 1) on day 8

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Table 1: Individual results

		cornea	cornea		conjunctivae	conjunctivae	conjunctivae
Time point	Animal no.	opacity	area	iris	redness	chemosis	discharge	remarks
24h	1	2	4	1	2	2	3	E/NA/PV
24h	2	1	4	1	2	2	2	NA
24h	3	1	4	1	2	2	2	NA
48h	1	2	4	1	2	2	3	E/NA/PV
48h	2	1	4	0	2	2	1	NA
48h	3	1	3	1	2	2	1	NA
72h	1	2	2	1	2	2	3	E/NA/PV/J
72h	2	1	2	0	2	2	1	NA/J
72h	3	1	2	1	2	2	1	NA/J
8 days	l	0	0	0	1	0	1	NA
8 days	2	0	0	0	l	0	0	NA/J
8 days	3	1	1	0	1	0	0	NA/J

J = Iris partially coloured

NA = Scar

PV = pupil narrowed

E = pus/sanies

Interpretation of results:

Category 2A (irritating to eyes)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

The substance was tested in rabbits according to a BASF protocol in 1980. The protocol is more stringent than OECD testing guideline 404 but uses a shorter observation period. It shows that the substance is not irritating to rabbit skin. Modern experimental data for structurally related substances confirming absence of a skin irritating potential is used as supporting evidence. Details are shown in the read-across justification attached to the endpoint summary of skin sensitization and genotoxicity.

Eye irritation

The substance was tested in rabbits according to a BASF protocol in 1980. It shows that the substance causes irritating effects on eyes. Effects show a trend toward reversibility, but the effects were not fully reversible within the observation period of 8 days. Mean scores for the values of the first three days are below the threshold for classification and labelling as "highly irritating". Modern experimental data for a structurally related substance confirms that the substance needs to be classified as an eye irritant.

The data matrix and accompanying information is attached to the Endpoint summaries of skin irritation and genotoxicity.

Effects on eye irritation: irritating

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 irritation under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

The criteria for classification as an eye irritant (Xi, R36) are fulfilled.

 

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 irritation under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013. The criteria for classification as irritating to eyes (H319) are fulfilled.