[1,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper

Skin irritation / corrosion

Administrative data

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 OECD 404 guideline study (1992) with acceptable deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

; [application time: 1, 5, 15 min and 20 h (OECD: 4 h); 4 animals used (OECD: 3); observation period 8 days (OECD: 14); skin changes recorded on working days; dose ~1 ml (OECD: 0.5 ml), additionally testing of the ear (not recomm. by the OECD guideline]

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper

EC Number:

205-685-1

EC Name:

29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper

Cas Number:

147-14-8

Molecular formula:

C32H16CuN8

IUPAC Name:

[29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breed of Medical-Biological Reseach Laboratories of BASF
- Average weight at study initiation: ca. 2.75 kg
- Diet: Altromin-MS (Altrogge, Lage/L. Germany), ad libitum
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

The test substance, moistured with water and mixed to a paste (concentration: 50 %), was applied to a 2.5 cm x 2.5 cm patch (~1 ml)

Duration of treatment / exposure:

20 hours

Observation period:

The animals were observed following exposure for 8 days on working days. Skin changes were recorded after removal of the bandage after 1 hour as well as after 24 h, 48 h, and on day 6 and 8.

Number of animals:

4 animals, 2 males and 2 females

Details on study design:

The test substance, moistured with water and mixed to a paste, was applied to a 2.5 cm x 2.5 cm patch (~1 ml) and placed on the clipped and intact skin of four white Vienna rabbits for 1 min, 5 min, 15 min and 20 h under occlusive conditions. The test substance was removed by washing once with 50 % Lutrol. Skin reactions were recorded after 1 h, 24 h, 48 h, and on day 6 and 8. The application time used for assessment was 20 hours, the test material was applied on dorsal skin. The corresponding reading time points used for assessment were 24 and 48 hours after application. Dermal reactions were classified using a BASF-scoring system, which is convertible into the current OECD Draize scheme. For the evaluation, the BASF scores given in the raw data were converted to Draize scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all animals

Time point:

other: 24-48 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all animals

Time point:

other: 24-48 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No formation of erythema or edema were observed (Draize score = 0) at any reading time point and after any application time.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information