Brominated chlorinated copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, wherein the number of bromines is equal to or more than 10 and less than 16, and the number of chlorines is equal to or more than 0 and less than 7

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:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: US Federal Register 38 No 187 § 1500.41

Version / remarks:

24h occlusive exposure, investigation of hypoderm and underlying muscles

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

green powder

Specific details on test material used for the study:

Heliogengrün 9140

Test animals

Species:

rabbit

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 3-4kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least three days

ENVIRONMENTAL CON DITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 34 - 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

intact and scarified sites were tested on the same animal

Vehicle:

other: 50% Lutrol 400 (= PEG 400) in water

Remarks:

for moistioning

Controls:

other: yes, untreated skin sites

Amount / concentration applied:

0.5g per site (1g per animal)

Duration of treatment / exposure:

24h

Observation period:

7 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 6.25cm2
- Type of wrap if used: PVC foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm vehicle
- Time after start of exposure:24h

OBSERVATION TIME POINTS
24h and 72h for skin findings, 7 days for hypoderm and muscle

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable, since no findings

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable, since there were no findings

Results 3

Irritation parameter:

erythema score

Basis:

other: all animals

Time point:

24 h

Remarks on result:

not determinable

Remarks:

The green test material had stained the skin.

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable, since no findings

Remarks on result:

other: For half of the animals, green staining of the skin interfered with scoring.

Irritant / corrosive response data:

At the end of treatment (24h reading), scoring for erythema was not possible as the green test item had stained the skin.
At the 72h reading, scoring was still not possible for 3 animals. For the other 3 animals, no erythema (score = 0) was observed. Findings were equal for intact and scarified skin.

Edema was not observed in any animal at any time point (Score = 0).

Other effects:

There were no adverse findings on the hypoderm and muscles underlying the treated skin sites.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met