Reaction product of Chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]aluminium, sulphuric acid and caustic soda

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

An acute dermal toxicity study was conducted with the test substance on 5 male and 5 female rats with an exposure period of 24 hours and an observation period of 14 days.

GLP compliance:

no

Remarks:

Study pre-dates GLP regulations

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

EC Number:

307-259-1

EC Name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

Cas Number:

97592-62-6

Molecular formula:

not available

IUPAC Name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

Test material form:

solid

Specific details on test material used for the study:

- Test substance name as used in the study report: FAT 60149/B.

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: Mean group body weight Males 212-218 g; Females: 182-204 g
- Housing: Individually in Macrolon cages (type 2)
- Diet: ad libitum rat food - NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10

Administration / exposure

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

Approximately 24 hours before treatment an area on the back of the rats of approximately 60 square cm was shaved with an electric clipper. For treatment the test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised.

Duration of exposure:

24 hours

Doses:

2000, 2500, 3000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 2, 3, 5, 24 hours after administration, then daily
- Frequency of weighing: before administration, at 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: histopathology

Statistics:

LD50 including 95 % confidence limits are calculated by the logit model.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortallity occurred at the tested concentrations.

Clinical signs:

other: - Controls: no clinical symptoms - 2000 mg/kg bw: dyspnoea, exophthalmos, ruffled fur, curved body position. No symptoms after day 7. - 2500 mg/kg bw: same symptoms as above. - 3000 mg/kg bw: same symptoms as above.

Gross pathology:

At autopsy of treated and control rats no gross pathological changes were seen. At the site of the dermal treatment neither macroscopical nor histopathological findings which could be related to the dermal application of the substance were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met