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

Repeated dose toxicity: dermal

Administrative data

Endpoint:

repeated dose toxicity: dermal, other

Remarks:

Two months skin depigmentation study

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

5 male and 5 female black Guinea Pigs were tested according to the proposed model of Gellin et al, 1979. (G.A. Gellin, H.I. Maibach, M.H. Misiaszek, M. Ring: Detection of environmental depigmenting substances. Cont. Dermatitis 5, 201-213, 1979.). Animals were treated 5 times a week for 2 months (9 weeks).

GLP compliance:

no

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:

- Name used in the study report: FAT 60'149/B

Test animals

Species:

guinea pig

Strain:

other: black, outbred strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ivanovas
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 270-370 g.
- Housing: individually in Macrolon cages (type 3)
- Diet: ad libitum standard guinea pig pellets - NAFAG No. 830, Gossau SG supplemented with fresh carrots
- Water: ad libitum
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Type of coverage:

open

Vehicle:

other: 80% DAE433 / 20% physiological saline

Remarks:

DAE433 = 40% dimethylacetamide, 30% acetone, 30% ethanol

Details on exposure:

TEST SITE
- Area of exposure: flanks
- % coverage: 2 x 2 cm
- Type of wrap if used: none

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 0%, 0.01%, 0.1%, 0.3%

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

5 times a week for 2 months (9 weeks)

Frequency of treatment:

5 times a week

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0.01 other: %

Doses / concentrations 2

Dose / conc.:

0.1 other: %

Doses / concentrations 3

Dose / conc.:

0.3 other: %

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Positive control:

10 % monomethyl ether of hydroquinone; 1 % tertiary butyl catechol

Examinations

Observations and examinations performed and frequency:

At the end of every week the reaction sites were evaluated according to the scoring scale of Gellin et al.

Results and discussion

Results of examinations

Clinical signs:

not examined

Dermal irritation:

not examined

Mortality:

no mortality observed

Body weight and weight changes:

not examined

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Immunological findings:

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

not examined

Neuropathological findings:

not examined

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Other effects:

no effects observed

Description (incidence and severity):

Test group:
- vehicle control: 10/10 score 0 (no visible depigmentation)
- 0.01% substance: 10/10 score 0
- 0.1% substance: 10/10 score 0
- 0.3% substance: 10/10 score 0
- 10 % monomethyl ether of hydroquinone: 1/10 score +-, 4/10 score + (uniform hypopigmentation), 5/10 score ++ (complete depigmentation)
- 1 % tertiary butyl catechol: 1/10 score 0, 5/10 score +, 4/10 score ++
Conclusion: the test substance did not show depigmenting effects.