reaction mass of: pentasodium bis[6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III);tetrasodium [6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato][6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III);trisodium bis[6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III)

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

444-290-0

EC Name:

-

Cas Number:

508202-43-5

Molecular formula:

Not applicable

IUPAC Name:

tricobalt(3+) dodecasodium tris(2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-6-(phenylamino)-3-sulfonatonaphthalen-1-olate) tris(2-[2-(2-oxido-5-sulfonatophenyl)diazen-1-yl]-6-(phenylamino)-3-sulfonatonaphthalen-1-olate)

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HanBrl

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: RCC Ltd, Biotechnology and Animal Breeding Division CH-4414 Füllinsdorf / Switzerland
-Age at study initiation:
♂ 9 weeks
♀ 13 weeks
-Weight at study initiation:
♀ 193.2-206.8 g;
♂ 237.9-2.59.8 g.
-Housing during acclimatisation: in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", SchillAG. CH-4132 Muttenz) during treatment and observation.
-Diet: pelleted standard Provimi Kliba 3433 rat maintenance diet, batch no. 34/02 (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad libitum.
-Water: community tap water from Füllinsdorf ad libitum

ENVIRONMENTAL CONDITIONS
-Temperature: 22 ± 3 °C
-Humidity: 30-70 %
-Air changes: 10-15 air changes per hour
-Photoperiod: 12 hours fluorescent light/ 12 hours dark
-Other: music during the light period.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Remarks:

PEG 300

Details on dermal exposure:

TEST SITE
- Area of exposure: 10 % of the total body surface.
- Type of wrap if used: the dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm tap water and dried with disposable paper towels.

TEST MATERIAL
- Application volume/kg b.w.: 4 ml

VEHICLE
The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.

Duration of exposure:

24 hours after the application the dressing was removed.

Doses:

2000 mg/kg b.w

No. of animals per sex per dose:

5 per sex per dose

Control animals:

not specified

Details on study design:

-Duration of observation period following administration: 14 days
-Frequency of observations (clinical signs): daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.
-Mortality/ Viability: daily during accllmatization and twice daily during days 1-15.
-Frequency of weighing: On test days 1 (prior to administration), 8 and 15
-Necropsy of survivors performed: yes
-Other examinations performed: macroscopic examinations

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No systemic signs of toxicity were observed during the study period. A slight violet discoloration was however present at the test site of all animals from study day 2 to 6.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 (rat): greater than 2000 mg/kg body weight.

Executive summary:

The substance was tested for acute toxicity by dermal route according to the OECD Guidelines 402 (1987) and the method B.3 of Directive 92/69/EEC. Five male and five female Wistar rats were treated with test item at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.5 g/ml and administered at a volume dosage of 4 ml/kg. The application period was 24 hours.

The animals were examined daily during the acclimatization period and mortality, viability, body weghts and clinical signs were recorded during the observation period of 14 days. All animals were necropsied and examined macroscopically.

No deaths occurred during the study. No systemic signs of toxicity were observed during the study period. A slight violet discoloration was present at the test site of all animals from study day 2 to 6. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

The LD50 (rat, dermal) was found to be greater than 2000 mg/kg body weight.