Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)

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:

other: Study conducted according to internationally accepted testing guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)

EC Number:

274-230-7

EC Name:

Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)

Cas Number:

69943-66-4

Molecular formula:

C32H18CrN8O14S2Na3

IUPAC Name:

Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Velaz Prague.
- Weight at study initiation: about 200 g (range 200-270 g).
- Housing: individually, in plastic polypropylene cages T3 (supplied by s.p. Velaz Prague).
- Diet: animals were fed with commercial granular food mixture Altromin 1320, supplied by s.p. Velaz Prague. Daily dose of 20 g/animal/day.
- Fasting period before study: the day before of the test, animals were not fed.
- Water: CSN 767111 ad libitum.
- Bedding: wood shavings, from light wood.
- Acclimation period: 1 week.
Cleaning and disinfection of premises menagerie were made at dates determined, according to the standard operating procedures and compliance regime measures.

ENVIRONMENTAL CONDITIONS
- Temperature: controlled temperature at 22 ± 3 °C.
- Humidity: 50 ± 15 %.
- Photoperiod: 12 hrs dark / 12 hrs light, by fluorescent lamp.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: during one week were twice shaved in the back, for an area of 6 x 6 cm.
- Type of wrap if used: gauze soaked with acetone ethyl alcohol in ratio 1:1 and gauze soaked with physiological solution. Treated skin was covered with gauze, aluminium foil and fixed by technical tape applied to the circumference of the trunk; this was accompanied by a fixation bandage. The dressing was covered with technical tapes and attached around the circumference of the trunk, in order to maintain the test substance in contact with the skin and in order to avoid swallowing of the substance.

TEST MATERIAL
- Solution: weighed sample was added to water and mixing with a metal spatula, to form an aqueous paste.

Duration of exposure:

24 hours

Doses:

5020 mg/kg

No. of animals per sex per dose:

Groups of 6 rats x dose (one group as control).

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: immediately before the substance application, rats were weighed. Immediately after application, ca 30 minutes, after 3 hours post-application. The day after the application the observations were made in the morning and in the afternoon, while in the following days at least once daily. Body weight was measured at the beginning and end of the experiment.
- Necropsy of survivors performed: yes; internal organs were assessed for colour, size, consistency and structure.
- Other examinations performed: appearance of the skin, hair, visible mucous membranes status, mental activity, somatomotor activity, reactivity to stimulus, lacrimation, respiration, digestion, urogenital and circulatory systems. Organs and muscles were examined macroscopically. If post-mortem the bladder of animals was full, the urines were analyzed focusing on the detection of proteins, blood sugar, ketones, bilirubin, urobilinogen and pH.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Clinical signs:

other: Throughout the duration of the experiment, no signs of intoxication were observed. Visual examination did not reveal differences in hair, skin, mucous membranes.

Gross pathology:

Hair, skin, mucous membranes: normal.
Subcutaneous and muscles: without macroscopical patomorphological changes.

Other findings:

Results after autopsy:
animals appeared in a good status, with normal motorial activity, reactivity and sensibility.
functionality of digestive, urogenital and circulatory systems appeared normal.
head and neck: with normal motorial activity, reactivity and sensibility.
lung: pink colour, spongy consistency, ventilation without macroscopic pathomorphological changes.
stomach: full of food, without macroscopic pathomorphological changes.
guts: filled with sparse mushy food, without macroscopic pathomorphological changes.
liver: dark reddish brown colour, smooth surface, stiffer consistency, without macroscopic pathomorphological changes.
spleen: red colour, stiffer consistency, without macroscopic pathomorphological changes.
kidney: brownish-red colour, surface smooth, stiffer consistency, without macroscopic pathomorphological changes.
bladder: without macroscopic pathomorphological changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU

Conclusions:

LD50 > 5000 mg/kg.

Executive summary:

The acute toxicological characterization of the substance was determined by Acute toxicity test, according to the OECD guideline 402.

Two groups of six rats (one dosed and one used as control) were administered with 5020 mg/kg of test material. Treated skin was covered with gauze, aluminium foil and fixed by technical tape applied to the circumference of the trunk; this was accompanied by a fixation bandage. The dressing was covered with technical tapes and attached around the circumference of the trunk, in order to maintain the test substance in contact with the skin and in order to avoid swallowing of the substance. Test substance was removed after 24 hours and the observation period was of 14 days.

Throughout the duration of the experiment, no signs of intoxication were observed. Visual examination did not reveal differences in hair, skin, mucous membranes.

Conclusion

The LD50 resulted greater than 5000 mg/kg by dermal application.