A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 21. Sep. 1987 to 05. Oct. 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate

EC Number:

402-850-1

EC Name:

A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate

Molecular formula:

not applicable for UVCB substance

IUPAC Name:

trichromium(3+) nonasodium 6-[2-(2-amino-4-hydroxyphenyl)diazen-1-yl]-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate 6-[2-(2-amino-6-hydroxyphenyl)diazen-1-yl]-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate 6-[2-(4-amino-2-hydroxyphenyl)diazen-1-yl]-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate tris(6-{2-[(1Z)-2-hydroxy-1-(phenylcarbamoyl)prop-1-en-1-yl]diazen-1-yl}-2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate)

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madörin AG, 4414 Füllinsdorf, CH
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: males 259 to 295 g; females 199 to 222 g
- Fasting period before study: overnight
- Housing: individually in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz, CH)
- Diet: ad libitum; pelleted standard Kliba 343, batch 77/87 rat maintenance diet ("Kliba", Klingentalmühle AG, 4303 Kaiseraugst, CH) (analytical test report demonstrates suitability)
- Water: ad libitum; community tap water from Itingen (bacteriological assay and chemical water analysis demonstrated suitability)
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature 22 °C ± 3 degrees
- Humidity: 40 to 70 %
- Air changes: 10 to 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Remarks:

A weight/volume dilution was prepared using a homogeniser.

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area
- Preparation: shaved with electric clippers 24 hours before treatment
- % coverage: 10 % of body surface area
- Type of wrap if used: occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Removal: washed with lukewarm tap water, dried with disposable paper towel
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2000 mg/kg bw made up to 4 ml polyethylene glycol
- Constant volume or concentration used: yes
- Other details: homogeneity of test item in the vehicle was maintained during treatment using a magnetic stirrer

Duration of exposure:

24 hours

Doses:

4 mL at 2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: 4 times during test day 1, and daily during days 2 to 15
- Necropsy of survivors performed: yes
- Other examinations performed:
- signs and symptoms (4 times on test day 1, then daily on days 2 to 15)
- body weights (pre-treatment, day 8 and day 15)
- mortality (4 times on test day 1, then daily on days 2 to 15)
- macroscopic findings (necropsy)
- Details on specific signs and symptoms:
General behaviour: aggressiveness, vocalisation, restlessness / excitation, nervousness, fear, sedation, somnolence, sleep, coma
Respiration: apnoea, dyspnea, rales
Eye: chromodacryorrhea, exophthalmos, miosis, mydriasis, whitish discharge, lid adhesion
Nose: rhinorrhoea, epistaxis
Motility: akinesia, ataxia, dropped head, hyperkInesia, hypokinesia, paralysis (flaccid), paralysis (spastic), paddling movements, stiff movements, rolling movements
Body posture: ventral body position, latero-abdominal position, hunched posture
Motor susceptibility: spasms, tonic muscle spasms, clonic muscle spasms, opisthotonus, saltatory spasms, trismus, retching, "Straub" phenomenon, tremor, muscle-twitching, muscle-twitching (generalised)
Skin: erythema, oedema, necrosis, crusts, scale formations
Various: loss of weight, emaciation, negative corneal reflex, diarrhoea, ruffled fur, necrosis of tissue of application area, salivation, pallor, cyanosis

Statistics:

The LOGIT-model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Local black discolouration observed from 24 hours after application in both males and females.

Gross pathology:

No macroscopic organ changes were observed. No pathological changes.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC) No.1272/2008

Conclusions:

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

Executive summary:

Acute dermal toxicity of the test item was evaluated in an experimental study performed according to the OECD Guideline 402 (1987) and the EU Method B.3 (1984). 2000 mg/kg bw, made up to 4 ml polyethylene glycol, was applied to the shaved, dorsal region of 10 rats of both sexes with an occlusive bandage for a period of 24 hours in a limit test without a negative control. Animals were monitored daily for 15 days for mortality, toxic symptoms and body weight changes. All animals were subjected to gross pathological analysis after sacrifice at the end of the study period.

No mortality was observed. Local discolouration was observed after removal of the bandage (24 hours after application) until end of the observation period. Body weights of the animals remained constant. No pathological changes were observed at necropsy. The LOGIT-Model could not be applied to these data. The acute dermal toxicity of the test item in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg bw. Therefore, it can be extrapolated that the LD50 is greater than 2000 mg/kg bw.