Chromate(5-), bis[4-(hydroxy-κO)-7-[2-(2-hydroxy-1-naphthalenyl)diazenyl]-3-[2-[2-(hydroxy-κO)- 3-nitro-5-sulfophenyl]diazenyl]-2-naphthalenesulfonato(4-)]-, sodium (1:5)

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:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

415-070-1

EC Name:

-

Molecular formula:

C52H26CrN10Na5O22S4

IUPAC Name:

chromium(3+) pentasodium bis(6-[2-(2-hydroxynaphthalen-1-yl)diazen-1-yl]-2-[2-(3-nitro-2-oxido-5-sulfonatophenyl)diazen-1-yl]-3-sulfonatonaphthalen-1-olate)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: BRL Ltd., Basel, Switzerland
-Age at study initiation: Approx. 9 weeks.
-Weight at study initiation:
male: 204-217 g
female: 167 - 179 g
-Number of animals 5 ♂ and 5 ♀
-Housing: Individually housed in labelled polycarbonate cages containing purified sawdust as bedding material
-Diet: Free access to standard pelleted laboratory animal diet
-Water: Free access to tap-water
-Acclimation period: 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 21 °C
-Humidity (%): 55%
-Air changes (per hr): 15 air changes per hour
-Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light with artificial fluorescent light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

tap water

Details on dermal exposure:

TEST SITE
-Area of exposure: 5x7 cm on the back of the animal was clipped
-% coverage:
5 x 5 cm for male
3.5x5 cm for female
- Type of wrap if used: gauze patch fixed successively to aluminium foil and flexible bandage with drops of petrolatum.

TEST MATERIAL
-Volume: 10 ml/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg b.w

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

-Duration of observation period following administration: 14 days
-Frequency of observations Mortality/Viability: Twice daily
-Frequency of observations clinical signs: At periodic intervals on the day of treatment
(day 1) and once daily thereafter.
-Frequency of observations and weighing: Days 1 (pre-administration), 8 and 15.
-Necropsy of survivors performed: yes
All animals surviving to the end of the observation period (day 15) were sacrificed by oxygen/carbon dioxide asphyxiation. All animals assigned to the study were subjected to necropsy and descriptions of all macroscopic abnormalities recorded.

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 mortality occurred during the study period.

Clinical signs:

other: No clinical signs of ill health or behavioural changes were observed during the study period. Black discolouration of the dorsal skin was ascribed to the staining properties of the test substance and considered not to represent a sign of toxicity.

Gross pathology:

Macroscopic post mortem examination of the animals at termination revealed pelvic dilation of the right kidney in one male only. Renal pelvic dilation is a common finding in animals of this age and strain and therefore considered not related to treatment.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The dermal LD50 exceed 2000 mg/kg body weight.

Executive summary:

The dermal acute toxicity of the substance was evaluated with a limit test to albino rat Wistar, according to the method Directive 92/69/EEC, Annex V of the EEC directive 67/548/EEC; Part B.3 (1992). A 2000 mg/kg bw single dose of the substance was suspended in an aqueous solution and was administered to two groups each of 5 males and 5 females. A gauze patch fixed to aluminium foil and flexible bandage was applied for 24 h to the skin previously shaved. Clinical signs and mortality after administration were recorded during the observation period of 14 days after treatment. Thereafter all animals were submitted to necropsy and macroscopic examination.

No mortality occurred during the study period and no significant toxicological effects were observed. The dermal LD50 value of the substance in rats of both sexes over a period of 14 days was established to exceed 2000 mg/kg bw.