Chromium (III) complexes with 2-[{2,4-dihydroxy-3-[(5-sulfo-1-naphthyl)diazenyl]phenyl}diazenyl]benzoic acid (1:2), sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 March 2015-21 April 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This study was conducted following the OECD Guideline No. 423 and it was subjected to periodic inspections by the Quality Assurance Unit in compliance with the OECD Principles of Good Laboratory Practice (OECD 1998). tudy conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chromium (III) complexes with 2-[{2,4-dihydroxy-3-[(5-sulfo-1-naphthyl)diazenyl]phenyl}diazenyl]benzoic acid (1:2), sodium salts

EC Number:

700-953-9

Molecular formula:

C46H26CrN8O14S2.3Na

IUPAC Name:

Chromium (III) complexes with 2-[{2,4-dihydroxy-3-[(5-sulfo-1-naphthyl)diazenyl]phenyl}diazenyl]benzoic acid (1:2), sodium salts

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

batch n° M14/165
purity: 100% (UVCB)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Source: Bred and reared at INTOX PVT. LTD.
Age at treatment: 9 to 10 weeks
The experimental animal room was supplied with fresh and filtered air, with 10 to 15 air changes per hour. The room was air conditioned with temperature between 19 to 25 °C, relative humidity 30 to 70% and illumination cycle set to 12 hours light and 12 hours dark. Animals were housed in room number AR-31, in the experimental animal facility of INTOX PVT. LTD., maintained under appropriate barriers. Animals were housed in sterilised solid bottom polypropylene cages with stainless steel grill tops facilities for food and water bottle, and with bedding of clean and sterilised paddy husk. Cages were suspended on movable stainless steel racks. Three animals of same dose group were housed in one cage.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Oral route is a route of accidental exposure in humans.

Doses:

300 to 2000 mg/kg body weight

No. of animals per sex per dose:

6 females for 300 mg/kg bw
6 females for 2000 mg/kg bw

Control animals:

no

Details on study design:

all animals were observed for signs of toxicity and death, periodically during the first 24 hours with special attention given during the first 4 hours (i.e. at 10 minutes, 30 minutes, 1 hour, 2 and 4 hours following dosing) and thereafter they were observed once a day for 14 days.

The body weights were individually recorded at day 0, day 1, day 7 and aon day 15.

All animals in the study were subjected to a complete necropsy and the gross pathological changes were recorded.

Statistics:

No statistical analysis was performed because of the small sample size and absence of controls.

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Acid Brown 432 did not cause any mortality following treatment on the day of dosing and also throughout the observation period of 14 days following dosing.

Clinical signs:

other: Acid Brown 432 did not induce any abnormal clinical signs

Gross pathology:

No gross pathological alterations were encountered in any of the female rats when sacrificed at termination of the test

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In conclusion, all animals receiving the highest dose of 2000 mg/kg bodyweight showed no signs of toxicity.

Executive summary:

This study was performed to assess the acute toxicity of the test article, Acid Brown 432 by single oral gavage administration to Wistar rats and to classify according to the criteria for classification of Regulation 1272/2008/EC. Mortality, clinical signs and bodyweight changes were monitored throughout the study. All animals were examined macroscopically.

According to the test guideline, three fasted female rats were used for each step. The starting dose of 300 mg/kg bw was selected. Three additinal rats were also fed with the same dose and any sign of toxicity and mortality were observed. The third step was a limit dose of 2000 mg/kg bw. None of the doses caused signs of toxicity or mortality.