Hydrogen bis[1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphtholato(2-)]chromate(1-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Feb 1982 - 26 Feb 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

7 day observation period

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen bis[1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphtholato(2-)]chromate(1-)

EC Number:

250-774-0

EC Name:

Hydrogen bis[1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphtholato(2-)]chromate(1-)

Cas Number:

31714-55-3

Molecular formula:

C32H19Cl2CrN4O4

IUPAC Name:

[1-{[5-chloro-2-(hydroxy-kappaO)phenyl]diazenyl}-2-naphtholato(2-)-kappaO]{1-[(5-chloro-2-hydroxyphenyl)diazenyl]-2-naphtholato-kappaO}chromium

Test material form:

solid: particulate/powder

Details on test material:

Appearance: Dark navy blue powder

Test animals

Species:

mouse

Strain:

other: ddY-N

Remarks:

or

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: not specified.
- Age at study initiation: Young adult animals (approx. 5 weeks old).
- Weight at study initiation: males 22-26g, Females 22-24g.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2

No further details given

Administration / exposure

Route of administration:

oral: gavage

Details on oral exposure:

GAVAGE METHOD:
Administered orally with a gastric tube once

Frequency: single dosage

VEHICLE: Soya bean oil

MAXIMUM DOSE VOLUME APPLIED:
60 mL/Kg body weight

DOSAGE PREPARATION:
15g of the test substance is suspended to soya bean oil, making it to 100 mL (15%)

Doses:

9000 mg/kg body weight
8200 mg/kg body weight
7400 mg/kg body weight
6800 mg/kg body weight
6100 mg/kg body weight

No. of animals per sex per dose:

10 males and 10 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: observations took place 5 hours after administration and in the following days at least once.
- Necropsy on the survivors performed: yes, 7 days post administration
- Bodyweight was measured before administration and 7 days post administration.

Not further details given

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 9 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: The mice got symphtoms of diarrhea 20 minutes after administration for all doses. A darkblue color stained the eyeballs, ears and tails of the mice.

Gross pathology:

There were no abnormalities seen in the main organs except for the liver being dark blue in color.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

An acute oral toxicity study with S-34 in mice was performed similar to OCED 401 guidance. No mortality was observed at dose levels up to and including 9000 mg/kg bw. Based on the results the LD50 for S-34 was determined to be >9000 mg/kg.

Executive summary:

An Acute oral toxicity study similair to OECD guideline 401 was performed with S-34. The test item was orally administered to 10 male and 10 female mice per dose level at 6100 mg/kg bw, 6800 mg/kg bw, 7400 mg/kg bw, 8200 mg/kg bw and 9000 mg/kg bw. Animals were subjected to daily observations and bodyweights were determined before administration and after 7 days. Macroscopic examination was performed at terminal sacrifice (day 7). No mortality occured. Symphtoms of diarrhea were observed 20 minutes after administration for all doses. Bodyweight was maintained or slightly reduced 7 days after administration. All animals displayed darkblue color stained the eyeballs, ears and tails. Necropsy showed no abnormalities except for a blue liver. The oral LD50 for S-34 in mice was established to exceed 9000 mg/kg bw. Based on these results, S-34 is not classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).