Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1991 to November 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in ocmpliance with GLP. No test guidlinee is specified within the study report; however the method is considered comparable to OECD Guideline 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

No details of test guidance referenced within the study report; however the method is equivalent to OECD Guideline 401.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate

EC Number:

413-550-5

EC Name:

Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate

Cas Number:

142068-96-0

Molecular formula:

Hill formula: C53H28Cl2N14Na8O26S8

IUPAC Name:

octasodium 5-[(4-chloro-6-{[4-({[4-chloro-6-({7-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-8-hydroxy-3,6-disulfonatonaphthalen-1-yl}amino)-1,3,5-triazin-2-yl]amino}methyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]-3-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate

Details on test material:

The test sample (reference: NBY 405/74) was received as a dark brown powder. It was sent for testing from ICI Specialties, Blackley, Manchester, UK. A certificate of analysis (reference: 9103127 and dated 8 August 1951) stated that the test sample contained 71.6% (w/w) substance H112339 and 10.5% (w/w) moisture. From information supplied by the sponsor the test sample was used within the stated expiry date.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Specific pathogen free (SPF) Wistar-derived albino rats (Alpk:APfSD strain) were supplied by the Barriered Animal Breeding Unit, ICI Pharmaceuticals, Alderley Park, Macclesfield, Cheshire, UK. The rats were young adults and at the beginning of the study they weighed 241-250g for males and 180-199g for females.

The rats were housed in suspended cages (37-5cm length x 32.5cm width x 23.0cm height). The cages were constructed of stainless steel, two sides being sheet and the remainder 14 standard wire gauge mesh. A maximum of five rats were housed in each cage and the sexes were kept separately.

The animals were allowed free access to food (Porton Combined Diet, Special Diets Services Ltd: Appendix A) and given unlimited access to water via an automatic system.

The room in which the rats were held was designed to maintain a temperature of between 19°C and 23°C and a relative humidity of 55±15%. Temperature and relative humidity were recorded constantly. The air-exchange system was designed to give 25-30 air-changes per hour and the light pattern was controlled by a time switch to give alternate periods of 12 hours of artificial light and 12 hours of darkness.

The rats were acclimatised to the animal laboratory for a minimum of six days prior to the study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionised

Details on oral exposure:

The test sample was given the CTL reference number Y07719/OQ1/001 and was tested as a preparation in deionised water.

The main study was preceded by a preliminary study (speculative oral study] in which a dose level of 2000mg/kg was tested on a small group of animals. Based on information from this study the dose-level for the main study was selected as 2000mg/kg. The dose level was adjusted to account for the moisture content, therefore a dose of 2234.6mg/kg test substance as supplied was administered which is approximately equal to 2000mg/kg of the test material excluding water.

Doses:

2000mg/kg body weight

No. of animals per sex per dose:

Five male and five female rats were used for this study.

Control animals:

no

Details on study design:

Five male and five female rats were used for this study. Each animal was given a number, unique within the study, using an ear-punch. Each animal was weighed and then fasted overnight for a period of up to 24 hours.

The main study was preceded by a preliminary study (speculative oral study] in which a dose level of 2000mg/kg was tested on a small group of animals. Based on information from this study the dose-level for the main study was selected as 2000mg/kg. The dose level was adjusted to account for the moisture content, therefore a dose of 2234.6mg/kg test substance as supplied was administered which is approximately equal to 2000mg/kg of the test material excluding water.

The rats were given a single oral dose of the test sample as a preparation in deionised water. A standard volume of 10ml/kg was dosed to each animal. The volume of the dose was calculated for each animal according to its weight at the time of dosing. The preparation was administered by gavage using a 12.5cm long plastic catheter attached to a sterile disposable plastic syringe of suitable size for the volume eg 2ml or 5ml.

The animals were observed for signs of systemic toxicity once within 2 hours of dosing and again between 4 and 7 hours after dosing. Subsequent observations were made once daily, or twice daily whenever there were significant signs of toxicity, up to day 15. The animals were weighed on the day before dosing (day -1), the day of dosing (day 1) and on day 3, day 4, day 8 and day 15.

At the end of the study, all of the animals were humanely killed by inhalation of excessive levels of halothane BP (FLUOTHANE, ICI Pharmaceuticals) vapour followed by exsanguination. The animals were given a gross post mortem examination.

Statistics:

No data

Results and discussion

Preliminary study:

The main study was preceded by a preliminary study (speculative oral study] in which a dose level of 2000mg/kg was tested on a small group of animals. Based on information from this study the dose-level for the main study was selected as 2000mg/kg.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no signs of toxicity and none of the animals died.

Clinical signs:

other: The faeces, urine, coat and tail of the animals were stained red by the test sample but this is considered not to be of toxicological significance.

Gross pathology:

There were no macroscopic abnormalities detected in any of the animals at the post mortem examination.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose of substance HI12339 was greater than 2000mg/kg to both male and female rats.

Executive summary:

The report was conducted in accordance with the following Good Laboratory Practice (GLP), no test guidance is referenced within the study report although this is deemed equivalent to OECD Guideline 401.

 

 A group of five male and five female rats received a single oral dose of 2000mg/kg substance H112339.   The animals were assessed daily up to day 15 for any signs of toxicity and their bodyweights were recorded at intervals.

 

No signs of systemic toxicity were observed and none of the animals died.

 

The acute oral median lethal dose of substance HL12339 was greater than 2000mg/kg to both male and female rats.