Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14.08.1972 to 31.08.1972

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

Data is from study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute toxicology study was conducted by using the given test chemical in male Wistar rats.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

EC Number:

228-783-6

EC Name:

Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

Cas Number:

6358-69-6

Molecular formula:

C16H10O10S3.3Na

IUPAC Name:

trisodium 8-hydroxypyrene-1,3,6-trisulphonate

Details on test material:

- IUPAC Name: Trisodium 8-hydroxypyrene-1,3,6-trisulphonate
- Common Name: Pyranine
- InChI: 1S/C16H10O10S3.3Na/c17-11-5-12(27(18,19)20)8-3-4-10-14(29(24,25)26)6-13(28(21,22)23)9-2-1-7(11)15(8)16(9)10;;;/h1-6,17H,(H,18,19,20)(H,21,22,23) (H,24,25,26);;;/q;3*+1/p-3
- Smiles: c12c3c4c(cc(c3ccc2c(S([O-])(=O)=O)cc(c1cc4)S([O-])(=O)=O)O)S([O-])(=O)=O.[Na+].[Na+].[Na+]
- Molecular formula:C16H7Na3O10S3
- Molecular weight :524.389 g/mole
- Substance type:Organic

Test animals

Species:

rat

Strain:

Wistar

Remarks:

TNO/W.70, SPF

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: Adult, about 7 to 40 weeks old
- Weight at study initiation: average initial weight of 181 g (5000 mg/kg) or 134 g (15000 mg/kg).
- Housing: caged in groups of 5 males
- Diet (e.g. ad libitum): "Altromin 1324 - Housing Diet of Rats and Mouse "in pellet form
- Water (e.g. ad libitum): tap water ad libitum (drink bottles).
- Acclimation period: several days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%):50 ± 10%
- Air changes (per hr): about 10-fold air changes per hour
- Photoperiod (hrs dark / hrs light): twelve-fold He11 / Dunke1 rhythm (artificial lighting).

IN-LIFE DATES: From: 14.08. 1972 To: 31.08.1972

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

0.5% aqueous solution of methylcelulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5000 mg/kg and 15000 mg/kg
- Amount of vehicle (if gavage): 20 and 30 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 15000 mg/kg bw

Doses:

5000 and 15000 mg/kg bw

No. of animals per sex per dose:

10 male rats per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days (14- (5000 mg / kg) or 7- (15000 mg / kg) -day)
- Frequency of observations and weighing: On the day of the application, twice a day (once on weekends during non-public holidays).
Body weight – Animals were weighed, before the application, after one week and at the end of the observation period in groups.
- Necropsy of survivors performed: yes, all died during the trial and all at the end of the trial, sacrificed in deep diethyl ether narcosis were pathologically anatomically assessed.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal of dose group 5000 mg/kg bw died within the first 24 hours after application. Due to of the lack of mortality in the high dose of 15000 mg/kg bw, a connection between the death of this animal and the administration of the test substance appears unlikely.

Clinical signs:

other: No symptoms were observed after single doses of 5000 and 15000 mg/kg.

Gross pathology:

Indications of fatty liver was observed in 5000 and 15000 mg/kg bw.

Other findings:

In the high dose group organs and muscles were colored by the substance.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute oral toxicity dose (LD50) was considered to be >15000 mg/kg bw, when 10 per dose male Wistar TNO/W.70, SPF rats were treated with the given test chemical via oral gavage route.

Executive summary:

The acute oral toxicity study was conducted by using the given test chemical in 10 per dose male Wistar TNO/W.70, SPF rats at the dose concentrations of 5000 and 15000 mg/kg bw.

The given test chemical was dissolved in 0.5% aqueous solution of methylcellulose and administered as 20 and 30 ml/kg bw via oral gavage route.

Animals were observed for mortality, on the day of the application, twice a day (once on weekends during non-public holidays). Animals were weighed, before the application, after one week and at the end of the observation period in groups. Necropsy of survivors performed. All animals that died during the trial and all at the end of the trial, sacrificed in deep diethyl ether narcosis were pathologically anatomically assessed.

One animal of dose group 5000 mg/kg bw died within the first 24 hours after application. Due to of the lack of mortality in the high dose of 15000 mg/kg bw, a connection between the death of this animal and the administration of the test substance appears unlikely. No symptoms were observed after single doses of 5000 and 15000 mg/kg. Growth was not delayed in either treatment group. Indications of fatty liver was observed in 5000 and 15000 mg/kg bw. In the high dose group organs and muscles were colored by the substance.

Under the condition of the study, the LD50 value was considered to be >15000 mg/kg bw, when 10 per dose male Wistar TNO/W.70, SPF rats were treated with the given test chemical via oral gavage route.