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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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-trisulfonate
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:
No symptoms were observed after single doses of 5000 and 15000 mg/kg.
Body weight:
Growth was not delayed in either treatment group.
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.