Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(1-sulphonato-2-naphthyl)azo]naphthalene-2,7-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

None

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate

Cas Number:

84045-65-8

Molecular formula:

C31H21Na3ClN7O10S3

IUPAC Name:

Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

None

Test animals

Species:

rat

Strain:

other: Tif:RAIf (SPF)

Remarks:

F3-crosses of RII 1/Tif x RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species and strain: Rat, Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
Initial body weight range: 168-203 g
Initial age: 7-8 weeks
Individual identification: by colour code using picric acid
Husbandry: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
The animal room was air conditionned: temperature 22±3° C, relative humidity 55±15%, 12 hours light/day, approximately 15 air changes/h.

Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80.

Details on oral exposure:

Prior to dosing, the animals were fasted overnight.
Administration: oral, by gastric intubation (gavage)
Volume (ml/kg body weight) applied: 10 and 20

Doses:

2000 and 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer,
- Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days,
- Signs and symptoms: daily,
- Weighing: on days 1, 7, 14 and at death,
- Necropsy of survivors performed: yes,
Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasible, the LD50 including the 95 % confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred at the dose of 2000 mg/kg bw. However, at 5000 mg/kg bw, 3 males and 5 females were found dead within day 1 after treatment.

Clinical signs:

other: Dyspnoea, ruffled fur, diarrhoea and curved body position were seen with the animals treated at 2000 mg/kg bw. Animals treated with 5000 mg/kg bw, also showed sedation, exophthalmos , ventral body position and lateral body position in addition to the prev

Gross pathology:

No gross lesions were found in the animals of the 2000 mg/kg group. With the exception of the two survivors, all animals of the 5000 mg/kg groups had blue stained bodies.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was determined to have a LD50 of >2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test substance was evaluated in a study conducted according to OECD Guideline 401. Two groups of 5 male and 5 female rats received the test item at the doses of 2000 and 5000 mg/kg bw by oral intubation. Observations of mortality and clinical signs were carried out after 1, 2, 3, 5 and 24 hrs of dosing, and daily thereafter for 14 days; while weighing was done on days 1, 7 and 14. Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period. No mortality occurred at the dose of 2000 mg/kg bw. However, at 5000 mg/kg bw, 3 males and 5 females were found dead within day 1 after treatment. Dyspnoea, ruffled fur, diarrhoea and curved body position were seen with the animals treated at 2000 mg/kg bw. Animals treated with 5000 mg/kg bw, also showed sedation, exophthalmos, ventral body position and lateral body position in addition to the previously described signs. The surviving animals recovered within 9-10 days. No effect on body weight gains was seen. No gross lesions were found in the animals of the 2000 mg/kg group. With the exception of the two survivors, all animals of the 5000 mg/kg groups had blue stained bodies. Hence, based on the above findings, the test substance was determined to have a LD50 of >2000 mg/kg bw.