Reaction mass of 1,5-Naphthalenedisulfonic acid, 3,3'-[(4-methyl-1,2-phenylene)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino[2-(acetylamino)-5-methoxy-4,1-phenylene]-2,1-diazenediyl]]bis-, sodium salt (1:4) and 1,5-Naphthalenedisulfonic acid, 3,3'-[(3-methyl-1,2-phenylene)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino[2-(acetylamino)-5-methoxy-4,1-phenylene]-2,1-diazenediyl]]bis-, sodium salt (1:4)

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:

From January to February 1989

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:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Specific pathogen free (SPF) Wistar-derived albino rats (Alpk:APfSD strain)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Barrierd animal breedign unit
- Age at study initiation: Young adutls
- Weight at study initiation: 254-280 g form males and 189-212 g for females
- Fasting period before study: overnight
- Housing: Rats were housed in suspended cages (37 cm length × 32 cm width × 20 cm height). The floor and back of the each were made of 1.2 cm square stainless steel mesh.
- Diet (e.g. ad libitum): Portion combined diet (PCD)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionised

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Every day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology,

Statistics:

N/A

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality

Clinical signs:

No sings of toxicity were absorved in any of the animals. Both female and male animals produced faeces stained ornage on Day 1 of the study faeces appeared normal on Day 2.

Body weight:

All animals decreased body weight from day -1 to day 1 due to overnight fasting. By day 3 all rats had gained weight compared to day -1. Weight gain continued until the end of the study.

Gross pathology:

No macroscopic abnormalities were detected at necropsy

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 (oral, gavage) of the test substance was >2000 mg/kg bw in male/female rats. The substance is not classifiable according to CLP criteria.

Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance in Alpk:APfSD rats in compliance with GLP. Five male and five female animals were gavaged at single dose of 2000 mg/kg bw, then observed for 14d. There was no mortality and no signs of toxicity were observed in any of the animals. Under the study conditions, the LD50 of the test substance was >2000 mg/kg bw (Ishmael, 1989).