Octasodium 2-(6-(4-chloro-6-(3-(N-methyl-N-(4-chloro-6-(3,5-disulfonato-2-naphthylazo)-1-hydroxy-6-naphthylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,5-disulfonato-1-hydroxy-2-naphthylazo)naphthalene-1,5-disulfonate

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Wistar derived albino rat specific pathogen free (SPF) (alpk: APfsd strain)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Barriered animal breeding unit, Zeneca Pharmaceutical, Alderley Park, Macclesfield, Cheshire, UK.
- Age at study initiation: young adults
- Fasting period before study: Over night fasting before the study
- Weight at study initiation: males 288-315 g and female 209-240 g
- Housing: The rats were housed in suspended cages (32.5 cm x 37.5 cm x 23 cm). The cages were made of stainless steel, with two solid sheet sides, a mesh front and floor and a vented sheet rear. A maximum of five rats was housed in each cage and the sexes were kept separately.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1
- Humidity (%): 51 ± 15%
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Maximum dose volume: 10 mL/kg bw

Doses:

2000 mg/kg bw nominal

No. of animals per sex per dose:

5 male and 5 female

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systemic toxicity once within 2 hours of dosing and again between 4 and 7 hours after dosing. Subsequent observations were made once daily up to Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Preliminary study:

No signs of evident toxicity were observed and the animal survived to the scheduled termination. The tail, faeces and urine of this animal were stained red by the test material.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: All animals survived to the scheduled termination and there were no signs of evident toxicity. The coat, tail faeces and urine of all test animals were stained red/orange by the test material.

Gross pathology:

Post mortem examination revealed discoloration of a number of tissues in one of the female animals. In the absence of any overt clinical signs of toxicity or significant decreases in bodyweight, this discolouration is considered to be of no toxicological significance. Red spots were also seen on the lungs of 2 males. This is a common spontaneous finding in this age and strain of rat and is considered to be unrelated to treatment.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the acute oral LD50 of the substance in rats was determined to be greater than 2000 mg/kg bw.

Executive summary:

A study was conducted to determine the acute oral toxicity of the substance in Wistar rats according to OECD Guideline 420, in compliance with GLP. A group of 5 females and 5 males were dosed with 2000 mg/kg bw of the test substance through oral gavage. The animals were observed for signs of systemic toxicity once within 2 h of dosing and again between 4 and 7 h after dosing. Subsequent observations were made once daily up to Day 15. The following observations and examinations were performed: mortality / viability, clinical signs, body weight, clinical pathology and macroscopy at termination. All animals survived to the scheduled termination and there were no signs of evident toxicity. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be greater than 2000 mg/kg bw (Robinson, 1993).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity:

A study was conducted to determine the acute oral toxicity of the substance in Wistar rats according to OECD Guideline 420, in compliance with GLP. A group of 5 females and 5 males were dosed with 2000 mg/kg bw of the test substance through oral gavage. The animals were observed for signs of systemic toxicity once within 2 h of dosing and again between 4 and 7 h after dosing. Subsequent observations were made once daily up to Day 15. The following observations and examinations were performed: mortality / viability, clinical signs, body weight, clinical pathology and macroscopy at termination. All animals survived to the scheduled termination and there were no signs of evident toxicity. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be greater than 2000 mg/kg bw (Robinson, 1993).

Justification for classification or non-classification

Based on the results of an acute oral toxicity study in rats, the substance does not warrant classification according to EU CLP (EC 1272/2008) criteria.