Sodium 6-amino-5-[[2-[(ethylphenylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Endpoint summary

Description of key information

Oral LD50 (rat) > 2000 mg/kg bw

Dermal LD50 (rat) > 2000 mg/kg bw

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

Study period:

June from 7th to 30th, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: 5 to 8 weeks old
- Weight at study initiation: males 157 - 171 g; females 140 - 157 g.
- Fasting period before study: overnight fast immediately before dosing.
- Housing: animals were housed in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding.
- Diet: Rat and Mouse Expanded Diet, ad libitum.
- Water: ad libitum.
- Acclimation period: at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Humidity: 42 - 57 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: 12 hours light and 12 hours darkness.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

TEST MATERIAL
- Preparation: test material was freshly prepared, as required, as a suspension at the appropriate concentration in distilled water. The concentration, homogeneity and stability of test material preparation were not determined by analysis.
- Concentration: 200 mg/ml
- Dose volume: 10 ml/kg. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

1 male and 1 female for range-finding
5 males and 5 females for main test

Details on study design:

RANGE-FINDING
- Duration of observation: the animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days.
- Frequency of observations and weighing: individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes.
- Necropsy of survivors performed: no necropsies were performed.

MAIN STUDY
- Duration of observation: the animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
- Frequency of observations and weighing: individual bodyweights were recorded prior to dosing on day 0 and on days 7 and 14.
- Necropsy of survivors performed: animals were killed by cervical dislocation and subiected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

RANGE-FINDING
No deaths occurred.

MAIN STUDY
No deaths occurred.

Clinical signs:

other: RANGE-FINDING No clinical signs of toxicity were recorded. MAIN STUDY Red-coloured diarrhoea was noted in all males and two females four hours after dosing. No other signs of systemic toxicity were noted. Red-coloured staining of the fur was noted in all

Gross pathology:

MAIN STUDY
No abnormalities were noted at necropsy.

Interpretation of results:

other: not classified, according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 (rat) > 2000 mg/kg bw

Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD guideline 401. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination.

There were no deaths. Red-coloured diarrhoea was noted in all males and two females four hours after dosing. No other signs of systemic toxicity were noted. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

Conclusion

LD50 (rat) > 2000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: CFYstrain

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: in the weight range 252 to 281 g.

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST MATERIAL
The substance was prepared as a 75 % aqueous suspension and administered at a dogase volume of 6.7 ml/kg bw by spreading evenly over the prepared skin.

TEST SITE
- Area of exposure: on the day prior to treatment, hair was removed from the dorso-lumbar region of each rat with electric clippers. No shaving or chemical depilation was used.
- % coverage: an area equivalent to 10 % of the total body surface.
- Type of wrap if used: the treated area was covered with aluminium foil, which was held in place with "Sleek" waterproof plaster encircled firmly round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: the treated area of skin decontaminated by washing with warm (40-50 °C) dilute soap solution, rinsing in clean warm water and finally blotting dry with absorbent paper.
- Time after start of exposure: 24 hours.

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 rats

Control animals:

yes

Remarks:

using water alone

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations: treated skin were examined daily for signs of local irritation.
- Necropsy of survivors performed: all rats were sacrificed and examined macroscopically.

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no mortalities.

Clinical signs:

other: Slight lethargy only was observed in all animals in the 24 hours following treatment. No signs of irritation to the skin were seen during the two week observation period. Recovery of all animals, as judged by external appearance ond behaviour, was apparen

Gross pathology:

Autopsy findings were normal.

Interpretation of results:

other: not classified, according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 male > 5000 mg/kg bw

Executive summary:

Ten male rats were used to evaluate the acute dermal toxicity potential of the test item. The substance was prepared as a 75 % aqueous suspension and administered at a dogase volume of 6.7 ml/kg bw (5 g/kg bw) by spreading evenly over the prepared skin. The treated area was covered with aluminium foil, which was held in place with "Sleek" waterproof plaster encircled firmly round the trunk. After 24 hours of exposure, the treated area of skin was decontaminated by washing with warm (40-50 °C) diluted soap solution. During the observation period of 14 days, a record was kept of all signs of toxicity. All rats were sacrificed terminally and examined macroscopically. No death occurred.

Slight lethargy only was observed in all animals in the 24 hours following treatment. No signs of irritation to the skin were seen during the 2-week observation period.

Recovery of all animals, as judged by external appearance and behaviour, was apparently complete within 4 days of treatment. Autopsy findings were normal.

Conclusion

LD50 male > 5000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

ORAL ROUTE

The acute oral toxicity potential of Acid Red 057 was investigated in two different experiments.

In the key study, performed according to the OECD guideline 401, following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water at a dose level of 2000 mg/kg bw. No deaths occurred during the experiment. Red-coloured diarrhoea was noted in all males and two females four hours after dosing. No other signs of systemic toxicity were noted. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

The second test available confirms the studies outcomes above mentioned. The substance was prepared a an aqueous suspension and was administered by oral intubation at a dosage volume of 16.7 ml/kg bodyweight (dose of 5 g/kg bw). During the observation period of 14 days no death occurred. Signs of reaction to treatment, observed shortly after dosing, were a slight to moderate lethargy, pilo-erection, diarrhoea and diuresis. Recovery of the treated rats, as judged by external appearance and behaviour, was apparently complete within two days of treatment. Autopsy findings were normal.

DERMAL ROUTE

Ten male rats were used to evaluate the acute dermal toxicity potential of the Acid Red 057. The substance was prepared as a 75 % aqueous suspension and administered at a dosage volume of 6.7 ml/kg bw (5 g/kg bw) by spreading evenly over the prepared skin. During the observation period of 14 days, no death occurred. Slight lethargy only was observed in all animals in the 24 hours following treatment. No signs of irritation to the skin were seen during the 2-week observation period. Recovery of all animals, as judged by external appearance ond behaviour, was apparently complete within 4 days of treatment. Autopy findings were normal.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to a numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

 

The oral LD50 value was established to be greater than 2000 mg/kg, therefore test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

 

The dermal LD50 value was established to be greater than 5000 mg/kg, therefore test substance is out of any classification limit for acute dermal toxicity (dermal acute toxicity category 4: 1000 < ATE ≤ 2000 mg/kg bw).

 

In conclusion, test substance does not meet the criteria to be classified for oral/dermal acute toxicity.