Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]

Endpoint summary

Description of key information

Oral toxicity: LD50 > 2000 mg/kg bw
Inhalation toxicity > 5 mg/m3
Dermal toxicity: LD50 > 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:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets generally accepted scientific principles, acceptable for assessment.

Qualifier:

no guideline available

GLP compliance:

not specified

Test type:

other: no data

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Weight: from 130 to 158 g

Route of administration:

oral: gavage

Vehicle:

water

Doses:

5020, 6310, 7943, 10000 and 12000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 8 582 mg/kg bw

Based on:

act. ingr.

Mortality:

The highest dose rats died within 2-3 hours after the application, the rats of the other doses dies up to 2 days after application.

Clinical signs:

other: no signs of intoxication- Dose of 6300 mg/kg: after half hour: diarrhea- Doses 7900 and 10000 mg/kg: after half hour: diarrhea; after 2 hours: languorous spasms; after 2 days: diarrhea, persists goals, less food- Dose 12000 mg/kg: diarrhea after 20 minu

Gross pathology:

No damage to any organs. The autopsy of the dies rats revealed slightly and evenly colored substance in the body. The surviving rats were killed after 14 days and the autposy revelaed that at doses of 5, 6.3 and 7.9, no macroscopically observable effects were seen; the rats at dose 10 presented liver and kidneys discolouration.

Interpretation of results:

GHS criteria not met

Conclusions:

The tested item was found to be non toxic for oral exposure with a LD50 > 8000 mg/kg bw.

Executive summary:

The acute oral toxicity of Direct Red 80 in rats was assessed with this test over a period of 14 days.

The LD50 value is > 8000 mg/kg of active ingredient.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Velaz Prague- Age at study initiation: 8 weeks- Supplier certification: declared that animals had not the external and internal parasites, pathogenic microorganisms, viruses and fungi.- Housing: after transporting the animals were placed in polypropylene plastic nursery containers T4 (550 x 320 x 180 mm Velaz Prague), five animals each sex separately.- Acclimation period: one week- Diet: fed with granulated mixture ALTROMIN 1320 (Velaz Prague) in a dose of 12 g per animals each day- Water: drinking water without restrictionsENVIRONMENTAL CONDITIONS- Temperature: 22 ± 3°C- Humidity: 40-60 %- Photoperiod: 12 hours of light and 12 hours of darkness

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

head only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION- Exposure apparatus: samples were dosed by WDFU (Wright Dust Feed Unit MK2, GA 4170, L. Adams, LTD., London) diredtly into an inhalation chamber, where they were dispersed through the spray; the atmosphere inside the inhalation chamber was homogeneous.- Method of holding animals in test chamber: animals were fixed in a glass tube of diameter 60 mm so that the face of the glass cylinder to interfere with the vertical axis - 250 mm in diameter- in which there was a linear dynamic atmosphere exchange at 8 l/min.- Source and rate of air: compressed air was taken from the central distribution Synthesia. Air flow was measured continuously throughout the exposure.TEST CONDITIONS- The average air flow apparatus: 0.360 m3/h- The temperature inside the apparatus: 22°C- Relative humidity inside the apparatus: 45-48 %- Actual concentration: 5.044 mg/L airTEST SUBSTANCE- Particle size of the test substance: : diameter 1-4: 409.7 ± 11.86 (85.55 %); diameter 4-10: 53.6 ± 3.72 (11.19 %); diameter 10-20: 13.6 ± 1.42 (2.84 %); diameter >20: 2.0 ± 0.5 (0.42 %)

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 4 h

Concentrations:

5.044 mg/l air

No. of animals per sex per dose:

5 males and 5 non-pregnant females.

Control animals:

yes

Details on study design:

- Immediately after application the animals were removed from tube, placed in breeding containers and observed.- Duration of observation period following administration: 14 days- Frequency of observations and weighing: before exposure and after 7 and 14 day- Other examinations performed: clinical diagnosis was focused on the observation of nutritional status (food intake and water), the appearance of hair and skin, visible mucous membranes, mental activity, somatomotor activity, response to stimuli, focusing on sensitization and reactivity, lacrimation, functional assessment of the respiratory, circulatory, digestive and urogenital apparatus. - After 14 days the animals were killed and an autopsy was performed. At autopsy were examined macroscopically thoracic and abdominal organs and lungs, trachea, larynx, thymus, liver, spleen and kidneys.

Statistics:

No data

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

During the test and during the observation period (14 days) there was no mortality of the tested animals.

Clinical signs:

other:

Body weight:

The increase of body weight of animals tested was in according to the trend of increase of control animals.

Gross pathology:

Immediately thereafter after the 14-day observation period the animals were killed . After an autopsy was performed, focusing on the overall examination of the body surface and orifices, and macroscopic examination of the thoracic, abdominal and selected organs - trachea, lungs, heart, thymus, liver, spleen and kidneys.In one male was present a diffuse pulmonary congestion. In females were observed different effect: - Female 1: numerous punctate hemorrhages on the right lung. No other pathological anatomical findings. - Female 2: No pathological anatomical findings. - Female 3: sharply defined deposits a small pea size founded in the right lung. In the left lung were observed edema. - Female 4: grey-blue sharply defined deposits with size from pinehead to pea were observed in both lungs.- Female 5: Similar findings has been identified as female 4.

Observations during the exposure:

Immediately after application the animals were removed from tubes, placed in breeding containers and observed.

For all the test animals was recorded bristly hair on the head, thoracic limbs and other body parts were fur.

- 60 min after application:

animals presented the same symptoms of intoxication of the first observation

- 120 min after application:

animals presented the same symptoms of previous observations and psychological disorders were observed.

- 2 days after application:

On two males and on 3 females: stains of the test-compound on the hair, discharge of black liquid nasal, and eye irritation, swelling of the eyelids, irregular breathing. For the remaining animals there were no clinical signs of intoxication.

- 3 days after application:

No symptoms were recorded.

- From 4 to 14 days after application: during this period there were no clinical signs of intoxication.

Interpretation of results:

GHS criteria not met

Conclusions:

A sample of Direct Red 80 were tested for limit test for acute inhalation toxicity. During the exposure or during the 14-day observation period there was no death of animals tested. Immediately after the application fault tracing (discharge from the eyes and nose, swelling of the eyelids, conjunctival hyperemia, and irregular breathing) can be considered reversible, nonspecific irritant highly concentrated aerosol dust on the exposed upper respiratory tract mucosa, and conjunctivitis.Symptoms of these changes within 2 days subsided and the course of the 14-day observation period revealed no fault condition in test animals. They were recorded also no differences according to sex of the animals. The reaction of males and females were the same.Autopsy revealed no overall or bearing, macroscopically detectable pathological-anatomical changes.The results of the limit test revealed no adverse effects of test substances on the health of experimental animals.

Executive summary:

Direct Red 80 was tested for acute inhalation toxicity. During exposure and during the 14-day observation period there was no mortality of experimental animals. Based on the results, the tested substance could be considered not toxic for acute toxicity for inhalation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

other: read across friom similar substance

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Few details available on test procedures.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

Wistar

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Interpretation of results:

GHS criteria not met

Conclusions:

According to European Union legislation substance of low toxicity (LD50 >2000 mg/kg b.w.) is not classified to the class of toxicity based on the strength of toxicity in acute exposure conditions.

Executive summary:

According to European Union legislation, substance of low toxicity (LD50 >2000 mg/kg b.w.) is not classified to the class of toxicity based on the strength of toxicity in acute dermal exposure conditions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Direct Red 80 is not toxic by oral, dermal and inhalation route based on the results of the available studies

Justification for selection of acute toxicity – oral endpoint
Study with highest purity of substance and higher doses.

Justification for selection of acute toxicity – inhalation endpoint
One study available

Justification for selection of acute toxicity – dermal endpoint
Study with a more complete report.

Justification for classification or non-classification

According to Regulation EC 1272/2008 (CLP) Direct Red 80 is not classified for Acute toxicity.