Sodium [3-hydroxy-4-[(1-hydroxy-8-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

Endpoint summary

Description of key information

 LD50(oral) = 5000 mg/kg bw; LC50(inhal) > 2.8 mg/l; LD50(ip) = 380 mg/kg bw.

  
    
    
    
    
    
    
    

Acute intraperithoneal administration: LD50

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Study conducted before 1981

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
- Age at study initiation: 7 weeks
- Weight at study initiation: 192 g (♂) and 151 g (♀).
- Housing: Rats were caged singly
- Diet: A commercial pelleted diet ad libitum
- Water: ad libitum
- Fasting period before study: 18 hours

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: a 25 % (w/v) suspension of the compound in tap water.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
Deaths and clinical symptoms wars recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the 14 day observation period.

Clinical signs:

other: No clinical symptoms were recorded

Gross pathology:

At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Interpretation of results:

other: Not classified according to the CLP Regulation (EC n. 1272/2008)

Conclusions:

LD50(male/female) > 5000 mg/kg bw

Executive summary:

The substance has been tested for acute toxicity after oral exposure, the test item was administered by gavage in a single dose of 5000 mg/kg bw to rats (5 male and 5 female).

After the administration, the animals were observed for 14 days. No deaths occurred and no clinical symptoms were recorded.

The acute oral median lethal dose LD50 of test item in rats is greater than 5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 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

Study period:

August 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

no

Remarks:

Study conducted before 1981

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin and Kingman Ltd
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: 180-200 g
- Housing: They were caged in groups of five by sex in solid floor polypropylene cages furnished with sterilised sawdust. Sawdust was replaced twice per week
- Diet : free access to mains water and food (Rat ar..d Mouse No. 1 Expanded Diet, BP Nutrition (UK) Ltd., Stepfield, Witham, Essex)
- Acclimation period: 3 days before exposure

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 10 %
- Air changes (per hr): The ventilation system gave 8-10 air changes per hour
- Photoperiod (hrs dark / hrs light): controlled lighting conditions

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A Timbrell dust generator was used to produce the atmosphere.
- Source and rate of air: 10 l/min

ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 0.86 µm

Analytical verification of test atmosphere concentrations:

yes

Remarks:

by gravimetric analysis

Duration of exposure:

ca. 4 h

Concentrations:

Calculated from compound usage (after exposure): 29.8 mg/l
Calculated from gravimetric analysis: 2.8 mg/l

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for toxic or pharmacological effects during exposure and subsequently at least twice daily through a 14 days observation period.
- Frequency of weighing: immediately after expasure and an days 1, 3, 7, 10 and 14 after the day of exposure.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LC0

Effect level:

ca. 2.8 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.8 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No deaths occurred during exposure or during the observation period as a result of exposure to the test material. One male treated rat suffocated as a result of turning around in the restraining tube.

Clinical signs:

other: For 1-2 days after exposure, male and female treated rats were hypothermic and lethargic. They bad nasal excretion, laboured and rattling respiration, discoloured faeces and urine and stained and ruffled pelts. The staining of pelts and faeces persisted t

Body weight:

The mean body weights of the male and female control rats throughout the experiment, increase slowly during the first 4 days but thereafter more rapidly.

Gross pathology:

Those dying an the day of exposure also showed staining of the upper respiratory tract, however in the remainder of the rats which survived the observation period, there was a more generalised pulmonary staining.Staining of the renal cortex occurred in four male rats, and staining of the general musculature and testes in one male.

All the treated rats had blue stained pelts.

Interpretation of results:

other: Not classified according to the CLP Regulation (EC n. 1272/2008)

Conclusions:

LC50 > 2.8 mg/l

Executive summary:

The study was conducted according to a method similar to OECD Guideline 403. A single maximum concentration of test material (2.8 mg/l calculated from gravimetric analysis; 29.8 mg/l calculated from compound usage) was administered to 20 rats (10 male, 10 female) as a dust by inhalation (nose only) over a period of 4 hours. A further 10 rats (5 male, 5 female) were exposed under similar conditions to an atmosphere of filtered air. The concentration of test material, as measured by gravimetric analysis was 2.8 mg/l. No deaths occurred during exposure or during the observation period as a result of exposure to the test material. For 1-2 days after exposure, male and female treated rats were hypothermic and lethargic. They bad nasal execretion, laboured and rattling respiration, discoloured faeces and urine and stained and ruffled pelts. The staining of pelts and faeces persisted throughout the observation period.

The substance shows a LC50 more than 2.8 mg/l.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

2.8 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral administration:

Three studies are available on acute oral toxicity conducted on the target substance.

The Key study (Huntsman, 1975) was performed with a method similar to the OECD Guideline 401. The test item was administered to rats in a single dose by gavage at the concentration of 5000 mg/kg bw. No deaths occurred during the observation period.

LD50 > 5000 mg/kg bw

As supporting studies the two other studies available on the target substance were reported:

The first study (BASF, 1979) was performed with a method similar to the OECD Guideline 401. The test item was administered to rats in a single dose by gavage in distilled water at the concentration of 2000 mg/kg bw. No deaths occurred during the observation period.

LD50 > 2000 mg/kg bw

The second study (BASF, 1979) was performed with a method similar to the OECD Guideline 401. . The test item was administered to rats in a single dose by gavage in CMC (carboxymethyl cellulose) at the concentration of 5000 mg/kg bw. No deaths occurred during the observation period, nevertheless blue urine and foeces were observed.

LD50 > 5000 mg/kg bw

The three study of acute oral administration are similar, the main reason for selection is the highest purity of the Huntsman study conducted in 1975.

 

Acute inhalation administration:

One study is available by inhalation route. This study (BASF, 1978) was performed according to a method similar to OECD Guideline 403. A single concentration (2.8 mg/l calculated from gravimetric analysis; 29.8 mg/l calculated from compound usage) was administered to rats as a dust by inhalation (nose only) over a period of 4 hours. No deaths occurred during exposure or during the observation period as a result of exposure to the test material.

For 1-2 days after exposure, male and female treated rats were hypothermic and lethargic. They bad nasal excretion, laboured and rattling respiration, discoloured faeces and urine and stained and ruffled pelts. The staining of pelts and faeces persisted throughout the observation period.

LC50 > 2.8 mg/l

 

Acute intraperitoneal administration

One study is available by intraperitoneal route. This study (BASF, 1978) was performed according to the method described in “Hazieton Manual of Standard Operating Procedures”. As preliminary study the animals were treated with a single intraperitoneal dose of test article at a dose level of 2000 mg/kg. All animals died within 24 hours of treatment. Following the initial study other mice were treated with a single intraperitoneal dose of test article within the range 216 - 1470 mg/kg. Deaths occurred in all the concentration tested.

LD50 = 380 mg/kg bw

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or an inhalation exposure of 4 hours.

The LC50 value for the oral administration is higher then 2000 mg/kg bw (LD50 > 5000 mg/kg bw) that is the trigger value for the acute oral toxicity classification.

The tested concentration in the acute inhalation exposure study is not above the value for avoiding the classification according the CLP Regulation (EC n. 1272/2008) but the tested value is an LC0 and the corresponding LC50 is more than 2.8 mg/l, therefore no classification is warranted for acute inhalation exposure.

Otherwise, the intraperitoneal administration is not considered as a route relevant for the classification pourpose.

Based on the data above, the substance is not classified for acute oral and inhalation toxicity.