A mixture of: sodium/potassium 7-[[[3-[[4-((2-hydroxy-naphthyl)azo)phenyl]azo]phenyl]sulfonyl]amino]-naphthalene-1,3-disulfonate

Endpoint summary

Description of key information

The acute oral and dermal median lethal dose (LD50) of test substance in rats of both sex was greater than 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:

07 July 1992 to 05 August 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Test article: FAT 45155/B
Trade name: ERIONYL ROT HT 3728
Batch No.: HT 3728/TV 1
Purity: 60 - 70 %
Physical properties: powder; dark red
Storage conditions: room temperature; keep dark
Validity: May 15, 1997

Species:

rat

Strain:

other: Tif: RAI f

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal production, 4332 Stein / Switzerland
- Weight at study initiation: 189 - 228 g
- Housing: test animals were housed in Macrolon cages type 4, with standardized soft wood bedding.
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) were provided ad libitum
- Fasting period before study: overnight
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2
- Humidity (%): 55 ± 10
- Air changes (per hr): about 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours/day light cycle

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled water

Details on oral exposure:

one single oral dose by gastric intubation

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

10 test animals (5 males and 5 females)

Control animals:

no

Details on study design:

Administration of the test article: one single dose, gavage by gastric intubation
Dose level: 2000 mg/kg (males and females)
Total number of test animals: 10
Vehicle: distilled water
Volume applied: 20 ml/kg body weight
Observation period: 14 days

Observations and records:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Body weight: immediately before administration and on days 7 and 14
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.

Statistics:

No data

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred in this study.

Clinical signs:

other: Pil'oerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, reduced locomotor activity was observed in all animals. The animals recovered within 6 days.

Gross pathology:

At autopsy, a spotted thymus was found in 4 males, one of them was involuted additionally. In the same animal, a spotted liver was seen.

Other findings:

No data

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose (LD50) in rats after oral administration was greater than 2000 mg/kg.

Executive summary:

A GLP-compliant acute oral toxicity study in Tif RAI f rats (5/sex) was carried out with FAT 45155/B and observed for a 14 day post-treatment observation period. The study was carried out according to OECD guideline 401. There was no mortality observed during the study. Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, reduced locomotor activity was observed in all animals. The animals recovered within 6 days. At autopsy, a spotted thymus was found in 4 males, one of them was involuted additionally. In the same animal, a spotted liver was seen. Based on the study results, the median lethal dose (LD50) in rats after oral administration was greater than 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP-compliant guideline study

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

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:

01 April 1992 to 01 September 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Test article: FAT 45155/B
Trade name: ERIONYL ROT HT 3728
Batch No.: HT 3728/TV 1
Purity: 60 - 70 %
Physical properties: powder; dark red
Storage conditions: room temperature; keep dark
Validity: May 15, 1997

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein/ Swizerland
- Age at study initiation: Young adult rats
- Weight at study initiation: 210 - 265 g
- Housing: test animals were housed in Macrolon cages type 3, with standardized soft wood bedding.
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2
- Humidity (%): 55 ± 10
- Air changes (per hr): about 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours/day light cycle

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: Back of rat
- % coverage: 10 %
- Type of wrap if used: Adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg

Duration of exposure:

24 h

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

10 test animals (5 males and 5 females)

Control animals:

no

Details on study design:

Approximately 24 hours before treatment an area on the back of the rat of at least 10 % of the body surface was shaved with an electric clipper. The test article was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly. All animals found spontaneously dead or been sacrificed (either for humane reasons or at the termination of the study) were subjected to a complete necropsy.

Administration of the test article: one single dose
Dose level: 2000 mg/kg (males and females)
Total number of test animals: 10
Vehicle: distilled water
Volume applied: 4 ml/kg body weight
Observation period: 14 days

Statistics:

No data

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred in this study.

Clinical signs:

other: Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. At the application site, erythema was observed until day 7 in the males and day 9 in the females. The females developed necrosis. The animals recovered within 10 days

Gross pathology:

At necropsy, no deviations from normal morphology were found.

Other findings:

No data

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose (LD50) of FAT 45155/B in rats after dermal application was greater than 2000 mg/kg.

Executive summary:

A GLP-compliant acute dermal toxicity study in Tif RAI f rats (5/sex) was carried out with FAT 45155/B and observed for a 14-day post-treatment observation period. The study was carried out according to OECD guideline 402. There was no mortality observed during the study. Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. At the application site, erythema was observed until day 7 in the males and day 9 in the females. The females developed necrosis. The animals recovered within 10 days. The test article adhered to the skin until day 5 in males and day 6 in females. At necropsy, no deviations from normal morphology were found. Based on the study results, the median lethal dose (LD50) of FAT 45155/B in rats after dermal application was greater than 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP-compliant guideline study

Additional information

Acute Oral Toxicity:

A GLP-compliant acute oral toxicity study in Tif RAI f rats (5/sex) was carried out with FAT 45155/B and observed for a 14 day post-treatment observation period. The study was carried out according to OECD guideline 401. There was no mortality observed during the study. Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. Additionally, reduced locomotor activity was observed in all animals. The animals recovered within 6 days. At autopsy, a spotted thymus was found in 4 males, one of them was involuted additionally. In the same animal, a spotted liver was seen. Based on the study results, the median lethal dose (LD50) in rats after oral administration was greater than 2000 mg/kg.

 

Acute Inhalation Toxicity:

Currently no study to assess the acute inhalation toxicity potential of Acid Red 447 is available. However, the vapour pressure for the substance can be considered low owing to the high melting point (>299 °C). Hence, the substance is considered to have low volatility. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Further, the chemical is found to have water solubility of 48 g/L and have low log partition coefficient (-1.14), hence in the case of dust of the substance entering the respiratory tract, it will be trapped in the mucus and cleared, thereby further limiting the absorption. The chemical showed low toxicity potential in the available acute oral and dermal toxicity studies (LD₅₀ >2000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified STOT SE. Similarly, absence of local toxicity in skin irritation study, further supports the conclusion that low toxicity is expected for the chemical via the inhalation route. Taking the above arguments into account, low toxicity potential is expected on acute exposure of Acid Red 447 via inhalation route and hence testing by the inhalation route was considered scientifically not necessary.

Acute Dermal Toxicity:

A GLP-compliant acute dermal toxicity study in Tif RAI f rats (5/sex) was carried out with FAT 45155/B and observed for a 14-day post-treatment observation period. The study was carried out according to OECD guideline 402. There was no mortality observed during the study. Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. At the application site, erythema was observed until day 7 in the males and day 9 in the females. The females developed necrosis. The animals recovered within 10 days. The test article adhered to the skin until day 5 in males and day 6 in females. At necropsy, no deviations from normal morphology were found. Based on the study results, the median lethal dose (LD50) of FAT 45155/B in rats after dermal application was greater than 2000 mg/kg.

Justification for classification or non-classification

Based on the observed LD₅₀of >2000 mg/kg bw in the acute oral and dermal toxicity study, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.