Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate

Endpoint summary

Description of key information

Acute Oral Toxicity:

Acute oral toxicity test was conducted according to OECD 401 guideline and in accordance with GLP in 1996. In this study the test substance was administered to a Wistar rats (5/sex) by oral gavage, at a single dose of 2000 mg test substance / kg body weight. There were no deaths as a result of treatment with the test article, no clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the normal range for rats of this strain and age and no organ abnormalities were observed at necropsy. Based on the study results, the mean lethal dose (LD₅₀) of FAT 20075/B after single oral administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg.

 

Acute Inhalation Toxicity:

Currently no study to assess acute inhalation toxicity of Acid Red 252 is available. However, low vapour pressure (1.13 × 10^-3Pa) for the substance and the high melting point (>350 °C), the substance is considered to have low volatility. Synthesis 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. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate, the exposure via inhalation is unlikely. The chemical showed low toxicity potential in the available acute oral (LD₅₀>2000 mg/kg bw), with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Taking into consideration the above arguments, low toxicity potential is expected on acute exposure of Acid Red 252 via inhalation route.

 

Acute Dermal Toxicity:

Currently no study to assess the acute dermal toxicity of Acid Red 252 is available. However, this substance found to have high molecular weight 626 g/mol, this indicates that partition of the substance from stratum corneum into the epidermis will be low, thereby further limiting the absorption if any dermal exposure occurs. Synthesis of this chemical is performed in a closed process without isolation of reaction products. Isolated products consist of either liquid formulations or dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur. The chemical showed low toxicity potential in the available acute oral (LD₅₀>2000 mg/kg bw), with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Similarly, absence of local toxicity in eye and skin irritation studies as well as absence of systemic toxicity in sensitization studies, further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Taking into consideration the above arguments, low toxicity potential is expected on acute exposure of Acid Red 252 via dermal route and hence acute toxicity testing by the dermal route was considered scientifically not necessary.

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:

27 October 1995 to 10 November 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

The relative humidity recorded in the experimental room was outside the range specified in the protocol (37-74 %).

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 1.56
- Expiration date of the lot/batch: June 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container in the refrigerator (8 °C) away from direct sunlight.
- Stability under storage conditions: Stable under stated storage condition
- Stability of the test substance in the solvent/dispersant/vehicle/test medium: Unknown in bi-distilled water, therefore is excluded from the statement of compliance.

Species:

rat

Strain:

Wistar

Remarks:

Hanlbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4 4414 Füllinsdorf / Switzerland
- Age at study initiation: males: 8 weeks; females: 10 weeks
- Weight at study initiation: males: 197.1 - 208.8 g; females: 176.0 - 189.6 g
- Fasting period before study: overnight fasting prior to application
- Housing: Groups of five in Makrol on type-4 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet: Pelleted standard Kliba 343, Batch no. 66/95 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum
- Water: Community tap water from Füllinsdorf, available ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 37-74
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux) / 12 hours dark

IN-LIFE DATES: From: 20-Oct-1995 To: 08-Jan-1996

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight

DOSAGE PREPARATION (if unusual): 2000 mg/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Four times during test day 1 and daily during days 2-15 and weighing is done on test day 1 (pre-administered), 8 and 15 day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology.

Statistics:

None.

Preliminary study:

No mortality observed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs of toxicity were observed during the observation period.

Gross pathology:

No organ abnormalities were observed at necropsy.

Other findings:

None.

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 of FAT 20075/B is greater than 2000 mg/kg body weight.

Executive summary:

Acute oral toxicity test was conducted according to OECD 401 guideline and in accordance with GLP in 1996. In this study the test substance was administered to a Wistar rats (5/sex) by oral gavage, at a single dose of 2000 mg test substance / kg body weight. There were no deaths as a result of treatment with the test article, no clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the normal range for rats of this strain and age and no organ abnormalities were observed at necropsy. Based on the study results, the mean lethal dose (LD₅₀) of FAT 20075/B after single oral administration to rats of both sexes, observed over a period of 14 days is 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:

OECD guideline and GLP compliance study

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the observed LD₅₀of >2000 mg/kg bw in the acute oral toxicity study, Acid Red 252 does not considered to be classified according to according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.