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Description of key information

Acute toxicity: oral


Acid Red 407 was assessed for acute toxicity potential in several studies over the years. The acute oral toxicity of FAT 20202/B (active ingredient ca. 71.3 %) was evaluated using methodology similar to OECD Guideline 401. In this study, gropus of rats each containing 5 males and 5 females, were administered FAT 20202/B at 2000, 2500, 3000 and 5000 mg/kg bw via gavage. After administration of the compound, the animals were observed for 14 days. No mortality was seen at 2000 mg/kg bw, however, % mortality observed was 50 (5 females), 70 (2 males and 5 females) and 100 (5 males and 5 females) at 2500, 3000 and 5000 mg/kg bw respectively. Sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position were the clinical signs observed. The surviving animals recovered by day 8. At autopsy no changes caused by the administration of FAT 20202/B were seen.In conclusion, the acute oral LD50 of FAT 20202/B in rats of both sexes observed over a period of 14 days is 2696 mg/kg bw. The acute oral toxicity of FAT 20202/D (active ingredient ca. 27.5 %) was assessed using 3 male and 3 female young albino rats. A single dose of 5000 mg/kg bw was administered via gavage. After administration of the compound, the animals were observed for 14 days. Mortality and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. Dyspnea, ruffled fur, and curved body position were seen, being common symptoms in acute toxicity testing were seen but no deaths occurred. At autopsy no changes caused by the administration of FAT 20202/D were seen.In conclusion, the acute oral LD50 of FAT 20202/D in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw. The oral LD50 for FAT 20202/A (active ingredient ca. 25 %) was determined to be >15000 mg/kg bw from the findings of the study conducted using similar methodology as given in OECD Guideline 401.


 


Acute toxicity: inhalation


Currently no study for assessment of acute inhalation toxicity of Acid Red 407 is available. However, it was estimated to have low vapour pressure (<0.5 KPa) owing to high melting point (> 350 °C), so the potential for the generation of inhalable forms is low. 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. 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 considered to be unlikely. Acid Red 407 was found to have water solubility of 10.9 g/L, hence, if any dust of this hydrophilic substance enters the respiratory tract, it may be retained within the mucus and cleared through mucociliary system. The chemical showed low toxicity potential in the available acute oral toxicity studies with LD50 being 2696 mg/kg bw, hence, it does not need to be classified as STOT SE. Taking the above arguments into consideration, low toxicity potential is expected on acute exposure of Acid Red 407 via inhalation route. Hence, safety for human health can be estimated via route to route extrapolation and testing by the inhalation route was considered scientifically not necessary.


 


Acute toxicity: dermal


Currently no study to assess acute dermal toxicity of Acid Red 407 is available. However, the molecular weight of the chemical is 920.5 g/mol, indicating it being too large for dermal absorption. It has water solubility of 10.9 g/L, indicating it being too hydrophilic to cross the lipid rich environment of the stratum corneum. Hence, the dermal uptake for the chemical is expected to be low. Production and spray drying is performed in closed processes without isolation of reaction products. Isolated products consist either of liquid formulations or of 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. Risk management measures established for workers and professionals are considered sufficient to enable safe handling and use of the final products containing the formulated dye. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50 = 2696 mg/kg bw), and it does not need to be classified STOT SE. Similarly, absence of systemic toxicity in skin irritation as well as sensitization studies further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Hence, testing by the dermal route with Acid Red 407 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:
supporting study
Study period:
Study completion date: 20 March, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Test Substance: FAT 20202/D
Batch No.: 66341.62
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
None
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
None
Doses:
None
No. of animals per sex per dose:
3 animals / sex
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations of mortality and clinical signs: daily
- Necropsy of survivors performed: yes
Statistics:
None
Preliminary study:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality reported.
Clinical signs:
other: Dyspnoea, ruffled fur, and curved body position were seen, being common symptoms in acute toxicity testing. The animals recovered within 12 days.
Gross pathology:
At autopsy, no deviations from normal morphology were found.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of compound FAT 20202/D in rats is greater than 5000 mg/kg bw.
Executive summary:

The acute oral toxicity of FAT 20202/D was assessed using 3 male and 3 female young albino rats. A single dose of 5000 mg/kg bw was administered via gavage. After administration of the compound, the animals were observed for 14 days. Mortality and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. Dyspnea, ruffled fur, and curved body position were seen, being common symptoms in acute toxicity testing were seen but no deaths occurred. At autopsy no changes caused by the administration of FAT 20202/D were seen. In conclusion, the acute oral LD50 of FAT 20202/D in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 696 mg/kg bw
Quality of whole database:
Good quality studies

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the available data from acute toxicity studies with Acid Red 407, it does not meet the criteria for classification for acute toxicity according to the CLP (1272/2008) Regulation.