Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

Endpoint summary

Description of key information

The LD50 for FAT 20290/A was found to be >5000 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:

1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation:7-8 weeks
- Diet: Rat food, NAFAG No. 890, NAFAG AG,Gossau, SG (Switzerland); ad libitum
- Water: ad libitum
- Housing: Animals were caged in groups of 5 in Macrolon cages type 3 with standardized soft wood bedding
- Fasting: Prior to dosing, the animals were fasted overnight.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity: 55±15%
- Air changes: Approximately 15 air changes per hour
- Photoperiod: Light cycle of 12 hours light and 12 hours dark

Route of administration:

oral: gavage

Vehicle:

other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80

Details on oral exposure:

Volume (ml/kg body weight) applied: 20

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.
- Other examinations performed: body weight, clinical symptoms

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Preliminary study:

A preliminary study was not conducted.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occured.

Clinical signs:

other: Clinical signs such as dyspnoea, exophthalamos, ruffled fir, diarrhoea and curved body position were observed during the study.

Gross pathology:

No compound related gross organ changes were observed.

Other findings:

None

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of FAT 20290/A after single oral administration to male/female rats, observed over a period of 14 days is >5000 mg/kg bw.

Executive summary:

The acute oral toxicity potential of FAT 20290/A was evaluated in a study conducted according to OECD Guideline 401. Ten Tif:RAIf (SPF) rats that included 5 males and 5 females, were treated with FAT 20290/A by oral gavage administration at a dosage of 5000 mg/kg bw. The animals were examined daily during the observation period and mortality and clinical signs were recorded. Body weights were recorded on day 1 (prior to administration) and on days 7 and 14. All animals were necropsied at the end of the observation period. All animals survived until the end of the study period. Clinical signs such as dyspnea, exophthalmos, ruffled fir, diarrhea and curved body position were observed during the study. Dyspnea and exophthalmos were noted till Day 13, ruffled fur was noted till day 8. The body weight of the animals was within the range commonly recorded for this strain and age. No compound related gross organ changes were observed. Based on these findings, the median lethal dose of FAT 20290/A after single oral administration to rats observed over a period of 14 days is >5000 mg/kg bw.            

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Good quality 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

Data waiving:

other justification

Justification for data waiving:

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral:

In an acute oral toxicity study performed according to OECD guideline 401, ten Tif:RAIf (SPF) were treated with FAT 20290/A by oral gavage administration at a dosage of 5000 mg/kg bw. All animals survived until the end of the study period and no changes in the body weight and macroscopic findings were observed. Based on these observations, median lethal oral dose (LD50) to rats of FAT 20290/A was found to be >5000 mg/kg bw.

Inhalation:

Currently no study to assess the acute inhalation toxicity potential of Acid Blue 314 is available. However, the vapour pressure for the target chemical is considered to be low owing to the high melting point >350 °C, hence its considered to have low volatility. The median particle size of Acid Blue 314 was 49.468 µm, which indicates that the chemical may not be able to reach the alveolar region respiratory tract. Water solubility of the chemical was determined to be 302 g/L, meaning the dust particles of the chemical may be retained within the mucus. 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 was found to have low acute toxicity when tested via oral route with no mortality when tested at 5000 mg/kg bw. Hence, considering all the above arguments, it is considered that Acid Blue 314 has a low toxicity potential via inhalation route and thus the study on acute inhalation toxicity is considered scientifically not necessary. 

Dermal:

Currently no study to assess acute dermal toxicity of Acid Blue 314 is available. However, the molecular weight of the chemical is 545.413 g/mol, indicating it being too large for dermal absorption. Hence, the dermal uptake for the chemical is expected to be low.The partition coefficient (n-octanol/water) of Acid Blue 314 was determined to be -5.62, while the water solubility was 302 g/l.These physicochemical properties indicate chemical istoo hydrophilic to cross the lipid rich environment of the stratum corneum, supporting the hypothesis that dermal uptake for the chemical will be low. The chemical showed low toxicity potential in the available acute oral toxicity study (LD50 >5000 mg/kg bw), with no mortality being seen. Similarly, absence of systemic toxicity in skin irritation as well as sensitization studies, further supports the conclusion that no adverse effects are expected for the chemical via the dermal route. Further experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic application. Hence, low toxicity is expected on acute dermal exposure of Acid Blue 314 and testing by the dermal route was considered scientifically not necessary.

Justification for classification or non-classification

Based on the observed LD50 of >5000 mg/kg bw in acute oral study, Acid Blue 314 does not need to be classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.