5-amino-3-[[4-[[4-[[4-anilino-2-hydroxyphenyl]azo]phenyl]amino]-3-sulphophenyl]azo]-4-hydroxynaphthalene-2,7-disulphonic acid, sodium salt

Endpoint summary

Description of key information

Not harmful/toxic if swallowed

Not harmful/toxic in contact with skin

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 µg/kg bw

Additional information

The following data was obtained for the Similar Substance 01. It is expected that the Target substance will present similar acute oral and dermal toxicity. Justification for the use of a read-across approach is provided in Section 13 of IUCLID.

ACUTE TOXICITY - ORAL ROUTE

Three tests are available for the assessment of the potential oral acute toxicity of Similar Substance 01. In all cases, a single dose of 2000 mg/kg bw of the substance was administered to rats; rats were observed for mortality, clinical signs and vitality for 14/15 days after exposure and necropsy was performed after the observation period.

In the key study, no mortality occurred up to 15 days post-treatment. Males and females exhibited ruffled fur, diarrhea, hunched posture. Additionally, males appeared sedated. All animals had recovered after 10 observation days; the body weight gain was not impacted and no macroscopical findings were seen in any animal.

In the study performed in 2000 one male died after 6 hours; the necropsy of the male that died after 6 hours did not revealed any significant changes. All the other animals survived (i.e. 2 males and 3 females). 10 minutes after exposure, a clear decrease in motor activity was observed in all animals, with postration, piloerection and respiratory distress. 24 hours after administration, there was a notable recovery of symptoms, except for prostration and piloerection. At 48 hours, the symptoms were recovered and the animals appeared normal and survived until the 14th day. No macroscopic changes found after the necropsy of the survived animals.

In the third study, the tested substance was characterized by a lower main component content respect to the other tests. None of the treated animals died. All the animals showed a soft, blackish faeces during the first three days following administration. The body weight gain was not impacted and in the necropsies performed only one male demonstrated a slightly larger right kidney which also had a dilated renal pelvis.

In conclusion, the studies outcomes let to identify the LD50, for both males and females, as higher than 2000 mg/kg bw.

 

ACUTE TOXICITY - INHALATION ROUTE

Considering the physical state and properties of Acid Blue 134, inhalation is not an appropriate route of exposure. Particle size distribution showed that the median mass distribution diameter of Acid Blue 134 resulted to be 27 µm; particles having a diameter lower than 4 µm are less than 1 %. Thus, most of the particles are expected to remain in the upper respiratory tract, which is characterized by efficacious defence mechanisms able to remove them; therefore, respirable particles, able to enter the deepest part of the lung, the non-ciliated alveoli, can be considered a minimal portion. This consideration, together with the consideration that the substance is manufactured and handled with suitable risk management measures and with the suitable personal protective equipments, lets to consider the possible absorption of the substance by inhalation route as negligible.

 

ACUTE TOXICITY - DERMAL ROUTE

Similar Substance 01 was assayed for acute dermal potential toxicity; the experiment was conducted according to the OECD guideline 402. Test item was administered to rats by a single semi-occlusive dermal application at the concentration of 2000 mg/kg bw, with an observation period of 15 days; all the animals were subjected to necropsy at the end of the observation period.

No dead occurred during the experiment and no macroscopic findings were noted. All animals, showed a black-coloured back, from the 2nd day until the end of the observation period, but no mortality occurred.

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.1 acute toxicity section, acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours. Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

Dermal LD50 value was established to be greater than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute dermal toxicity (dermal acute toxicity category 4: 1000 < ATE ≤ 2000 mg/kg bw).

Inhalation exposure is unlikely; no acute toxicity value is available and no further investigation is required.

In conclusion, the substance is not classified for oral, nor dermal acute toxicity, according to the CLP Regulation (EC) No 1272/2008.