Disodium 7-[[2-(acetylamino)-4-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]azo]naphthalene-1,3-disulphonate

Endpoint summary

Description of key information

Not harmful/toxic if swallowed.

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:

From March 05th to 26th, 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted May 12, 1981

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 10 to 12 weeks.
- Weight at study initiation: males 213 - 227 g; females 179 - 196 g.
- Fasting period before study: animals were fasted for 12 to 18 hours. Food was again presented approximately one hour after dosing.
- Water: ad libitum.
- Acclimation period: 7 days.

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

- Application volume: 20 ml
- Vehicle: 4 % solution of CMC.
- Preparation: a weight by volume dilution was prepared using a homogenizer. Homogenicity of test article in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made immediately prior to dosing.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

3 males and 3 females

Details on study design:

- Duration of observation period following administration: 14 days

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 deaths occurred during the test

Clinical signs:

other: Sedation, ruffled fur were recorded; rats has recovered within 2 observation days.

Gross pathology:

No macroscopic organ changes were observed.

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) 1272/2008

Conclusions:

LD50 (female and male) > 5000 mg/kg bw

Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the KFM-Han. Wistar rat. The method followed the OECD Guidelines No. 401. A group of three fasted females and three fasted males was treated with the test material at a dose level of 5000 m/kg bw. The test material was administered orally in 4 % solution of CMC. Clinical signs were recorded over the 14 days observation period.

No deaths occurred during the test. Sedation, ruffled fur were recorded; rats has recovered within 2 observation days. No macroscopic organ changes were observed.

The acute oral median lethal dose (LD50) of the test material, in the rat, was estimated as being greater than 5000 mg/kg bodyweight.

Conclusion

LD50 (female and male) > 5000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

ACUTE TOXICITY BY ORAL ROUTE

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the KFM-Han. Wistar rat. The method followed the OECD Guidelines No. 401. A group of three females and three males was treated with the test material at a dose level of 5000 m/kg bw. No deaths occurred during the test. Sedation, ruffled fur were recorde; rats has recovered within 2 observation days. No macroscopic organ changes were observed.

In addition, an old sheet of test results is available, indicating an LD50 greater than 4000 g/kg. Unfortunately, the reliability of the data cannot be judged because of the lacking of details about test material, testing method, procedures and conditions. Data is here reported only for completeness sake.

ACUTE TOXICITY - INHALATION ROUTE

No acute toxicity studies by inhalation route are available on Reactive Yellow 125.

Nevertheless, because of the physical state of the substance inhalation is not an appropriate route of exposure. Particle size distribution showed that the ca 85 % of particles has a diameter greather than 63 µm and that ca 99 % of particles have a diameter higher than 45 µm. Thus, most of the Reactive Yellow 125 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 (i.e. D50 of 4 µm), 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.

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.1 Acute toxicity section, 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 5000 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).

Inhalation exposure is unlikely.

In conclusion, the test substance does not meet the criteria to be classified for oral acute toxicity, according to the CLP Regulation (EC) No 1272/2008.