Trisodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromate(3-)

Endpoint summary

Description of key information

Oral LD50 rat > 2000 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:

From December 20th, 2001 to 29th January, 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to internationally accepted testing guidelines. Some details about testing procedures and test conditions are missing.

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 22 March 1996

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

not specified

Test type:

acute toxic class method

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Sprague-Dawley Crl:CD (SD) IGS BR rat (SPL Standard Test Method 512.08).
Fasted before treatment.

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

The test material was administered orally as a suspension in distilled water.

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

Three fasted females followed by a group of three fasted males.

Details on study design:

Clinical signs and bodyweight development were monitored during the study.
All animals were subjected to gross necropsy.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Red coloured staining of the faeces and urine was noted in all animals during the day of dosing and one day after dosing. No other signs of systemic toxicity were noted.

Gross pathology:

No abnormalities detected.

Individual Bodyweights and weekly Bodyweight changes

Animal Number and Sex	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
	0	7	14	1	2
1-0 Female	218	250	265	32	15
1-1 Female	241	275	302	34	27
1-2 Female	212	230	235	18	5
2-0 Male	239	312	363	73	51
2-1 Male	224	301	350	77	49
2-2 Male	221	291	344	70	53

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 rat > 2000 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 Sprague-Dawley. The method followed the OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 22 March 1996), EU Commission Directive 96/54/EEC Method B1 tris Acute Oral Toxicity (Oral - Acute Toxic Class Method).

A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level. The test material was administered orally as a suspension in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths. Red coloured staining of the faeces and urine was noted in all animals during the day of dosing and one day after dosing. No other signs of systemic toxicity were noted. Necropsy did not reveal any abnormalities.

Conclusion

LD50 rat > 2000 mg/kg bw

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 study available

Additional information

ORAL ACUTE TOXICITY

The acute oral toxicity of Acid Violet 090 (AV090) potential was investigated in Sprague-Dawley rats. The experiment was conducted according to the OECD guidelines 423 (Acute Toxic Class Method). The animals were treated with a single dose of 2000 mg/kg bw. No deaths were recorded at the end of the study; red coloured staining of the faeces and urine was noted in all animals during the day of dosing and one day after dosing. No other signs of systemic toxicity were noted. Necropsy did not reveal any abnormalities (Clariant SE, 2002).

Furthermore, a summary reporting some toxicological characteristics of AV090 (85 %; remaining composition sodium chloride and sodium sulfate) is available; unfortunately the original study reports are not more available. The available information included in the toxicological characteristics sheet indicate an LD50 p.o. for rats of ca 9000 mg. Dyspnea, apathie, slowed movement sequences, systemic redness, diarrhea, dehydration were reported as clinical observations (BASF SE, 1976).

ACUTE TOXICITY - DERMAL ROUTE

The 15^th Meeting of Competent Authorities for REACH and CLP (CARACAL, 2014) concluded acute dermal toxicity is not necessary for substances that have shown no toxicity in acute oral toxicity test up to the limit dose of 2000 mg/kg bw. Furthermore, the Commission services agree that information on acute toxicity via the dermal route should indeed be provided in cases where indications for systemic toxicity in other studies with dermal application (skin irritation or sensitisation studies) has been observed (with the exception of cases where the substance has been shown to be corrosive to skin). The acute oral toxicity test perfomed on DBl221 did not show systemic toxicity (SCAS Europe S.A./N.V., 1997).

Curerntly, only a summary reporting some toxicological characteristics of AV090 (85 %; remaining composition sodium chloride and sodium sulfate) is available, which includes information on acute dermal toxicity. Unfortunately the original study reports are not more available. The information included in the toxicological characteristics sheet indicate an LD50 dermal for rats higher than 2500 mg (BASF, 1976).

REFERENCE

CARACAL, 2014. 15th Meeting of Competent Authorities for REACH and CLP (CARACAL), 8 – 9 July 2014. Charlemagne building, Brussels, Belgium. Brussels, 26 July 2014. Doc. CA/61/2014. Stakeholder proposal to modify REACH standard information

BASF SE. 1976. Ergrbnis der gewerbetoxikologischen vorprüfung. Testing laboratory: BASF AG. Date: 1976-11-26

Justification for classification or non-classification

According to the CLP Regulation (EC 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 higher 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).

There are no experimental data for dermal, however, based on the physicochemical properties and based on the acute oral toxicity study outcomes, no adverse effects are expected for this exposure route.

In conclusion, the test substance is non classified for oral acute toxicity, according to the CLP Regulation (EC 1272/2008).