Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate

Endpoint summary

Description of key information

oral LD50 in rats > 15000 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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test parameters documented do not totally comply with a testing guideline but they are sufficient to accept the data, even if pathology was not performed.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

In order to determine the dose/response relationship of the test substance, groups of 5 male and 5 female rats were treated with various single doses of the compound, diluted in distilled water by gavage. Symptoms and mortality after administration were recorded during an observation period of 8 days.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Tif RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 100 g
- Housing: housed in groups of 5 in macrolon cages (Size3)
- Fasting period before study: animals having been fasted overnight
- Diet and water: animals were fed a standard diet of Nafag ad libitum and had free access of drinking water.
- Acclimation period: acclimatized in laboratories for at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 12-hour light period

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Concentration in vehicle: 10 % or 50 %

Doses:

1000, 3000, 10000 and 15000 mg/kg bw

No. of animals per sex per dose:

Groups of 5 male and 5 female rats

Control animals:

no

Details on study design:

Symptoms and mortality after administration were recorded during an observation period of 8 days.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed up to the dose of 15000 mg/kg bw

Clinical signs:

other: No symptoms at doses of 1000 to 3000 mg/kg . Reduction of spontaneous motility was observed after 3 hours after dose administration of 10000 mg/kg . No symptoms have not been recorded after 24 hours. At the dose of 15000 mg/kg, reduction of spontaneous mo

Route of admin.	Dose mg/kg	Vehicle	Concentration (%)	Mortality				Bodyweight (g)		Symptoms
				male	female	%	Day of test	pre-test	day 8 of test
p.o.	1000	dist. water	10	0/5	0/5	0	-	100	170	none
p.o.	3000	dist. water	10	0/5	0/5	0	-	100	171	none
p.o.	10000	dist. water	50	0/5	0/5	0	-	100	168	reduction in spontaneous motility > 3 hours After 24 hours, no symptoms
p.o.	15000	dist. water	50	0/5	0/5	0	-	100	157	ditto, hypoventilation, slight ataxia

Interpretation of results:

not classified

Remarks:

Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions, the test substance was practically devoid of toxicity at each dose level.
The acute oral LD50 in rats was established to be > 15000 mg/kg bw.

Executive summary:

The oral acute toxicity study was performed according to an internal method: groups of 5 male and 5 female rats were treated with various single doses of the compound, diluted in distilled water by gavage. Symptoms and mortality after administration were recorded during an observation period of 8 days.

The acute oral LD50 in rats was established to be > 15000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

15 000 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

Despite the key study was not carried out according to a OECD Guideline, but to an internal method, the test turns out to be sufficiently detailed (even if pathology was not performed). Groups of 5 male and 5 female rats were treated with various single doses of the compound, diluted in distilled water by gavage. Symptoms and mortality after administration were recorded during an observation period of 8 days.

The acute oral LD50 in rats was established to be greater than 15000 mg/kg.

Justification for selection of acute toxicity – oral endpoint

The test results/procedures described do not totally comply with a testing guideline (OECD 401) but they are sufficient in quantity and quality to permit an evaluation of the effects of the test substance.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 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).

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

- category 1: ATE ≤ 5 mg/kg bw

- category 2: 5 < ATE ≤ 50 mg/kg bw

- category 3: 50 < ATE ≤ 300 mg/kg bw

- category 4: 300 < ATE ≤ 2000 mg/kg bw

The acute oral LD50 in rats was established to be greater than 15000 mg/kg bw.

Therefore, the substance is not classified for oral acute toxicity according to the CLP Regulation (EC n. 1272/2008).