Sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)

Endpoint summary

Description of key information

Male and female rats were subjected to acute oral toxicity testing according to a protocol similar to OECD TG 401. The test item was administered at dose levels of 4640, 6000 and 7750 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period one male died and there were no ab normalities found in necropsy, thus leading to an LD50 > 7750 mg/kg bw.

Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.

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:

comparable to guideline study with acceptable restrictions

Remarks:

Test performed prior to the implementation of the current acknowledged testing and GLP guidelines . The test conduct however was in principle very similar to the OECD TG 401 as adopted in 1981. Important aspects (e.g. 14 day-postobservation time) were considered.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-guideline study

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy breeding colony, SPF-breed
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 180 g
- Fasting period before study: during one night before starting the treatment
- Housing: Macrolon cages type 3, 5 animals per cage
- Diet: NAFA rat diet, Gossau SG, ad libitum
- Water. water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 1°C
- Humidity: ca 50 %

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 % suspension

Doses:

4640, 6000 and 7750 mg/kg bw

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 700 mg/kg bw

Based on:

test mat.

Mortality:

one male animal of the high dose group died within 24 h

Clinical signs:

other: within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days

Gross pathology:

No gross organ changes were seen in dead and killed animals at scheduled necropsy.

Table 1: individual results

[mg/kg bw]
			1 hour		24 hours		48 hours		7 days		14 days
	m	f	m	f	m	f	m	f	m	f	m	f
4640	5	5	0	0	0	0	0	0	0	0	0	0
6000	5	5	0	0	0	0	0	0	0	0	0	0
7750	5	5	0	0	1	0	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Remarks:

Regulation (EC) 1272/2008

Conclusions:

4640, 6000 and 7750 mg test item per kg bw were administered in male and female rats. During the 14 days observation period 1 male died, resulting in a LD50 > 7750 mg/kg bw.

Executive summary:

Male and female rats were subjected to test acute oral toxicity according to a protocol similar to OECD TG 401. The test item was administered at dose levels of 4640, 6000 and 7750 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period one male died and there were no ab normalities found in necropsy, thus leading to an LD50 > 7750 mg/kg bw.

Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

7 750 mg/kg bw

Quality of whole database:

2 reliable with restrictions

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Not classified

Mortality occurred only at a dose far above the limit dose of 2000 mg/kg bw.