Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)

Endpoint summary

Description of key information

In two acute oral toxicity studies in rats LD50 values of  above 7000 mg/kg bw and above 7750 mg/kg bw were determined.

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:

1979-11-27 to 1980-01-16

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No details on test item purity are given.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: RAI strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in house breed
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: male: 189-200 g; Female: 170-181 g
- Fasting period before study: overnight
- Housing: groups of 5 in macrolon cages (Type 3)
- Diet: ad libitum, standard diet (NAFAG, Gossau SG)
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Photoperiod (hrs dark / hrs light): 14/10

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 20 mL/kg bw

Doses:

4000, 5000, 6000, 7000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily, weighing once a week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

LD50 including 95 % confidence limits are calculated by the logit model.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Animals of all dosing groups developed slight symptoms like dyspnoea, exophthalmos, ruffed fur, diarrhoea and showed a curved body posture. All animals recovered within 8 to 9 days.

Gross pathology:

No gross internal lesions were observed in any of the animals.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of the test item in rats of both sexes observed over a period of 14 days is greater than 7000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

7 000 mg/kg bw

Quality of whole database:

Non GLP study. Meets generally accepted scientific standards.

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

Acute Oral Toxicity

In the key study groups of 10 fasted animals (5/sex/dose) were exposed to 4000, 5000, 6000, 7000 mg/kg bw of test substance diluted in polyethylene glycol followed by a 14 day observation period. No mortality was observed. All animals gained weight throughout the study period. Slight clinical signs were observed like dyspnoea, exophthalmos, ruffed fur and diarrhoea. Recovery of the animals was observed after 8 to 9 days. No gross internal lesions were observed during necropsy. A LD50 above 7000 mg/kg bw was determined.

In a supporting study groups of 10 fasted animals (5/sex/dose) were exposed to 4640, 6000, 7750 mg/kg bw of test substance diluted in polyethylene glycol. No mortality was observed and all animals gained weight throughout the study period. Slight clinical signs were observed like sedation, dyspnoea, exophthalmos and ruffed fur. Recovery of the animals was observed after 9 to 11 days. No gross internal lesions were observed during necropsy. In this study, the LD50 was determined to be greater than 7750 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled for acute oral toxicity under Regulation (EC) No 1272/2008.