Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)

Endpoint summary

Description of key information

In an acute oral toxicity study conducted according to the OECD Guideline 401 in rats (BASF SE, 1981), the oral LD50 was determined to be ca. 1400 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:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

prior to GLP implementation

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: food depreviation 15 - 20 hours before test substance administration.
- Diet: standardized animal laboratory diet

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

Form of administration: suspension
Concentrations used: 16.5, 24.2, 35.6 % (w/v)
Administration volume: 5, 7.3, 10.8 mL/kg

Doses:

825, 1210, 1780, 2610, 3830 mg/kg bw

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 400 mg/kg bw

Mortality:

Males: 825 mg/kg: no deaths; 1210 mg/kg: 3/5 after 14 days; 1780 mg/kg: 1/5 after 14 days; 2610 mg/kg: 4/5 after 14 days; 3830 mg/kg: 5/5 after 14 days
Females: 825 mg/kg: no deaths; 1210 mg/kg: 3/5 after 14 days; 1780 mg/kg: 4/5 after 14 days; 2610 and 3830 mg/kg: 5/5 after 14 days

Clinical signs:

other: Dyspnea, apathy, staggering, feces and urine orange-coloured, diarrhea, poor general state

Gross pathology:

Died animals:
heart: acute dilatation of the atrium; acute congestive hyperemia
organs/fat tissues/musculature: substance-coloured

Sacrificed animals:
organs: nothing abnormal detected

Interpretation of results:

Category 4 based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 400 mg/kg bw

Quality of whole database:

Klimisch code 2

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

In the available study (BASF SE, 1981) the acute toxic effects of the test substance were investigated after a single oral gavage to rats. The investigations were performed in accordance with OECD guideline 401. The test substance (purity > 95 %) was (suspended in olive oil) administered once orally via gavage to fasted Sprague-Dawley rats (male/female, 5 animals/dose) at doses of 825, 1210, 1780, 2610, and 3830 mg/kg bw. Body weight was determined before administration and 14 days after the administration (p.a.). Clinical observations were performed at least once per day during the 14 days observation period and all animals were sacrificed and necropsied at the end of the observation period. Body weight development of both sexes was within the normal range of the rat strain. The following clinical signs were observed: dyspnea, apathy, staggering, diarrhea, and poor general state. Mortality after the 14 days observation period occurred at all dose groups except in the 825 mg/kg bw group (1210 mg/kg bw: 3/5, 1780 mg/kg bw: 1/5, 2610 mg/kg bw 4/5, 3830 mg/kg bw: 5/5). Based on the mortality, an LD50 of 1400 mg/kg bw was determined.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.

An LD50 of 1400 mg/kg bw for acute oral toxicity was determined. As a result, the substance is considered to be classified for acute oral toxicity (Category 4, H302) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.