Hydrogen hydroxy[2-hydroxy-3-[(2-hydroxy-3-nitrobenzylidene)amino]-5-nitrobenzenesulphonato(3-)]chromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Endpoint summary

Description of key information

The oral LD50 was clearly above 10000 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:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

limited documentation regarding test material as well as method, but clear description of results.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

the study pre-dates the relevant guideline

Deviations:

yes

Remarks:

reduced observation period; extreme doses

GLP compliance:

no

Remarks:

Study predates relevant regulations

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Azomethinecolorant; Chromium complex, ammonium salt

Species:

rat

Strain:

other: Gassner

Sex:

male/female

Details on test animals or test system and environmental conditions:

no data

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

in water

Doses:

3200 - 6400 - 8000 - 10000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were treated once, observed for 7 days and necropsied. Observations were made on clinical signs, mortality as well as at necropsy.

Statistics:

not required

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

after 10000 mg/kg bw 1 animal died on day 4.

Clinical signs:

other: Immediately after application animals showed a squatting posture, accelerated, partly irregular, respiration and loss of hair in all groups. Symptom disappeared after several days in all groups.

Gross pathology:

at 10000 mg/kg: loss of perirenal fat and greenish discoloration of kidneys
at 8000 mg/kg: loss of perirenal fat.

Interpretation of results:

GHS criteria not met

Conclusions:

Even at the extreme doses above 3200 mg/kg bw only minor signs of toxicity were observed. The LD50 was clearly above 10000 mg/kg bw.

Executive summary:

After single oral gavage to rats at doses up to 10000 mg/kg the test material did cause only slight impairments of the general condition of the animals. One death was observed at the highest dose after 4 days. Clinical signs were limited to a squatting posture, accelerated, partly irregular respiration for few days after treatment. At necropsy loss of perirenal fat and discoloration of the kidneys was observed at 8000 mg/kg and above.

The LD50 was clearly above 10000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Quality of whole database:

2 reliable with restrictions (early study, outdated procedure)

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

No classification

The oral LD50 was clearly above 10000 mg/kg bw.