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Administrative data

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:
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 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:
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.
Body weight:
no data
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

Additional information

Justification for classification or non-classification

No classification

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