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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Additional information

Justification for classification or non-classification

No classification

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