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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No information on the guideline.
GLP compliance:
not specified
Remarks:
No information on the publication
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
No data

Test animals

Species:
mouse
Strain:
Swiss
Sex:
not specified
Details on test animals and environmental conditions:
Supplier: C.E.R Janvier, Laval, FranceAge: 6 weeksRats were caged singly in plastic cage and housed in fully air-conditioned rooms with temperature = 19-23°C and humidity continuosly recorded. Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hours period. Feeding: ad libitum coomercial pellet diet (A04, SAFE, Villemoisson, France)Drinking water: tap water ad libitumAcclimatization: one week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
doubly distilled
Details on oral exposure:
The tested substance was dissolved in waterPositive control: DAB dimethylaminoazobenzene dissolved in olive oilNegative control: water and oil
Doses:
20, 200 and 1000 mg/kg bw
No. of animals per sex per dose:
7 animals per group
Control animals:
no
Details on study design:
Mice were given a double dose of tartrazine, 24 h apart and were killed 24 hours after the last dosing.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Mortality:
No mortality occurred
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The tested item was found to be non-toxic for oral exposure with a LD50 > 1000 mg/kg bw.
Executive summary:

The acute oral toxicity test of Acid Yellow 23 in mice showed a LD50 value was > 1000 mg/kg.