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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: the study is performed in 1980 similar to the guideline of nowadays, GLP not menioned

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Single dose administered; observation period 14 days; 5 male and 5 female rats tested.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
Macrolex Yellow FB 64559
Yellow powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No deaths, no clinical signs, no gross pathological findings at the end of the 14 days observation period.

Applicant's summary and conclusion

Executive summary:

After single dosing of 5 male and 5 female rats with 5000 mg/kg no deaths, no clinical signs and no gross pathological findings were reported.