Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Early study conducted according to scientifically accepted method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
10 female Wistar rats were dosed by gavage with a single dose of C.I. Direct Blue 264. Animals were observed for 14 days and number of death and alive animals were recorded.
GLP compliance:
no
Test type:
other: Limit test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Doses:
5
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Single dose of 5000 mg/kg bw was used. 2/10 animals died during the 14 day observation period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
In a limited early acute oral toxicity study in female rats. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.
Executive summary:

In a limited early acute oral toxicity study in female rats. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.