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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study; summary; no GLP;

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Remarks:
pre dates GLP regulation
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fettgelb 3G
IUPAC Name:
Fettgelb 3G

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous starch
Details on oral exposure:
Apllication: suspension in aqueous starch slurry
Concentration: 25 %
Dose: maximum technically feasible
Doses:
15000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Fasting: 12 h before treament
- Administration: single gavage
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: no data


Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 15 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD 50 is expected to be greater then 15000 mg/kg bw.
Executive summary:

The test item was suspended at a concentration of 25 % in an aqueous starch slurry and administered once via gavage to 10 female Wistar rats. Animals weighed 102 - 113 g and were fasted 12 hours before treatment. Rats were observed for 7 days.

Results:

No animal died at the maximum feasible dose of 15 000 mg/kg bw. The LD 50 is expected to be greater then 15000 mg/kg bw.