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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977
Reference Type:
other: Published secondary source
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Five dose acute toxicity study
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Multi constituent substance
EC Number:
916-604-0
IUPAC Name:
Multi constituent substance
Details on test material:
No information on test item available

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 1% methylcellulose in water
Doses:
100, 1000, 4000, 8000 and 16000 mg/kg bw
No. of animals per sex per dose:
Four animals per sex per dose
Control animals:
yes
Details on study design:
The test item was administered to groups of 4 male and 4 female rats at dose levels of 100, 1000, 4000, 8000 and 16000 mg/kg bw. The test item was prepared as 10 to 40 (w/v) suspensions in 1% methylcellulose in water. Animals treated with the vehicle alone served as controls. All animals were observed for a period of 14 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 8 000 - <= 16 000 mg/kg bw
Based on:
test mat.
Mortality:
Two male rats and one female rat from the highest dose group died. Death occurred from within two to three hours of treatment.
Clinical signs:
other: Lethargy, piloerection, decreased respiratory rate and hunched posture were observed shortly after dosing. These signs were accompanied by increased salivation and diuresis in rats dosed at 8.0 and 16.0g/kg bw and by diarrhoea and ptosis in rats dosed at
Gross pathology:
Autopsy of the rats from the highest dose group that died revealed pallor of the liver, kidneys ans spleen. Terminal autopsy findings were within normal limits.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the LD50 of the test item was reported to be between 8000 and 16000 mg/kg bw. The substance is not classified.
Executive summary:

Under the experimental conditions, the LD50 of the test item was reported to be between 8000 and 16000 mg/kg bw. The substance is not classified.