Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
other: no data
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test

Test animals

Species:
rat
Strain:
other: KFM_Han.wist.ar (outbred, SPF quality)
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: distilled water containing 4% carboxymethylcellulose sodium salt
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals per dose
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 1 (at day 3)
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 1 (at day 3)
Clinical signs:
Signs of toxicity related to dose level: Sedation, dyspnea, ataxia (males), curved body position, ruffed fur. The surviving animals recovered within 7
days.
Body weight:
no data
Gross pathology:
Lung: dark-red mottled, not collapsed
Intestines/stomach: meteorism filled with yellowish contents
Other findings:
Killed animals
Lung: dark-red mottled (in 2 animals)

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
LD50 >5000 mg/kg bw