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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data originally submitted as part of the 67/548/EEC notification package.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 96/54/EG, B.1tris (Akute-toxische-Klassen-Methode); OECD 423 (1996)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Test animals

Species:
rat
Strain:
other: HanIbm:WIST (SPF)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Polyethylglykol, PEG 300
No. of animals per sex per dose:
3
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0 Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
other: No deaths occurred during the study. Weak activity was observed in one male animal from 1 to 5 h after the administration and persisted on day 2. Slight dyspnea was then additionally observed on days 3-4. One male animal showed a marginal loss of body
Gross pathology:
The animals were sacrificed after the test and macroscopically examined. No clinical signs were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No effects were seen at > 2000 mg/kg. The substance is not classified.
Executive summary:

No effects were seen at > 2000 mg/kg. The substance is not classified.