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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Principles of method if other than guideline:
Method: other: Federal Register, 1978, 43, 37355-6, a standard acute method.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Details on test material:
EDA, EO + PO
Lot TB11170-841
Based on producers products specs information from the producer (not available in the report) the test material was 70–90% PO and 10–30% EO and has a Molecular Mass of (average Mn = 280 g/mol)

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000, 2500, 1250, 650
No. of animals per sex per dose:
6

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw

Any other information on results incl. tables

MORTALITY:  
- Time of death: Not documented
- Number of deaths at each dose: 1 male and 1 female in top does (5000 mg/kg).

CLINICAL SIGNS:  
Diarrhea and slight tremors were observed in the rat that subsequently died. All surviving rats appeared healthy and gained weight during the 2-week observation period.
 

NECROPSY FINDINGS: none
POTENTIAL TARGET ORGANS: not identified
SEX-SPECIFIC DIFFERENCES: not reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 of >5000 mg/kg: no EU classification for acute oral toxicity.