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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
18 to 31 August, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
rac-5-Amino-N-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamic acid
EC Number:
601-093-6
Cas Number:
111453-32-8
Molecular formula:
C11 H11 I3 N2 O5
IUPAC Name:
rac-5-Amino-N-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamic acid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3/sex
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Gross pathology:
no findings ???

Any other information on results incl. tables

 


no clinical or macroscopic pathological signs

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Since LD50> 2000 mg/kg, there is no classification required.
Executive summary:

The single oral administration of the test substance (ZK 39211) to male and female rats at a dose of 2000 mg/kg was tolerated without any compound-related clinical or macroscopic pathological signs. The acute oral toxicity (LD50) of ZK 39211 in rats is above 2000 mg/kg body weight.