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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: dermal
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Feb to May 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): rac-5-amino-N-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamic acid (ZK 39.211)
- Lot/batch No.: 20020004

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Duration of exposure:
24 hours
Doses:
200 and 2000 mg/kg bw
No. of animals per sex per dose:
3/sex/group
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Clinical signs: retarded respiration, gasping breathing, eyelid closure, unconsciousness in 1/3 male rats, this rat died on day 2; apathy in 2/3 male rats. The female animals were without any clinical signs.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Since LD50> 2000 mg/kg, there is no classification required.
Executive summary:

The single dermal administration of Tamip monoamide to male and female rats in the doses of 200 and 2000 mg/kg results at high dose in clinical signs (retarded respiration, gasping breathing, eyelid closure, unconsciousness in 1/3 male rats; apathy 2/3 male rats). One male rat died. The female animals were without any clinical signs. LD50 > 2000 mg/kg