Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

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

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3/sex/dose

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Reversibility:
other: not relevant
Other effects:
The test substance was tolerated without any local skin irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Since the test substance was tolerated without any local skin irritation, classification is not 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 in all male rats. One male rat died. The female animals were without any clinical signs. The test substance was tolerated without any local skin irritations. (Schering AG, report no: X192, 1997-01-08)