Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
No toxicology data are available on the substance "95SA", also called "ioxitalamic acid, ammonium salt". However, data are available on the substance "95" (also called "ioxitalamic acid") and, therefore, the Applicant proposes to rely on these data. The chemical structure of both substances is the same, but "95SA" is an ammonium salt of "95". The quality (purity) of both substances is also comparable as "95SA" has a slightly higher total impurity content than "95" (total impurities < 2% in "95SA", while < 1% in "95"). It is not believed that these 2 minor differences may alter dramatically the toxicity profile established for "95". It is also of importance to know that "95" is a well-characterized pharmaceutical active substance, authorised in drug product called Telebrix.
Therefore, the data on "95" are considered fully relevant to assess the toxicity profile of "95SA".

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.5 g substance humidified with 0.2 ml water
Duration of treatment / exposure:
4h
Observation period:
1h, 24h, 48h and 72 h
Number of animals:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
ca. 0
Max. score:
0
Remarks on result:
other: no effect observed after 72h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h
Score:
ca. 0
Max. score:
0
Remarks on result:
other: no effect observed after 72h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
upon directive 67/548, substance acide ioxitalamique 95 is not irritating or corrosive for skin.