Registration Dossier
Registration Dossier
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EC number: 926-540-5 | CAS number: 1174510-13-4
Skin irritation / corrosion
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:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- acide ioxitalamique
- IUPAC Name:
- acide ioxitalamique
- 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".
Constituent 1
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.
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