Registration Dossier
Registration Dossier
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EC number: 927-786-6 | CAS number: 1180051-47-1
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
- Study period:
- 1996
- 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 ioxaglique 286
- IUPAC Name:
- Acide ioxaglique 286
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- "286 intermediate" is the precursor of the compound "286" known as "ioxaglic acid". "286 intermediate"and "286" have the same chemical struture except that "286 intermediate" is the triethylammonium salt of "286". "286intermediate" can have a slightly higher impurity content (less than 2% with no impurity detected above 1%) than 286. It is not believed that these minor differences may alter dramatically the toxicity profile established for "286". It is also of importance to know that "286" is a well-characterized pharmaceutical active substance, authorised in drug product called Hexabrix.
Therefore, the data on "286" are considered fully relevant to assess the toxicity profile of "286 intermediate".
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 0.3 ml water
- Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48 and 72 h after coverage removal
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 5*5 cm
- Type of wrap if used: stretch band
REMOVAL OF TEST SUBSTANCE
- Substance removal: aborbing paper with water
- Time after start of exposure: 4h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- ca. 1
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: slight erythema
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- ca. 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- results's interpretation upon directive 67/548: substance is not skin irritating.
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