Registration Dossier
Registration Dossier
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EC number: 700-002-8 | CAS number: 1333483-07-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Version of April 24, 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-[(1E)-2-(2,4-diamino-6-hydroxypyrimidin-5-yl)diazen-1-yl]-5-methylbenzene-1-sulfonic acid
- EC Number:
- 700-002-8
- Cas Number:
- 1333483-07-0
- Molecular formula:
- C11H12N6SO4
- IUPAC Name:
- 2-[(1E)-2-(2,4-diamino-6-hydroxypyrimidin-5-yl)diazen-1-yl]-5-methylbenzene-1-sulfonic acid
- Details on test material:
- Purity; 95.6 % w/w
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- single treatment
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and in weekly intervals until day 14.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
Any other information on results incl. tables
The following test item-related clinical observations were recorded during the course of
the study:
· Very slight to well-defined erythema (grade 1-2)
The cutaneous reactions were reversible in one animal within 72 hours and in another animal within 7 days after removal of the patch. In the third animal very slight erythema was still observed on day 14 (study termination).
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 2.0 and 1.0 for erythema and 0.0, 0.0 and 0.0 for edema.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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