Registration Dossier
Registration Dossier
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EC number: 240-886-8 | CAS number: 16867-03-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06.10.2003 - 27.01.2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-aminopyridin-3-ol
- EC Number:
- 240-886-8
- EC Name:
- 2-aminopyridin-3-ol
- Cas Number:
- 16867-03-1
- Molecular formula:
- C5H6N2O
- IUPAC Name:
- 2-aminopyridin-3-ol
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age and body weight: Animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.
Identification: Earmark
Conditions: Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0°C (actual range: 19.6 - 22.3°C), a relative humidity of 30-70% (actual range: 37 - 59%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Accomodation: lndividually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g. per day.
Water: Free access to tap-water.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Amount / concentration applied:
- 0.5 grams test substance was moistened with water (Milli-U)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Based on these results and according to the:
- OECD Harmonized lntegrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), A 132 does not have to be classified for skin irritation.
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), A 132 does not have to be classified and has no obligatory labelling requirement for skin irritation. - Executive summary:
Primary skin irritation/corrosion study with A 132 in the rabbit (4-hour semiocclusive application).
The study was carried out based an the guidelines described in: OECD No.404, "Acute Dermal lrritation/Corrosion" (2002); EC Commission Directive 92/69/EEC, B.4, "Acute Toxicity - Skin irritation" (1992); US EPA, OPPTS 870.2500, Acute Dermal Irritation (1998) and JMAFF, Japanese Test Guidelines (2000).
Three rabbits were exposed to 0.5 grams of A 132, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.
No skin irritation was caused by 4 hours exposure to A 132.
Brownish staining of the treated skin by the test substance was observed during the observation period, which did not hamper the scoring of the skin reactions.
Based on these results and according to the:
- OECD Harmonized lntegrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), A 132 does not have to be classified for skin irritation.
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), A 132 does not have to be classified and has no obligatory labelling requirement for skin irritation.
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