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Registration Dossier
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EC number: 240-886-8 | CAS number: 16867-03-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06.10.2003 - 29.01.2004
- 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 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Age and body weigh : 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: 17.8 - 21.0°C), a relative humidity of 30-70% (actual range: 21 - 73%) and 12 hours artificial fluorescent light and 12 hours darkness per day. Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.
Accommodation:
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
- Controls:
- other: The other eye remained untreated and served as the reference control.
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean, animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: mean, animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean, animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- other: mean, animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean, animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: mean, animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean, animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- other: mean, animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean, animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: mean, animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean, animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- other: mean, animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
Applicant's summary and conclusion
- 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 should be classified as: irritating to eyes (Class 2).
- 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 eye irritation. - Executive summary:
Acute eye irritation/corrosion study with A 132 in the rabbit.
The study was carried out based on the guidelines described in: "Acute Toxicity - Eye irritation", OECD No.405 (2002); EC Commission Directive 92/69/EEC, B.5, "Acute Eye lrritation/Corrosion" (1992); US EPA, OPPTS 870.2400, Acute Eye Irritation, (1998) and JMAFF guidelines (2000).
Single samples of approximately 60 mg of A 132 (a volume of approximately 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours, and 7 and 14 days after instillation.
Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae.
The corneal injury consisted of opacity (maximum grade 1) and epithelial damage (maximum 50% of the corneal area). The corneal injury had resolved within 48 or 72 hours, or 7 days in the respective animals. lridial irritation grade 1 was observed in one animal 1 and 24 hours after instillation. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 14 days in all animals.
Remnants of the test substance were noted in the eye of all animals 1, 24 and 48 hours after instillation.
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 should be classified as: irritating to eyes (Class 2).
- 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 eye irritation.
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