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Registration Dossier
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EC number: 615-749-4 | CAS number: 72291-30-6
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-01-11 to 2005-06-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- June 16, 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24, 2000 as this in lin line with OECD 405
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
Test material
- Reference substance name:
- 2-cyano-2-methyl-propanoic acid methyl ester
- EC Number:
- 615-749-4
- Cas Number:
- 72291-30-6
- Molecular formula:
- C6 H9 N O2
- IUPAC Name:
- 2-cyano-2-methyl-propanoic acid methyl ester
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 5 months
- Weight at study initiation: 3.07 kg - 3.72 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet: Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod: 12 h light (6.00 a.m. - 6 .00 p.m .) 12 h darkness (6.00 p .m. - 6.00 a.m .)
IN-LIFE DATES: From: November 02, 2004 To: February 15, 2005
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 14 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Rinsing of the eye: About 24 hours after application of the liquid test substance the treated eye of the animal was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
The ocular recations were assessed approximately 1, 24, 48 and 72 hours after application and then in weekly intervals until day 14.
Before the beginning of application both eyes were investigated for signs of pre-existing irritation. Only animals with intact cornea and conjunctiva were used.
Body weight determination: Just before application of the test substance and after the last reading.
Route of application: The test substance was applied in a single dose to the conjunctival sac of the right eyelid.
Check for dead or moribund animals twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.9
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on this results the substance is considered as irritating.
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