Registration Dossier
Registration Dossier
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EC number: 480-240-4 | CAS number: 185257-07-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Name of test substance: MGDN
Chemical name: Propanenitrile, 2- [Bis (Cyanomethyl) - Amino] -, (+-)
Substance number: 96/83
Batch number: GRE 3038/F 535
Degreee of purity/content: 97.9% (HPLC)
Date of manufacturing: September 09 - 11, 1994
Physical state/appearance: powder, beige.
Storage conitions: Room temperature.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: HSDIF: NZW
- Details on test animals or tissues and environmental conditions:
- Animal supplier: Harlan Winkelmann GmbH (Interfauna - United Kingdom)
Age: Young adult animals.
Identification: Ear Tattoo.
Room Temperature/relative humidity: Animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20-24°C for temperature and of 30-70% for relative humidity. There were no deviations from these ranges which influenced the results of the study.
Day/Night rhythm: 12h / 12h (6.00 a.m. - 6.00 p.m./6.00 p.m. - 6.00 a.m.)
Type of cage: stainless steel wire mesh cages with grating.
Floor area: 3000 cm2.
No. of animals per cage: single housing.
Drinking water: about 250 ml tap water per animal per day.
Diet: Kliba-Labordiät 341, Klingentalmuehle AG Kaiseraugst, Switzerland. About 130 g per animal per day.
Acclimatization period: at least one week.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- 0.1 ml bulk volume (about 41 mg of the comminuted test substance)
- Duration of treatment / exposure:
- Exposure: 24 hours
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 (2 females, 1 male)
- Details on study design:
- Application: Single application to the conjunctival sac of the right eyelid; the substance was washed out with tap water about 24 hours after application (before 24 hour reading).
Readings: 1, 24, 48, 72 hours after application.
Mortality: A check for any dead or moribund animals was made twice each workday and once on saturdays, sundays and on public holidays.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h, 48h and 72h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24h, 48h and 72h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24h, 48h and 72h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24h, 48h and 72h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h, 48h and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
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