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Registration Dossier
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EC number: 279-979-3 | CAS number: 82493-14-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23. Feb - 3 March 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed and reported study equivalent to OECD guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 4 days acclimatisation
- Qualifier:
- according to guideline
- Guideline:
- other: proposed guidelines of the US EPA paragraph 163.81-4 "Primary Eye Irritation Study", Federal Register, Vol. 43, No. 163, Aug. 22, 1978
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- performed before GLP guidelines
Test material
- Reference substance name:
- N-(2-ethoxyphenyl)-N'-(4-isododecylphenyl)oxamide
- EC Number:
- 279-979-3
- EC Name:
- N-(2-ethoxyphenyl)-N'-(4-isododecylphenyl)oxamide
- Cas Number:
- 82493-14-9
- Molecular formula:
- C28H40N2O3
- IUPAC Name:
- N-(2-ethoxyphenyl)-N'-[4-(10-methylundecyl)phenyl]ethanediamide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Füllinsdorf, Switzerland
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.3-3.0 kg
- Housing: individually in stainless steel cages
- Water (e.g. ad libitum): ad libitum
- Diet: Standard Kliba 341 Rabbit Maintenance Food, Klingentalmühle AG, Switzerland
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2°C
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- no washing performed
- Observation period (in vivo):
- 24, 48, 72 h, 4, 7, 14 and 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- A single dose of the test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and th lids were gently closed for a few seconds. The right eye remained untreated and served as a control. In 3 out of 6 rabbits approx. 30 seconds after treatment the treated eye was flushed with physiological saline for about one minute.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 0
- Max. score:
- 80
- Remarks on result:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 0
- Max. score:
- 10
- Remarks on result:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h/48h/72h
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- other: no effects
- Irritant / corrosive response data:
- no effects observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- With reference the reported scores (absence of effects) Hostavin 3206 does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
Hostavin 3206 was tested for its eye irritant properties in 6 New Zealand White rabbits.The study was performed equivalent to OECD Guideline 405.No effects were observed in all animals 24, 48 and 72 hours after application.
With reference the reported scores (absence of effects) Hostavin 3206 does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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