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Registration Dossier
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EC number: 245-224-1 | CAS number: 22794-26-9
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:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Protocol published at official journal of French Republic (Official journal of 24 october 1984)
- Version / remarks:
- Protocol has some similarities with OECD guideline 405.
- Deviations:
- not specified
- Principles of method if other than guideline:
- Unique instillation of a precise dose of the product in right conjunctival sac of 6 animals, left eye is acting as control.
Animals are observed at 1 hour, D1, D2, D3 up to D7.
If no reaction is visible at D2, the observation is stopped at D3.
Calculation of the ocular index after summing according to the scale in the following charts for each animal on the cornea, iris, cunjunctive areas. - GLP compliance:
- no
- Remarks:
- GLP not mandatory at this date
Test material
- Reference substance name:
- Dodecyl 5-oxo-L-prolinate
- EC Number:
- 245-224-1
- EC Name:
- Dodecyl 5-oxo-L-prolinate
- Cas Number:
- 22794-26-9
- Molecular formula:
- C17H31NO3
- IUPAC Name:
- dodecyl 5-oxo-L-prolinate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 6 mâle New-Zealand breed rabbits with perfect eyes state with an average weight about 2.5, 3 Kgs from : Elevage Scientifique D es Dombes (C.E.G.A.V.).
Aniamls are placed in sanitary quarantine during at least one week prior to every experimentation.
The animals are housed in individual plastic standardised cages.
The premises are under air pressure with renewing cycles of 3000 cubic meter/ hour.
The illumination period is electronically regulated providing 12 hours of daylight every day.
Water is supllied "ad libidum"
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 1 hour after treatment until Day-7
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed
TOOL USED TO ASSESS SCORE: ophtalmoscop
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.28
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.28
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- not specified
- Irritant / corrosive response data:
- At 48h, the following results are obtained :
- A corneal opacity mean score >=1.0 was observed in 3 animals
- A conjunctival redness (enanthema) mean score >= 2.0 was observed in all animals
- A conjunctival oedema (chemosis) mean score >= 2.0 was observed only in 1 animal
Effects are fully reversible within on Day-5
The OI (Ocular Index) max has a value of 40, whereas the O.I.48h has a value of 12.66
According to criteria set in the official journal of French Republic (Official journal of 24 october 1984) the test item Lauryle Pidolate is considered as irritating.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The product examined in ocular instillation according to the described protocol, in normal use conditions, undiluted, provokes specific significant medium value irritative injuries of the ocular mucous membrane.
Under tests conditions, the test item Lauryle Pidolate is considered as irritating and required a classification as Eye. Irrit. cat.2, H319 based on redness of conjonctiva according to CLP regulation.
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