Registration Dossier
Registration Dossier
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EC number: 268-597-2 | CAS number: 68130-55-2
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate
- EC Number:
- 234-392-1
- EC Name:
- Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate
- Cas Number:
- 11138-60-6
- IUPAC Name:
- 2,2-bis[(octanoyloxy)methyl]butyl decanoate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole du Val de Selle, 80160 Prouzel, France
- Weight at study initiation: mean weight of 2.6 ± 0.2 kg
- Housing: individuallly
- Diet: ad libitum with a certified pellet diet "Rabbits sustenance ref. 112 C" (U.A.R., 91360 Villemoisson-sur-Orge, France).
- Water: free access to tap water fil tered by a 0.22 micron filter membrane (Societe Millipore, 78140 Velizy, France) and contained in water bottles
- Acclimation period: for at least 5 days during which they were observed daily
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20% relative humidity
- Photoperiod (hrs dark / hrs light): 12 hours of light/12 hours of dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml of the test substance in its original form was instilled into the conjunctival sac of the left eye of 3 male New Zealand White rabbits.
- Duration of treatment / exposure:
- single instillation; eyes were not rinsed after instillation of the test substance
- Observation period (in vivo):
- 24, 48 and 72 hours after the instillation.
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No ocular reactions were noted in all the animals.
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