Registration Dossier
Registration Dossier
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EC number: 234-294-9 | CAS number: 11071-47-9
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:
- other: According to guideline study (OECD 405)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Dodecene, branched
- EC Number:
- 306-479-5
- EC Name:
- Dodecene, branched
- Cas Number:
- 97280-83-6
- Molecular formula:
- C12 H24
- IUPAC Name:
- Dodecene, reaction product of butene
- Details on test material:
- - Name of test material (as cited in study report): Isododecene
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Savo; med. Versuchstierzuchten GmbH, 7964 Kisslegg
- Weight at study initiation: Animal 1 (male) - 3.22 kg; Animal 2 (female) - 3.33 kg; Animal 3 (female) - 3.61 kg
- Housing: 1 animal per cage, in cages made of stainless steel with wire mesh walk floors
- Diet (e.g. ad libitum): about 130 g per animal per day (KLIBA 341)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days (same housing conditions as during the study)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
There were no deviations from these ranges which influenced the results of the study
Animal identification: ear tattoo
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted
Application: single application to the conjunctival sac of the right eyelid
- Duration of treatment / exposure:
- The test substance was not washed out
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- SCORING SYSTEM: Draize score
Readings: 1 h, 24 h, 48 h and 72 h after application
(For calculation of the means of opacity, iris, redness and swelling only the readings of 24, 48 and 72 hours are used)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 hours
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 hours
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0.4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
Any other information on results incl. tables
No need for labelling according to Directive 67/548 and GHS (UN, 2007)
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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