Registration Dossier
Registration Dossier
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EC number: 207-950-7 | CAS number: 502-69-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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:
- 6,10,14-trimethylpentadecan-2-one
- EC Number:
- 207-950-7
- EC Name:
- 6,10,14-trimethylpentadecan-2-one
- Cas Number:
- 502-69-2
- Molecular formula:
- C18H36O
- IUPAC Name:
- 6,10,14-trimethylpentadecan-2-one
- Details on test material:
- Purity: unknown
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, 6050 Offenbach / Main, Germany
- Weight at study initiation: male 3.25 kg, females 3.24 kg and 3.60 kg
- Housing: single in cage made of stainless steel with wire mesh walk floors, floor area: 40 cm * 51 cm
- Bedding: no bedding in the cages, saw-dust in the waste trays
- Identification: ear tattoo (= animal number)
- Diet: KLIBA 341, 4 mm; Firma Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland; about 130 g / animal / day
- Water: about 250 ml tap water / animal / day
- Acclimation period: at least 8 days before the beginning of the study; same housing conditions as during the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- applied once, eye not rinsed
- Observation period (in vivo):
- 72 hours
readings: 1, 24, 48 and 72 hours after application - Number of animals or in vitro replicates:
- 3
- Details on study design:
- - single application to the conjunctival sac of the right eyelid
- the substance was not washed out
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
animals 1 and 3: female, animal 2: male
cornea iris conjunctiva animal op ar red sw di 1 h 1 0 0 0 2 1 1 2 0 0 0 2 0 1 3 0 0 0 2 1 1 24 h 1 0 0 0 1 0 0 2 0 0 0 1 0 0 3 0 0 0 2 0 0 48 h 1 0 0 0 0 0 0 2 0 0 0 1 0 0 3 0 0 0 1 0 0 72 h 1 0 0 0 0 0 0 2 0 0 0 0 0 0 3 0 0 0 0 0 0 mean (24-72 h) 1 0,0 0,0 0,3 0,0 2 0,0 0,0 0,7 0,0 3 0,0 0,0 1,0 0,0 mean (24-72 h) 1-3 0,0 0,0 0,7 0,0 scale for scoring ocular lesions:
chemosis (SW) and cornea (OP, opacity-degree of density):
0 = none
1 = slight
2 = well-defined
3 = severe
4 = very severe
area of cornea involved (AR):
1 = 0 < AR < 1/4
2 = 1/4 <= AR < 1/2
3 = 1/2 <= AR < 3/4
4 = 3/4 <= AR
conjunctivae redness (red):
0 = normal
1 = slight
2 = well-defined
3 = severe
discharge (DI):
0 = normal
1 = slightly increased
2 = clearly increased
3 = distinctly increased
iris:
0 = normal
1 = circum-corneal injection
2 = iritis
calculation of the mean according to 83/467/EEC criteria: the 24, 48 and 72 hour readings are used for means of opacity, iris, redness and swelling
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