Registration Dossier
Registration Dossier
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EC number: 262-475-2 | CAS number: 60857-05-8
Toxicological information
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: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
Test material
- Reference substance name:
- Tetrahydro-4-methylene-2-(2-methyl-1-propenyl)-2H-pyran
- EC Number:
- 262-475-2
- EC Name:
- Tetrahydro-4-methylene-2-(2-methyl-1-propenyl)-2H-pyran
- Cas Number:
- 60857-05-8
- Molecular formula:
- C10H16O
- IUPAC Name:
- 4-methylidene-2-(2-methylprop-1-en-1-yl)oxane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Age of the animals at day 0: 4 - 5 months
Acclimatization for at least 5 days before application.
Animal identification: via ear tattoo
Body weight(s) on day 0: 3.15 - 3.68 kg
The animals were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity between 30 - 70%. The day/night rhythm was 12 h dark and 12 h light.
The animals were housed singly in stainless steel wire mesh cages with grating (floor area: 3000 cm2).
The rabbits were offered a standardized animal laboratory diet (ca. 130 g/animal/day) as well as tap water ad libitum.
- Source: Centre Lago S. A., France
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye of same animal
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Before the beginning of application both eyes were investigated for signs of pre-existing irritation. Only animals with intact cornea and conjunctiva were used.
The body weights were determined just before application of the test substance and after the least reading.
The test substance was applied as a single dose to the conjunctival sac of the right eyelid.
A check for any dead or moribund animal was made twice each working day and once daily at weekends and on public holidays.
REMOVAL OF TEST SUBSTANCE
- Washing: yes; 3 - 6 ml of hand-warm tap water for 1 - 2 min using a syringe with a blunt probe.
- Time after start of exposure: 24h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritant / corrosive response data:
- Injected scleral vessels in a circumscribed area or circular were noted in all animals during the observation period.
Applicant's summary and conclusion
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