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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:
2008
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

Constituent 1
Chemical structure
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

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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