Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD 405 guideline, but predating GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
yes
Remarks:
no observations at the 48 and 72 hours observation times.
GLP compliance:
no
Remarks:
Study performed around/just before the time GLP was introduced in Europe, but internal QA statement.

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
EC Number:
700-927-7
Molecular formula:
C17H30O2
IUPAC Name:
Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): PM 968
- Physical state: clear colourless liquid
- Storage condition of test material: no data available

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: commercial supplier
- Age at study initiation: at least 8 weeks
- Weight at study initiation: 2.29 - 2.76 kg
- Housing: individually housed in cages with wire mesh floors.
- Diet: free access to a certified pelleted commercial rabbit diet
- Water: free access to tap water
- Acclimation period: no data avaiable

ENVIRONMENTAL CONDITIONS
- No data available

Test system

Vehicle:
other: Tween 80
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): undiluted and 50% test substance in Tween 80

Duration of treatment / exposure:
One single application.
Observation period (in vivo):
24 hours
Number of animals or in vitro replicates:
4 males
Details on study design:
STUDY DESIGN
Each test substance is applied to one eye of each of a group of rabbits and the subsequent responses assessed by macroscopic observation and by
measurement of corneal swelling. Observations are continued at intervals up to a maximum of 22 days after treatment or, if sooner, until the eyes are
considered to be of normal appearance.

TREATMENT
Only one eye of each animal is treated. Substances are applied to the conjunctival sac formed by gently pulling the lower eyelid away from the eyeball. After treatment the eye is closed and the eyelids released. Initially, each substance to be tested is applied to one rabbit per group.
If, 24 hours later, the responses in these rabbits are not unacceptably high then the remaining rabbits are treated.

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
The eyes are examined with the aid of a hand-held torch. Conjunctival responses are assessed 15 minutes after treatment. Corneal thickness is measured with a slit lamp 24 hours after treatment and thereafter at daily intervals until the thickness has returned to its pretreatment value. Corneal, conjunctival and iridial responses are assessed 24 hours after treatment and thereafter at specified daily intervals up to 22 days after treatment. Assessments are stopped earlier if the eye has returned to normal.
The irritation was assessed according to OECD 405.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #2, #3 and #4
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: undiluted test substance.
Irritation parameter:
iris score
Basis:
animal: #2, #3 and #4
Time point:
other: 24 hours
Score:
0
Max. score:
2
Remarks on result:
other: undiluted test substance.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #2, #3 and #4
Time point:
other: 24 hours
Score:
0
Max. score:
3
Remarks on result:
other: undiluted test substance.
Irritation parameter:
chemosis score
Basis:
animal: #2, #3 and #4
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: undiluted test substance.
Irritant / corrosive response data:
All 4 animals showed very slight redness of the conjunctivae 15 minutes after the substance was installed in the eye.
50% Karanal in Tween 80: One rabbit was treated. The treated eye subsequently showed a moderate conjunctivitis characterised by marked oedema and slight
erythema. The cornea was unaffected by treatment at the 24 and 48 hours observation time. The conjunctival reaction rapidly lessened in intensity and the effects were fully reversible within 48 hours.
Undiluted Karanal: Three rabbits were treated. The treated eyes of all 3 rabbits showed only a slight transient conjunctivitis. The corneas were unaffected by treatment at the 24 hours observation time.
Remark: When at 24 hours no irritation was observed, no further observations were described.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was tested in an eye irritation test in rabbits according to OECD 405 guideline. The substance is not considered to be irritating to eyes.
Executive summary:

The substance was tested (0.1 mL) in an eye irritation test in rabbits according to OECD 405 guideline. Three rabbits were treated. The treated eyes of all 3 rabbits showed only a slight transient conjunctivitis. The corneas were unaffected by treatment at the 24 hours observation time. Although the observations were not performed at the 48 and 72 hours observation times, all animals showed a slight transient effect, disappearing within 24 hours. As the substance is a liquid it is not expected to affect the eye later on in time.

Therefore, the substance is not considered to be irritating to eyes.