Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Eye irritation potential was examined by placing 0.1 ml of primary amyl acetate into the eye of 6 rabbits. Eyes were examined at various times for 7 days after dosing.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 2-methylbutyl acetate and pentyl acetate
EC Number:
908-918-1
Molecular formula:
Unspecified
IUPAC Name:
Reaction mass of 2-methylbutyl acetate and pentyl acetate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals are maintained on appropriate commercial diet and municipal water. Both are available ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 ml and 0.01 ml
Duration of treatment / exposure:
24 hr
Observation period (in vivo):
Eyes are scored by the attached system at one hour, approximately 6 hours, one day, 2 days and 3 days after dosing.
Number of animals or in vitro replicates:
Six eyes are dosed per test volume.
Details on study design:
Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid). The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored by the attached system at one hour, approximately 6 hours, one day, 2 days and 3 days after dosing. Additional readings are made if necessary. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Remarks on result:
other: 0.1 ml test substance applied
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Remarks on result:
other: 0.1 ml test substance applied
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.4
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 0.1 ml test substance applied
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 0.1 ml test substance applied
Irritant / corrosive response data:
In 6 rabbit eyes, doses of 0.1 ml produced minor conjunctival irritation, but no corneal injury or iritis. Slight conjunctival irritation persisted in one eye through 3 days. At 7 days, all eyes were normal. Instillation of 0.01 ml resulted in slight conjunctival irritation in 6 eyes within one hour. Four
eyes remained irritated at 6 hours, but only one had slight conjuncival irritation at 24 hours. Very slight irritation persisted in this eye through 3 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met