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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:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent or similar to OECD TG 405 and there is no mention in the report on the status of compliance with the Principles of Good Laboratory Practice (GLP).
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): n-propyl propionate
- Physical state: colorless, transparent, low viscosity liquid
- Analytical purity: 100%
- Lot/batch No.: 51-535; 52-19 (15RLRX51)
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: assumed to be in-house
- Age at study initiation: young adults
- Weight at study initiation: 2.0 - 3.0 kg
- Fasting period before study: no
- Housing: assumed to be individually housed
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
approximately 1 second
Observation period (in vivo):
one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing
Number of animals or in vitro replicates:
3 males + 3 females
Details on study design:
The dose was instilled into the lower conjunctival sac of one eye per animal. The eyelids were held together for one second. The eyes were scored by the Draize system at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Fluorescein (2%) staining was 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
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 ours
Score:
0.4
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Instillation of 0.1 ml of sample into rabbit eyes resulted in minor (transient) corneal injury (opacity) in one of 6 animals. Iritis was apparent in 5 eyes and moderate conjunctival irritation, with a substantial amount of discharge, developed in all 6 rabbits. By 48 hours, 5 eyes had a normal appearance. One eye had only slight conjunctival redness. All 6 eyes were healed after 72 hours.
Other effects:
none

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for eye irritation.
Executive summary:

In this three Male and three female New Zealand White rabbits were topically dosed with 0.1 ml of undiluted n-propyl propionate. The dose was instilled into the lower conjunctival sac of one eye per animal. The eyelids were held together for one second. The eyes were scored by the Draize system at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Fluorescein (2%) staining was used to determine corneal injury before dosing and at readings after one day.

Instillation of 0.1 ml of sample into rabbit eyes resulted in minor (transient) corneal injury (opacity) in one of 6 animals. Iritis was apparent in 5 eyes and moderate conjunctival irritation, with a substantial amount of discharge, developed in all 6 rabbits. By 48 hours, 5 eyes had a normal appearance. One eye had only slight conjunctival redness. All 6 eyes were healed after 72 hours.Under the conditions of the study, as the dermal LD50 of n-propyl propionate is in excess of 14000 mg/kg, hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for eye irritation.