Propyl propionate

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 and there is no mention in the report on the status of compliance with the Principles of Good Laboratory Practice (GLP).

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propyl propionate

EC Number:

203-389-7

EC Name:

Propyl propionate

Cas Number:

106-36-5

Molecular formula:

C6H12O2

IUPAC Name:

propyl propanoate

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 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

Type of coverage:

occlusive

Preparation of test site:

other: intact, clipped skin

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4-hours

Observation period:

one hour, one day, 2 days, 3 days and 7 days

Number of animals:

3 males + 3 females

Details on study design:

The dose was applied to the clipped, intact skin of 6 rabbits under a gauze patch and is loosely covered with impervious sheeting and the animals restrained for the 4-hour contact period. Excess sample was removed after contact period.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

of 6 animals

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Remarks:

of 6 animals

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

A 4-hour application of 0.5 ml of n-propyl propionate to occluded rabbit skin resulted in no erythema, edema or other irritation on any of 6 rabbits. The dose sites remained unaffected through 7 days.

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 skin irritation

Executive summary:

In this study, three male and three female New Zealand White rabbits were dermally dosed with 0.5 ml of undiluted n-propyl propionate. The dose was applied to the clipped, intact skin of 6 rabbits under a gauze patch and was loosely covered with impervious sheeting and the animals restrained for the 4-hour contact period. Excess sample was removed after contact period. Skin reaction was scored, by the method of Draize, at one hour, one day, 2 days, 3 days and 7 days.

A 4-hour application of 0.5 ml of n-propyl propionate to occluded rabbit skin resulted in no erythema, edema or other irritation on any of 6 rabbits. The dose sites remained unaffected through 7 days. 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 skin irritation.