Pentyl propionate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study methodology followed was according to OECD TG 404 and the report contains sufficient information to permit a meaningful evaluation of study results

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:

1988

Report date:

1988

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:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Pentyl propionate

EC Number:

210-852-7

EC Name:

Pentyl propionate

Cas Number:

624-54-4

Molecular formula:

C8H16O2

IUPAC Name:

pentyl propanoate

Details on test material:

- Name of test material (as cited in study report): UCAR N-pentyl propionate
- Molecular weight: 144.2
- Physical state: clear colourless, low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: BRRC Sample No. 51-19
- Storage condition of test material: at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in-house
- Age at study initiation: adults
- Weight at study initiation: 2.0-3.0 kg
- Housing: group housed
- Diet (e.g. ad libitum): appropriate commercial diet, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped intact skin

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml undiluted UCAR n-pentyl propionate

Duration of treatment / exposure:

4 hours

Observation period:

one hour, 1 day, 2 days, 3 days and 7 days

Number of animals:

3 male + 3 female rabbits

Details on study design:

New Zealand White rabbits were dosed topically with 0.5 ml of UCAR n-pentyl propionate to the clipped intact skin of the trunk under a gauze patch and loosely covered with impervious sheeting. The animals were restrained for the 4-hour contact period. Excess samples were removed after the contact period and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days and 7 days with perios extended upto 14 days depending on the skin recations noted.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

over 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

over 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

No signs of erythema and edema were noted in any of the exposed animals

Other effects:

One female rabbit was found dead on day 7 with no apparent signs of irritation, concluded to be not treatment related

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, UCAR n-pentyl propionate would not be be classified as a skin irritant according to the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures

Executive summary:

In this study, the skin irritation potential of undiluted UCAR n-pentyl propionate was evaluated on three male and three female New Zealand White rabbits over a 4 hour contact period. The animals were dosed topically with 0.5 ml of UCAR n-pentyl propionate to the clipped intact skin of the trunk under a gauze patch and loosely covered with impervious sheeting. The animals were restrained for the 4-hour contact period. Excess samples were removed after the contact period and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days and 7 days with perios extended upto 14 days depending on the skin recations noted. No signs of erythema and edema were noted in any of the exposed animals. One female rabbit was found dead on day 7 with no apparent signs of irritation, concluded to be not treatment related. Under the conditions of the study, UCAR n-pentyl propionate would not be be classified as a skin irritant according to the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.