Butyl 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 equivalent or similar 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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butyl propionate

EC Number:

209-669-5

EC Name:

Butyl propionate

Cas Number:

590-01-2

Molecular formula:

C7H14O2

IUPAC Name:

butyl propanoate

Details on test material:

- Name of test material (as cited in study report): UCAR n-butyl propionate
- Physical state: clear clolourless low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: 51-18
- Stability under test conditions: yes
- 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: assumed to be in-house
- Age at study initiation: assumed to be adults
- Weight at study initiation: no information available
- Fasting period before study: fasted overnight before dosing
- Housing: assumed to be individually housed
- Diet (e.g. ad libitum): ad libitum except during exposure
- Water (e.g. ad libitum): ad libitum except during exposure

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

Duration of treatment / exposure:

4-hour

Observation period:

7-14 days

Number of animals:

6 rabbits

Details on study design:

0.5 ml of UCAR n-butyl propionate was applied to the clipped intact skin under a gauze patch and loosely covered with impervious sheeting. Excess sample was removed after contact and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days, 7 days and 10 and 14 days after application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: no irritation noted

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: no irritation noted

Irritant / corrosive response data:

There were no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate

Other effects:

One rabbit was found dead on day 7 with no evidence of this being related to the treatment.

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, no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for skin irritation.

Executive summary:

In this study, 0.5 ml of UCAR n-butyl propionate was topically applied to the clipped intact skin (trunk) of 3 male and 3 female New Zealand White rabbits, under a gauze patch and loosely covered with impervious sheeting. Excess sample was removed after contact and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days, 7 days and 10 and 14 days after application. There were no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate. An incidental mortality unrelated to the exposure of one male rabbit on day 7 was noted.

Under the conditions of the study, no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for skin irritation.