Pentyl propionate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 to OECD TG 402 and the report contains suffficient 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 402 (Acute Dermal Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

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

Sex:

male/female

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

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

New Zealand White rabbits were subjected to 24 hours of contact with the test material retained under impervious sheeting on the clipped, intact skin of the trunk. For larger doses, gauze was wrapped around the trunk over the sample to prevent leakage. Vetrap bandaging tape was wrapped over the impervious sheeting and the animal returned to its cage for the contact period. After the contact period, excess fluid was removed to prevent accidental ingestion.

Duration of exposure:

assumed to be 1 hour

Doses:

16 ml/kg

No. of animals per sex per dose:

5 male + 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for skin reactions and body weights - 1 hour, 7 days and 14 days
- Necropsy of survivors performed: yes

Statistics:

LD50 and the estimated LD50 slopes are estimated by the moving average method

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 13920 mg/kg (based on density of 0.87)

Mortality:

None

Clinical signs:

other: None noted in males while in females one animal appeared emaciated with distended abdomen and diarrhoea.

Gross pathology:

No gross pathological changes attributable to exposure were noted

Other findings:

not applicable

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, the dermal LD50 of the UCAR n-pentyl propionate to New Zealand White rabbits was greater than 16 ml/kg (equivalent to 13920 mg/kg) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.

Executive summary:

In this dermal study, a group of 5 male and 5 female New Zealand rabbits (adults, weighing between 2.0 -3.0 kg) were exposed to 16 ml/kg of UCAR n-pentyl propionate under occlusive conditions and observed for 14 days for mortality and signs of toxicity. There were no mortalities noted and clinical signs of toxicity were limited to 1 female animal which appeared to be emaciated with distended abdomen and diarrhoea. Under the conditions of the study, the dermal LD50 of the UCAR n-pentyl propionate to New Zealand White rabbits was greater than 16 ml/kg (equivalent to 13920 mg/kg) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.