Ethyl 3-ethoxypropionate

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP repeated dose skin irritation study

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:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Conducted according to standard operating procedures of the Eastman Kodak laboratory

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 3-ethoxypropionate

EC Number:

212-112-9

EC Name:

Ethyl 3-ethoxypropionate

Cas Number:

763-69-9

Molecular formula:

C7H14O3

IUPAC Name:

ethyl 3-ethoxypropanoate

Details on test material:

- Name of test material (as cited in study report): Ethyl 3-ethoxypropionate (EEP)
- Physical state: liquid
- Analytical purity: 99.8%
- Impurities (identity and concentrations): acetic acid, ethyl propionate and ethyl acrylate as the trace impurities
- Purity test date: no data
- Lot/batch No.: A total of three batches were received for inhalation tests. One batch, identified as SR1D:X-17695-233, was used exclusively for technical development and the LC 50 study (HS&HFL No. 83-0162).

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Details on exposure:

TEST SITE
- Area of exposure: Clipped backs of guinea pigs
- % coverage: no data
- Type of wrap if used: not used
- Time intervals for shavings or clipplings: no data
- All pigs depilated

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

No data

Duration of treatment / exposure:

9 over a 10 day period

Frequency of treatment:

Repeated applications (9 over a 10 day period).

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

Rub on clipped back skin 0.5 ml/day

Positive control:

Not applicable

Examinations

Observations and examinations performed and frequency:

BODY WEIGHT: Yes

Sacrifice and pathology:

Not applicable

Other examinations:

Not applicable

Statistics:

Not applicable

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Dermal irritation:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

not examined

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

CLINICAL SIGNS
Slight exacerbation observed.

Effects:
Erythema: 1st Dose: 0
Last Dose: 2

Four of five animals gained weight by study termination.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Erythema noted on Test Day 8.

Applicant's summary and conclusion

Conclusions:

Repeated applications (9 over a 10 day period) to the clipped backs of guinea pigs produced slight exacerbation of the irritative response. No evidence of percutaneous absorption was seen.