Registration Dossier

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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.