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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets scientific standards and acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Zur arbeitshygienisch-toxikologischen Beurteilung volkswirtschaftlich bedeutsamer chemischer Substanzen. 4. Kurzmitteilung: Technisches 2-Aethylhexylacetat (Octylacetat).
Author:
Schmidt P, Bachmann W
Year:
1969
Bibliographic source:
Z Gesamte Hyg. 15(12): 928-929

Materials and methods

Principles of method if other than guideline:
Study to assess the subacute dermal toxicity in rats.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl acetate
EC Number:
203-079-1
EC Name:
2-ethylhexyl acetate
Cas Number:
103-09-3
Molecular formula:
C10H20O2
IUPAC Name:
2-ethylhexyl acetate
Details on test material:
2-ethylhexyl acetate, technical purity

Test animals

Species:
rat
Strain:
other: albino
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: own breeding (randomized)
- Weight at study initiation: 163 (160-175) g
- Diet Standard diet K (VEG Altglienecke, Germany) ad libitum
- Water ad libitum

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on exposure:
TEST SITE
- Area of exposure: 3*4 cm, shaved skin
- Type of wrap if used: no wrap used; animals were immobilised during exposure


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
12 days
Frequency of treatment:
twice daily for 2 hours on 10 of 12 days
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0, ca. 1070 mg/kg bw/day
Basis:
nominal per unit body weight
Remarks:
Doses / Concentrations:
0, ca. 535 mg/kg bw/treatment
Basis:
nominal per unit body weight
Remarks:
Doses / Concentrations:
0, 0.1 ml/animal/ treatment
Basis:
nominal per unit area
No. of animals per sex per dose:
treatment: 12 females; control: 6 females
Control animals:
yes, concurrent no treatment
Details on study design:
Post-exposure period: 28 days

Examinations

Observations and examinations performed and frequency:
The condition of the skin was evaluated, the body weight of the animals was juged twice a week in the beginning, later on once a week.
Sacrifice and pathology:
At the end of the 28 days post exposure, the animals were sacrificed and the organs examined macroscopically.

Results and discussion

Results of examinations

Details on results:
No significant differences were observed between treated and control animals at any time.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Remarks:
systemic
Effect level:
>= 1 070 mg/kg bw/day (nominal)
Sex:
female
Basis for effect level:
other: no effects
Dose descriptor:
NOAEL
Remarks:
local
Effect level:
>= 1 070 mg/kg bw/day (nominal)
Sex:
female
Basis for effect level:
other: no effects
Dose descriptor:
NOAEL
Remarks:
local
Effect level:
>= 14.5 mg/cm² per day (nominal)
Sex:
female
Basis for effect level:
other: no effects

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

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