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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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