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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
between 12-12-1994 and 15-12-1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The information is used for read across to Zenolide.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-dioxacycloheptadecane-5,17-dione
EC Number:
203-347-8
EC Name:
1,4-dioxacycloheptadecane-5,17-dione
Cas Number:
105-95-3
Molecular formula:
C15H26O4
IUPAC Name:
1,4-dioxacycloheptadecane-5,17-dione
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
other: SPF albino rabbits
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Møllegaard Breeding and Research Centre AJS, Ejby, DK-4623 Lille Skensved
- Weight at study initiation: 2.0 - 2.1 kg
- Housing: Single in 62 x 52 cm PPO cages with perforated floor.
- Diet: A pelleted complete rabbit diet “Altromin 2123” from Chr. Petersen, DK-4100 Ringsted, ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Ethanol 96% and diethyl phthalate (DEP)
Controls:
no
Amount / concentration applied:
100, 20, 10, 5, 1% (w/w)
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 28, 72 hours after termination of exposure
Number of animals:
4
Details on study design:
TEST SITE
The day before the experiment was started the rabbits were weighed and an area of 10 x 10 cm on the back was clipped as closely as possible with an electric clipper. On the experimental day the rabbits were physically restrained on a test table, and the clipped area was divided into 6 test sites: 2 anterior located test sites, 2 centrally located test sites and 2 posterior located test sites. To each of 6 gauze patches (2.5 x 2.5 cm) 0.5 ml of 1 of the test concentrations or the vehicle was applied and the patches were placed on the appropriate test site at the back of each rabbit. The gauze patches were secured with a semi-occlusive dressing by means of a 1 cm wide adhesive tape and fixed with Scanpor tape, 4.5 cm width, loosely wound round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: cleaned with soap and lukewarm water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after termination of exposure

SCORING SYSTEM: According to OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight dose related (100%, 20% and 10% test concentrations) skin erythema was observed 1 hour after termination of exposure. Thereafter no abnormalities were observed.
Other effects:
no

Applicant's summary and conclusion

Interpretation of results:
other: Not a skin irritant
Remarks:
according to CLP (EC 1272/2008 and its updates
Conclusions:
In an OECD guideline 404 study conducted in compliance with GLP, the test substance is considered to be not irritating to the skin.
Executive summary:

In a skin irritation study performed in accordance with GLP and OECD guideline 404 four albino rabbits were exposed semi-oclusive to 5 different concentrations (100, 20, 10, 5, and 1% w/w) of the test substance at 6 skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure. Slight dose related (100%, 20% and 10% test concentrations) skin erythema was observed 1 hour after termination of exposure. Thereafter, no abnormalities were observed. The test substance was found not to be skin irritant when applied topically to the rabbit.