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REACH

1,4-dioxacycloheptadecane-5,17-dione

EC number: 203-347-8 | CAS number: 105-95-3

Life Cycle description
Uses advised against

Toxicological information

Skin irritation / corrosion

Administrative data

Endpoint:: skin irritation: in vivo
Type of information:: experimental study
Adequacy of study:: key study
Study period:: From 1994-12-12 to 1994-12-15
Reliability:: 1 (reliable without restriction)
Rationale for reliability incl. deficiencies:: other: Study performed according to OECD test guideline No. 404 and in compliance with GLP.

Cross-referenceopen all close all

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:: 1994
Report date:: 1994

Materials and methods

Test guidelineopen all close all

Test guideline 1

Qualifier:: according to guideline
Guideline:: OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:: no

Test guideline 2

Qualifier:: according to guideline
Guideline:: EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:: no

Principles of method if other than guideline:: The study was extended to investigate 5 different concentrations of the test article and a vehicle control on each animal
GLP compliance:: yes (incl. QA statement)
Remarks:: OECD GLP (inspection date: 6-7 April, 1994)

Test material

Test material information

Test material form:: other: liquid
Details on test material:: - Name of test material (as cited in study report): HR 94/130966
- Physical state: Viscous clear liquid
- Storage condition of test material: at room temperature in the dark

Test animals

Species:: rabbit
Strain:: other: SPF albino
Details on test animals or test system and environmental conditions:: TEST ANIMALS:
- Source: stock Mol:Russian from Mollegaard Breeding and Research Centre A/S, Ebjy, DK-4623 Lille Skensved
- Age at study initiation: no data
- Weight at study initiation: 2.0 - 2.1 kg bw
- Housing: individually, in 62 x 52 cm PPO cages with perforated floor
- Diet (e.g. ad libitum): pelleted complete diet ad libitum ("Altromin 2123" from Chr. Petersen, DK-4100 Ringsted)
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 55 +/- 5 %
- Air changes (per hr): 10 per hr
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:: semiocclusive
Preparation of test site:: shaved
Vehicle:: other: ethanol:diethyl phtalate (1:1 w/w)
Controls:: other: a site of each animal served as vehicle control
Amount / concentration applied:: TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution): 100, 20, 10, 5, 1 and 0 % on each animal
Duration of treatment / exposure:: 4 hours
Observation period:: 1, 24, 48 and 72 h after termination of the exposure
Number of animals:: 4 females
Details on study design:: TEST SITE
- Area of exposure: an area of 10 x 10 cm on the back was clipped and divided into 6 test sites: 2 anterior, 2 centrally and 2 posterior. Each site had an area of 2.5 x 2.5 cm
- Type of wrap if used: 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 (if done): soap and lukewarm water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scale according to the OECD 404

Results and discussion

In vivo

Results 1

Irritation parameter:: erythema score
Basis:: mean
Remarks:: 4 animals
Time point:: other: mean 24-48-72h
Score:: 0
Max. score:: 4
Remarks on result:: other: for each test concentration

Results 2

Irritation parameter:: edema score
Basis:: mean
Remarks:: 4 animals
Time point:: other: mean 24-48-72h
Score:: 0
Max. score:: 4
Remarks on result:: other: for each test concentration

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:: none

Any other information on results incl. tables

Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of animals from the test – 100 %

Score at time point / Reversibility	Erythema Max. score 4	Oedema Max. score 4
1 h	1 / 1 / 1 / 1	0 / 0 / 0 / 0
24 h	0 / 0 / 0 / 0	0 / 0 / 0 / 0
48 h	0 / 0 / 0 / 0	0 / 0 / 0 / 0
72 h	0 / 0 / 0 / 0	0 / 0 / 0 / 0
Average 24h, 48h, 72h	0.0 / 0.0 / 0.0	0.0 / 0.0 / 0.0
Reversibility*)	-	-
Average time (day) for reversion**	-	-