trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-06-19 to 1986-08-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

12 May 1981

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol

EC Number:

419-050-3

EC Name:

trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol

Cas Number:

79944-37-9

Molecular formula:

C7H15NO3

IUPAC Name:

6-amino-2,2-dimethyl-1,3-dioxepan-5-ol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Schriever
- Weight at study initiation: 2.5-2.9 kg (males and females)
- Housing: individually under conventional conditions in metal cages
- Diet (e.g. ad libitum): ad libitum; pellet. Altromin K
- Water (e.g. ad libitum): ad libitum; demineralized water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 40-56
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: moistened with aqua bidist.

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

4 days

Number of animals:

2/sex/group

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Both sites (treated and untreated) were covered with a piece of gauze (semiocclusive) fixed on the skin with Leukoflex(R).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure the gauze was removed and the treated and untreated skin areas were wiped off carefully with luke warm tap water and cotton wool.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
30-60 min after exposure and thereafter every 24 h until day 4

SCORING SYSTEM: according to Draize et al.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.19

Max. score:

4

Reversibility:

fully reversible within: 1d

Irritant / corrosive response data:

After a single dermal application of ZK 38.199 on the intact skin of the rabbit transient slight reddening was observed in two animals on application day. The irritation index according to Draize was 0.19, indicating slight irritation. The irritation was reversible within the first day.

Any other information on results incl. tables

Local findings

Findings	Right side (treated with test item)		Left side untreated
	A	(B)	Without findings
Very slight reddening of the area of administration	1/1	(1-1)
Patchy slight reddening	1/1	(1-1)
Without findings	14/4	(1-4)
A = summation of positive findings/number of animals concerned (B) = (first — last day of occurrence of a finding) [within the first hour]

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The above mentioned transient finding after a single application of Aminodioxepan on the intact skin of the rabbit was classified as a very slight negligible incompatibility reaction. Thus, the substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Executive summary:

In a primary dermal irritation study similar to OECD test guideline 401, young adult Wistar rats (2/sex) were dermally exposed to 2000 mg/kg bw of Aminodioxepan (100 % a.i.) moistened with water for 4 hours. Animals then were observed for 4 days. Irritation was scored by the method of Draize et al..

The only local finding after treatment with the test item was slight transient reddening of the skin in 2/4 animals on day 1 of the test. The irritation index according to Draize was 0.19, indicating slight local irritation.

Thus, in this study, Aminodioxepan is not a dermal irritant.