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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan. 1993 to May 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

3 animals/ group instead of 5

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1989

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Schering
- Weight at study initiation: 90-109 g males; 89-105 g females
- Fasting period before study: 19 h
- Housing: individually under conventional conditions
- Diet (e.g. ad libitum): ad libitum; pell. Altromin® R
- Water (e.g. ad libitum): ad libitum, demineralized acidified water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 52-63


IN-LIFE DATES: From: 1993-01-05 To: 1993-01-18

Administration / exposure

Type of coverage:

not specified

Vehicle:

physiological saline

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

yes, concurrent no treatment

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing on days 1, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 of Aminodioxepan in male and female rats after a single dermal application is > 2000 mg/kg body weight.

Executive summary:

In an acute dermal toxicity study according to Roll, R. et al., Bundesgesundheitsblalt 8/89, 336-340, groups of young adult Wistar rats (3/sex) were dermally exposed to Aminodioxepan (100% a.i) in 0.9% NaCl for 24 hours at a dose of 2000 mg/kg bw.  Animals then were observed for 14 days.

Dermal LD50 Combined => 2000 mg/kg bw

No mortality occurred in this limit test.

Aminodioxepan is of LOW Toxicity based on the LD50 in male and female Wistar rats.

There were no treatment related clinical signs, necropsy findings or changes in body weight.