1H-Azepine, 1-[2-[4-(chloromethyl)phenoxy]ethyl]hexahydro-, hydrochloride (1:1)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-(4-(chloromethyl)phenoxy)ethyl)azepane hydrochloride

Cas Number:

223251-25-0

Molecular formula:

C15H23Cl2NO

IUPAC Name:

1-(2-(4-(chloromethyl)phenoxy)ethyl)azepane hydrochloride

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

The test item was diluted in bi-distilled water at a concentration of 0.5 g/ml and administered at a volume of 4 ml/kg.

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

5

Details on study design:

The animals were examined for clinical signs dailyfour times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1. During test days 2-15 was recorded two times a day.
Body weight were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

Moderate necrosis on the back and gaps in the skin were observed in male 1 from test day 2 until the end of the study. Slight necrosis and scales were evident in the other males between test day 2 and 15. Yellow skin on the application place, slight scales and slight or moderate crust on the back were evident in the females between test day 2 and the end of the study. Slight necrosis was noted on the back in one female between study days 2 and 7.

Body weight:

Body weight within the common range.

Gross pathology:

no macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of the substance after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg b.w.