Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
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

Constituent 1
Chemical structure
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.