1,4,7,10-Tetraazacyclododecane, 1,4,7,10-tetrakis(phenylmethyl)-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

from Sept. to Oct. 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study conducted similar to guideline

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Acute-toxic-class method

Principles of method if other than guideline:

This study is a combined study on acute dermal toxicity and on local tolerance with 3 animals per sex

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

449-410-5

EC Name:

-

Cas Number:

18084-64-5

Molecular formula:

C36H44N4

IUPAC Name:

1,4,7,10-Tetrabenzyl-1,4,7,10-tetraazacyclododecane

Test animals

Species:

rat

Strain:

other: HAN: WIST (SPF)

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: pasted with paraffin oil (184-196 mg substance with 0.3 ml vehicle)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

No animal died in the course of the study. A single dermal application of 2000 mg/kg was tolerated without systemic toxicity. The body weight gain was within the normal range for rats of this age and strain. No compound- related clinical findings could be detected at the end of the study on day 14. Autopsy revealed no compound-related systemic findings. Skin reddening and scab formation was observed.

Applicant's summary and conclusion

Executive summary:

A single dermal administration of the test substance to male and female rats at the limit-dose of 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. Local effects appeared as skin reddening and scab formation. The dermal LD50 of the test substance is therefore determined with > 2000 mg/kg body weight.