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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
from Sept. to Okt. 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions: A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion. The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint.
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:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
- exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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)

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: pasted with paraffin oil
Controls:
other: the untreated skin served as control
Amount / concentration applied:
186-196 mg/male animal or 184-192 mg/female animal
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3 males and 3 females

Results and discussion

Any other information on results incl. tables

Skin reddening and scab formation at the application sites were observed (score 1.7). No swelling was seen.

Applicant's summary and conclusion

Executive summary:

A combined study on acute dermal toxicity and on local tolerance was conducted . The study design and reporting deviates from the current OECD TG 404, however, the study was considered suitable for assessment of skin irritation/corrosion.A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg under occlusive conditions was tolerated with local irritations, seen as skin reddening and scab formation (score 1.7).