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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N4-[3-(1H-imidazol-1-yl)propyl]-2-methylbenzene-1,4-diamine trihydrochloride
EC Number:
700-345-3
Cas Number:
515851-08-8
Molecular formula:
C13H21Cl3N4
IUPAC Name:
N4-[3-(1H-imidazol-1-yl)propyl]-2-methylbenzene-1,4-diamine trihydrochloride
Constituent 2
Reference substance name:
[TN]Kn 172[/TN][SPEC][/SPEC][AM]>99%[/AM]
IUPAC Name:
[TN]Kn 172[/TN][SPEC][/SPEC][AM]>99%[/AM]
Details on test material:
Kn 172
SAT 030768
Batch No.: Kn-Gi 8634/1

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Controls:
not required
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
1, 24, 48, 72 hours
Number of animals:
3

Results and discussion

Any other information on results incl. tables

No irritation was observed at treated site following a 4 hour exposure  period.
These results indicate that the test item, KN 172, has no irritant effect  on the skin of the rabbit following a 4 hour dermal exposure period.
European Directives concerning the classification, packaging and labelling  of dangerous substances and preparations (671548-EEC and subsequent  revisions) would indicate the following: Classification : Not required

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: not irritating
Executive summary:

The acute dermal imtation of KN 172 was investigated in the rabbit.

A 0.5 g aliquot of the substance was applied to the prepared dorsal skin of 3 animals for a

period of 4 hours. The resulting reaction to treatment was assessed 1, 24, 48 and 72 hours

after the end of the exposure period.

No imtation was observed at treated site following a 4 hour exposure period.

These results indicate that the test item, KN 172, has no irritant effect on the skin of the

rabbit following a 4 hour dermal exposure period.

European Directives conceming the classification, packaging and labelling of dangerous

substances and preparations (671548fEEC and subsequent revisions) would indicate the following:

Classification: Not required

Symbol: None indicated

R-phrase: None indicated