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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test.
Title:
Unnamed
Year:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.4.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-450-9
EC Name:
-
Cas Number:
294-90-6
Molecular formula:
C8H20N4
IUPAC Name:
1,4,7,10-tetraazacyclododecane
Test material form:
not specified
Details on test material:
- Substance name: 1,4,7,10-tetraazacyclododecane

In vitro test system

Control samples:
yes, concurrent vehicle

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
other: Distilled Water
Amount / concentration applied:
500mg
Duration of treatment / exposure:
4h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
( mean score 3)
Time point:
24/48/72 h
Score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Max. duration: 21; Max. value at end of observation period: 4 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Max duration: 21d; Max. value at end of observation period: 2 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 21 days.
Other effects:
One animal died on day 19, but there was no indication of substance relationship.

Applicant's summary and conclusion

Interpretation of results:
other: Corrosive
Remarks:
Migrated information criteria used for interpretation of results: EU
Conclusions:
Test substance, after 72h, was classified as corrosive with not fully reversibility of observed effects.
Executive summary:

A skin irritation/corrosion test was performed according to OECD guideline 404, and 92/69/EWG, B.4 under GLP conditions.

500mg of test substance were administered to three New Zealand White rabbits in semiocclusive conditions using distilled water as a vehicle. Test substance effects were not fully reversible within 21 days.

Regarding the available data, test substance was classified as corrosive.