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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study report obtained through inquiry process. SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: 2,2,6,6-tetramethylpiperidin-4-yl-hexadecanoate; 2,2,6,6-tetramethylpiperidin-4-yl-octadecanoate
EC Number:
415-430-8
EC Name:
A mixture of: 2,2,6,6-tetramethylpiperidin-4-yl-hexadecanoate; 2,2,6,6-tetramethylpiperidin-4-yl-octadecanoate
Cas Number:
86403-32-9
Molecular formula:
C25H49NO2 and C27H53NO2
IUPAC Name:
Reaction mass of 2,2,6,6-tetramethylpiperidin-4-yl hexadecanoate and 2,2,6,6-tetramethylpiperidin-4-yl octadecanoate

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
Substance was applied directly.
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
11 days
Number of animals:
3
Details on study design:
Additional data is forthcoming.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 11 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 hour through 11 days
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 11 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 hour through 11 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritant / corrosive response data:
Erythema and oedema were observed in all animals up to 7 days after patch removal.
Inconsistent reactions among animals.
Related to all animals: Max. duration: 10 d; Max. value at end of observation period: 0.
Reversibility of any observed effect: Changes fully reversible within 11 days
Other effects:
No further toxicological effects.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A guideline study (OECD No. 404) was undertaken in 3 albino rabbits where the 0.5 g of test material was placed under a semiocclusive patch on shaved intact skin for 4 hours. Mild erythema and oedema (a maximum of 2 on a Draize scale of 4) were observed in all animals up to 7 days after patch removal but were fully reversible within 10 to 11 days after patch removal. The substance was determined to be slightly to moderately irritating the skin of rabbits, but was noted to be "not classified" according to CLP Regulation (EC) No. 1272/2008.