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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 406 (Skin Sensitisation) , 17 July 1992
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]
EC Number:
930-947-3
Cas Number:
146987-98-6
Molecular formula:
R-CO(NH)(CH2)(CH2)(CH2)N(Me2), whereas R=C8-18 (even numbered)
IUPAC Name:
Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shorn
Vehicle:
other: Sesame oil
Controls:
other: one flank of a same animal
Duration of treatment / exposure:
24 h - pilot experiment,
24 h - challenge dermal application
Observation period:
48 h
Number of animals:
10

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: grading in 5 of 10 animals
Time point:
other: 24 h
Score:
1 - 2
Max. score:
2
Reversibility:
no data
Remarks on result:
other: challenge procedure (1% of test item)
Irritation parameter:
edema score
Basis:
other: grading in 5 of 10 animals
Time point:
other: 24 h
Score:
1 - 2
Max. score:
2
Reversibility:
no data
Remarks on result:
other: challenge procedure (1% of test item)
Irritation parameter:
erythema score
Basis:
other: grading in 6 of 10 animals
Time point:
other: 48 h
Score:
1 - 2
Max. score:
2
Reversibility:
no data
Remarks on result:
other: challenge procedure (1% of test item)

Any other information on results incl. tables

Pilot Experiment:

The intradermal application of the 5 %, 3.5 % and 2 % (w/w) solutions of the test substance in vehicle showed a strong skin reaction and moderate skin reaction was observed with the 0.5 % and 0.1 % (w/w) concentration. Slight skin reaction was observed with the 0.05 % (w/w) concentration. Dermal application of the 100 %, 75 %, 50 % and 25 % (w/w) concentration of the test substance in vehicle without Duhring Chambers led to necrosis of the treated skin sites. The test substance preparation of 5 % (w/w) concentration showed a very slight reaction. Application of the 1 %, 0.5 % and 0.1 % (w/w) concentration in vehicle showed no reaction on the skin. Two animals of the pilot experiment have been sacrificed by an overdose of a narcotic substance shortly after observation of the strong skin reactions.

The intradermal and the epicutaneous induction resulted in slight skin reactions in a various number of animals indicating that the chosen test substance concentrations led to slight irritation.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
In the sensitization study with Amides, C6-C18, N-[3-(dimethylamino)propyl], (a.i.98.4%) the direct evidence of corrosive effect of the test substance applying to skin was ascertained.
The maximum compatible doses which led to slight irritation after intradermal and dermal application as well as the subirritative dose for the challenge were determined in a pilot experiment.
Moreover, the test article concentration for the challenge procedure was 1 %. In the challenge visible changes of the skin like slight and easily detectable erythema (= grading 1 and 2) and slight to easily recognizable swelling (= grading 1 and 2) were observed in five out of ten test group animals 24 h after patch removal; 48 h after the challenge these skin reactions were still observed and one additional animal showed slight erythema (= grading 1).
In conclusion, the test substance Amides, C6-C18, N-[3-(dimethylamino)propyl], (a.i.98.4%) is to be regarded as slightly corrosive grading 1-2.
Executive summary:

In the sensitization study with Amides, C6-C18, N-[3-(dimethylamino)propyl], (a.i.98.4%) the direct evidence of corrosive effect of the test substance applying to skin was ascertained.

The intradermal application of the 5 %, 3.5 % and 2 % (w/w) solutions of the test substance in vehicle showed a strong skin reaction and moderate skin reaction was observed with the 0.5 % and 0.1 % (w/w) concentration. Slight skin reaction was observed with the 0.05 % (w/w) concentration. Dermal application of the 100 %, 75 %, 50 % and 25 % (w/w) concentration of the test substance in vehicle without Duhring Chambers led to necrosis of the treated skin sites. The test substance preparation of 5 % (w/w) concentration showed a very slight reaction. Application of the 1 %, 0.5 % and 0.1 % (w/w) concentration in vehicle showed no reaction on the skin. Two animals of the pilot experiment have been sacrificed by an overdose of a narcotic substance shortly after observation of the strong skin reactions.

The maximum compatible doses which led to slight irritation after intradermal and dermal application as well as the subirritative dose for the challenge were determined in a pilot experiment. Moreover, the test article concentration for the challenge procedure was 1 %. In the challenge visible changes of the skin like slight and easily detectable erythema (= grading 1 and 2) and slight to easily recognizable swelling (= grading 1 and 2) were observed in five out of ten test group animals 24 h after patch removal; 48 h after the challenge these skin reactions were still observed and one additional animal showed slight erythema (= grading 1).

In conclusion, the test substance Amides, C6-C18, N-[3-(dimethylamino)propyl], (a.i.98.4%) is to be regarded as slightly corrosive grading 1-2.

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