Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with OECD guideline 406 and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A guideline and GLP-compliant guinea pig maximisation test was available from a time before the LLNA-OECD-TG was adopted. The information is sufficient to evaluate the sensitising potential of the test substance. Hence, a LLNA was not conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[3-(dimethylamino)propyl]oleamide
EC Number:
203-661-5
EC Name:
N-[3-(dimethylamino)propyl]oleamide
Cas Number:
109-28-4
Molecular formula:
C23H46N2O
IUPAC Name:
(9Z)-N-[3-(dimethylamino)propyl]octadec-9-enamide
Test material form:
other: liquid
Details on test material:
Color: yellow
Batch: R401/57
Purity: 89% (acid number)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
Supplier: Charles River (F-69592 L'Arbresle)
Weights at beginning of study: 264-306 g
Age at beginning of study: 4 weeks

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Induction: 0.3906% (intradermic injection), 100% (topical application)
Challenge: 1.5625% and 0.7813%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Induction: 0.3906% (intradermic injection), 100% (topical application)
Challenge: 1.5625% and 0.7813%
No. of animals per dose:
Negative control group: 5 animals
Treated group: 11 animals
Details on study design:
PRELIMINARY STUDIES:
3 preliminary studies were conducted to determine the maximal non necrotizing concentration (MNNC) by intradermal injection, the pre-maximal non irritant concentration (Pre-MNIC) by topical application, and the maximal non irritant concentration (MNIC) by topical application, respectively.
To determine the MNNC, two animals received on both sides of the spine, a volume of 0.1 ml of the test item at 6 concentrations: 100%, 50%, 25%, 12.5%, 6.25% and 3.125% in olive oil. A macroscopic evaluation of the cutaneous reactions was conducted 24 hours later and 48 hours later
if necessary. Due to the necrosis registered at these 6 concentrations, the two animals received on both sides of the spine, a volume of 0.1 ml of the test item, at 4 concentrations: 1.5625%, 0.7813%, 0.3906% and 0.1953% in olive oil. A macroscopic evaluation of the cutaneous reactions was conducted 24 hours later and 48 hours later if necessary.
To determine the Pre-MNIC, the test item was applied on the dorso-lumbar zone of two guinea pigs shorn beforehand, with occlusive dressing for 24 hours, at 4 different concentrations: 100%, 50%, 25% and 12.5% in liquid paraffin. A macroscopic evaluation of the cutaneous reactions was conducted 24 hours after removal of the dressing.
Finally, for determining the MNIC, three guinea pigs were treated according to the negative control group for the induction phase (i.e. olive oil and liquid paraffin). During the challenge phase, the animals were treated with the test item placed onto the selected treatment sites and covered with an occlusive dressing for a period of 24 hours at 4 different concentrations: 6.25%, 3.125%, 1.56% and 0.78% in liquid paraffin. A macroscopic evaluation of the cutaneous reactions was conducted 24 hours after removal of the occlusive dressing.

MAIN STUDY:
A. INDUCTION PHASE:
Number of exposures: 2 (intradermal on day 0 and topical on day 6)
Negative control group: received 3 pairs of intradermal injection (ID) of 0.1 ml (one injection of each pair placed on either side of the spine): 2 ID containing Freund’s Complete Adjuvant diluted at 50 % in isotonic sodium chloride, 2 ID containing olive oil, and 2 ID containing a mixture with equal volumes v/v of Freund’s Complete Adjuvant at 50% and isotonic sodium chloride
Treated group: received 3 pairs of intradermal injection (ID) of 0.1 ml (one injection of each pair placed on either side of the spine): 2 ID: containing Freund’s Complete Adjuvant diluted by 50 % in isotonic sodium chloride, 2 ID containing test item at 0.3906%, and 2 ID a test mixture in equal volumes v/v Freund’s Complete Adjuvant at 50% and the test item at 0.7813%.
On day 6 of the study, the scapular zone of all animals in each group was shorn, followed by topical application under occlusive dressing for 48 hours on the injection sites: 0.5 ml of liquid paraffin (negative control) and 0.5 ml of the test item at 100% (treated group), respectively.

B. CHALLENGE PHASE
On day 20 of the study, the animals of both groups were treated as follows: 1 sample cup containing the test item at 1.56% (MNIC) and at 0.78% (1/2 MNIC) was applied to the previously shorn dorso-lumbar zone on either side of the spine for 24 hours under occlusive dressing.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1.56%
No. with + reactions:
11
Total no. in group:
11
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.56%. No with. + reactions: 11.0. Total no. in groups: 11.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.781%
No. with + reactions:
11
Total no. in group:
11
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.781%. No with. + reactions: 11.0. Total no. in groups: 11.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1.56%
No. with + reactions:
11
Total no. in group:
11
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.56%. No with. + reactions: 11.0. Total no. in groups: 11.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.781%
No. with + reactions:
11
Total no. in group:
11
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.781%. No with. + reactions: 11.0. Total no. in groups: 11.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1.56%
No. with + reactions:
3
Total no. in group:
11
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1.56%. No with. + reactions: 3.0. Total no. in groups: 11.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.781%
No. with + reactions:
1
Total no. in group:
11
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.781%. No with. + reactions: 1.0. Total no. in groups: 11.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1.56%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1.56%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.781%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.781%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1.56%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.56%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.781%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.781%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
1.56%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1.56%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.781%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.781%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It can be concluded that under the experimental conditions chosen, the test item Trennmittel ZM 121 caused skin sensitisation in the guinea pig maximization test. Based on the results of the study, the test substance needs to be classified as a category 1A skin sensitiser (H317 - May cause allergic skin reactions) according to Regulation (EC) No 1272/2008 (CLP).
Executive summary:

The test substance Trennmittel ZM 121 was tested for a possible allergenic activity after intradermic injection and topical administration in guinea pigs. The study was conducted according to OECD guideline 406. After induction (intradermic injection at 0.3906% and topical application at 100%) of 11 animals and a 10-day rest phase, the animals were challenged by a single topical application of the test item diluted at 1.5625% and 0.7813% in liquid paraffin under occlusive dressing for 24 hours. After the challenge phase, a moderate erythema associated with a slight to moderate oedema was detected at the skin area treated with 1.5625% in all animals. A significant macroscopical cutaneous reaction at this application site was still registered in 100% and 27% of the animals 48 and 72 hours after the challenge phase, respectively. At the sites treated with 0.7813%, a slight to moderate erythema, in part associated with a slight to moderate oedema, was detected in all animals 24 hours after the challenge phase. A significant macroscopical cutaneous reaction was still registered in 100% (11/11) and 9% (1/11) of the animals at this application site 48 and 72 hours after the challenge phase, respectively. No cutaneous intolerance reaction was recorded in animals from the negative control group.

It can be concluded that under the experimental conditions chosen, the test item Trennmittel ZM 121 caused skin sensitisation in the guinea pig maximization test. Based on the results of the study, the test substance needs to be classified as a category 1A skin sensitiser (H317 - May cause allergic skin reactions) according to Regulation (EC) No 1272/2008 (CLP).