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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1987
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2019
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
Freund's complete adjuvant test
Justification for non-LLNA method:
study done in 1987 according to OECD method 406

Test material

Constituent 1
Reference substance name:
Amides, coco, N-[3-(dimethylamino)propyl]
EC Number:
268-771-8
EC Name:
Amides, coco, N-[3-(dimethylamino)propyl]
Cas Number:
68140-01-2
IUPAC Name:
Amines, C12-18, alkyldimethyl
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
6 females and 4 males

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: 5% test material in acetone/PEG400
Concentration / amount:
0.2 - 0.3 mL
Day(s)/duration:
7 days
Adequacy of induction:
not specified
Challenge
No.:
#10
Route:
epicutaneous, occlusive
Vehicle:
other: 0.5% test material in acetone/PEG400
Concentration / amount:
0.2 - 0.3 mL
Day(s)/duration:
14 days
Adequacy of challenge:
not specified
Details on study design:
GPMT study in 10 Albino Dunkin/Hartley guinea pigs (6 females and 4 males).
- A single occlusive 48h induction patch (2 x 4 cm2) of 0.2 - 0.3 mL,
- a week following intradermal injections : Control group was 4 males that received intradermal injection and induction patches using only the vehicle mixture.
- After two week rest : single occlusive 24h challenge patch (8mm diameter in a Finn chamber);
- two more challenges were made one and two weeks after the first challenge.
Reactions were scored on a scale of 0 (no reaction) to 3 (severe erythema and edema).
Challenge controls:
4 males that received intradermal injection and induction patches using only the vehicle mixture
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
none
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
not specified
Remarks on result:
not measured/tested
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
5% acetone/PEG400
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
not specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
5% acetone/PEG400
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
not specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5% acetone/PEG400 for the induction patch
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
negative control
Dose level:
5% acetone/PEG400 for the induction patch
No. with + reactions:
1
Total no. in group:
4
Clinical observations:
not specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
5% acetone/PEG400 for the induction patch
No. with + reactions:
0
Total no. in group:
4
Clinical observations:
not specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5% acetone/PEG400 for the induction patch
No. with + reactions:
1
Total no. in group:
4
Clinical observations:
not really specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5% test material in acetone/PEG400 for challenge patch
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
8 animals out of 10 had a reaction score of 2
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5% test material in acetone/PEG400 for challenge patch
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
All 10 animals had a score >= 1 after patch removal
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5% test material in acetone/PEG400 for challenge patch
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
5 animals out of 10 had a reaction score of 2
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5% test material in acetone/PEG400 for challenge patch
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
7 animals had a reaction score >= 0.5 after patch removal
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5% test material in acetone/PEG400 for challenge patch
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
6 animals had a reaction score >= 0.5 and 3 out of 10 had reaction score of 2
Remarks on result:
not determinable
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5% test material in acetone/PEG400 for challenge patch
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
7 animals had a reaction score >= 0.5 at 24h after the removal of the patch
Remarks on result:
not determinable

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Cocamidopropyl Dimethylamine is a skin sensitizer