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Skin sensitisation

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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

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