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Diss Factsheets

Toxicological information

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:
June to July 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
- the second induction on Day 7 was performed by intradermal injection; two challenges were performed on Day 21 and Day 35 by topical application under occlusive conditions for 6 hours each
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The guinea pig maximisation test (GPMT) was an adequate in vivo skin sensitisation test at the time of performance in 1992.

Test material

Constituent 1
Reference substance name:
Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides
EC Number:
295-714-4
EC Name:
Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides
Cas Number:
92128-22-8
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Reaction products of tall-oil fatty acids and (3-aminopropyl)dimethylamine
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor: DHPW
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH (Borchen, Germany)
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: 320 - 404 g
- Housing: 5 animals per cage (Makrolon cages type IV) on low dust wood granulate bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1.5
- Humidity (%): 40 - 70
- Air changes (per hr): approx. 12 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
1st induction: 2.5 % 
2nd induction: 3 %
1st and 2nd challenge: 0.5 % and 1.0 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
1st induction: 2.5 % 
2nd induction: 3 %
1st and 2nd challenge: 0.5 % and 1.0 %
No. of animals per dose:
20 (test groups); 10 (control groups)
Details on study design:
INTRADERMAL INDUCTION: three pairs of intradermal injections were made at the clipped skin site of each animal. A volume of 0.1 ml was injected. Animals of the test group were treated at the following injection sites: 
cranial - emulsified Freund’s complete adjuvant 1:1 with physiol. NaCl
medial - 2.5 % test item in propylene glycol
caudal - 2.5 % test item in propylene glycol and emulsified Freund’s  complete aduvant 1:1
Animals of the control group were treated in the same manner excepted that the test item was replaced by the vehicle alone.

TOPICAL INDUCTION: treatment group: 0.5 ml of 3 % test item in propylene glycol; control group: 0.5 ml propylene glycol

CHALLENGE: 3 weeks after the first induction phase all animals were prepared for challenge by clipping the flanks and backs free of hair. Patches of gauze coated with 5 ml aliquots of the test item at 1 and  0.5 % concentrations were placed alternating cranial or caudal of each animal. The treated sites were covered with a strip of aluminium foil and elastic adhesive bandage. After a contact period of 24 hours patches were removed. The treated sites were examined approximately 48 and 72 hours after patch  removal.
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 % test substance formulation
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 % test substance formulation. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1 % test substance formulation
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1 % test substance formulation. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 % test substance formulation
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 % test substance formulation. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
1 % test substance formulation
No. with + reactions:
3
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1 % test substance formulation. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 % test substance formulation
No. with + reactions:
11
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 % test substance formulation. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.5 % test substance formulation
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 % test substance formulation. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 % test substance formulation
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 % test substance formulation. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.5 % test substance formulation
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.5 % test substance formulation. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

None of the animals in the test groups reacted to the control patch moistened with the vehicle.

After challenge treatment skin redness in 95 % of the animals (grade 1 to 3) after 1 % test item and in 55 % of the animals (grade 1 to 2) after 0.5 % test item were observed. Skin reactions in the control groups were recorded in 40 % and 10 % of the animals after 48 hours. All positive reacting animals showed no formation of edema. 72 hours after the challenge skin reactions still persisted in most of the affected animals.

The treatment with the test substance was tolerated without clinical symptoms by all animals.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Executive summary:

In a guinea pig maximization test (GPMT) according to OECD TG 406 the test substance revealed a skin sensitizing potential at challenge concentrations of 0.5 and 1 %. 48 hours after the challenge skin reactions were observed in 95 % of the animals (grade 1 to 3) after 1 % test item and in 55 % of the animals (grade 1 to 2) after 0.5 % test item. 72 hours after the challenge skin reactions still persisted in most of the affected animals.