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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
slightly different grading system
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test material has surfactant properties and thus falls out of the applicability domain of the LLNA (see OECD TG 429)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Genamin CC 100 D (coco alkyl amines)

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc:DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 304 - 358 g
- Housing: Terluran cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours periodically

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
cotton seed oil
Concentration / amount:
Induction, first stage, intradermal: 0.1%
Induction, second stage, topical: 1%
Challange: 0.5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
cotton seed oil
Concentration / amount:
Induction, first stage, intradermal: 0.1%
Induction, second stage, topical: 1%
Challange: 0.5%
No. of animals per dose:
10 (test item), 5 (control)
Details on study design:
RANGE FINDING TESTS:
6 animals for intradermal treatment, two concentrations tested per animal
concentrations: 0.05, 0.1, 0.5, 2.5, 5, 10, 25, 50, and 100%
6 animals for topical treatment, two concentrations tested per animal
concentrations: 0.25 % (24 h); 0.5, 25, and 50% (24 and 48 h)


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 7 days (single intradermal), 48 h (topical)
- Test groups: 1
- Control group: 1
- Site: shoulder region
- Frequency of applications: 2
- Duration: 20 days
- Concentrations: 0.1% (intradermal), 1% (topical)


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 20
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: left flank
- Concentrations: 0.5%
- Evaluation (hr after challenge): 24, 48, 72 h
Challenge controls:
Yes
Positive control substance(s):
yes
Remarks:
mercaptobenzothiazole

Results and discussion

Positive control results:
Reliability check (not concurrent): The sensitisation rate after application of the positive control substance mercaptobenzothiazole (15 % in vaseline) was 90 %, confirming the reliability of the test system (BSL ID 072728)

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5 %
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 %
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: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 %
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: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading:

Any other information on results incl. tables

24 h after challange (removing the patch), erythema grade 1 was recorded for 2 out of 10 test animals. After 48 and 72 h, no further signs of irritation were observed. The maximum percentage of animals sensitized was 20%.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Considering the study results of this sensitization test it can be stated that the test item Coco alkyl amines can be regarded as non-sensitizer after
dermal exposure
Executive summary:

In a GLP-compliant OECD TG 406 skin sensitization study according to Magnusson-Kligmann (guinea pig - maximisation test, GPMT), 10 female guinea pigs + 5 control animals (strain Dunkin-Hartley) were treated with coco alkylamine ("Genamin CC 100 D", technical grade, purity 99.9%, liquid) using cotton seed oils as a vehicle. Based on the results of a pretest, a test substance concentration of 0.1% was used for intradermal induction (0.1 mL), followed by a 1% concentration at epidermal induction. Challenge was performed using a 0.5% substance concentration. For epidermal treatments, patches were loaded with 0.5 mL. In contrast to results of the pretest, no dermal irritation was observed after epidermal induction. After challenge treatment, 2/10 animals showed grade 1 erythema at the 24h reading (positive rate = 20%). One out of these positive animals showed scaling after 48 and 72h. Considering the reported data of this sensitization test it can be stated that the test item Coco alkyl amines caused slight reactions at the tested concentration in 2 out of 10 animals identified as sensitization. However, according to the EC criteria Coco alkyl amine does not classify as skin sensitizer as the sensitization rate was 20%.