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Description of key information

Read across is made with hydrogenated tallow alkylamines inside the primary alkylamines category. Data for hydrogenated tallow alkylamines with regard to skin sensitization are available. Additionally, also data from the closely related primary alkylamines C12-18-(even numberd)-alkylamines are existing. In a skin sensitization study according to OECD TG 406 (Magnusson and Kligman guinea pig-maximization test), 10 female guinea pigs and 5 control animals were treated with hydrogenated tallow alkylamines as aqueous dilutions. A test concentration of 1% was used for intradermal induction, followed by a 5% concentration at epidermal induction. Challenge was performed using a 0.5% substance concentration. From the results of this study, no indication of significant skin sensitizing properties exist. Likewise negative results were also obtained with C12-18-(even numbered)-alkylamines.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 Apr - 27 Apr 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to accepted standards at time of performance. Basic data given and well documented. No GLP study.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
- limited documentation
GLP compliance:
no
Remarks:
study was conducted before GLP was implemented
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)
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Porcellus Animals Ltd.
- Weight at study initiation: 300-400 g
- Housing: 5 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): water; ad libitum

Route:
other: intradermal and epicutaneous (occlusive)
Vehicle:
water
Concentration / amount:
The test substance was diluted to 1% concentration (w/w) in water for intradermal induction, to 5% concentration (w/w) in water for epicutaneous
induction and to 2% concentration (w/w) in water for epicutaneous challenge.
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
The test substance was diluted to 1% concentration (w/w) in water for intradermal induction, to 5% concentration (w/w) in water for epicutaneous
induction and to 2% concentration (w/w) in water for epicutaneous challenge.
No. of animals per dose:
10 (test group)
5 (control group)
Details on study design:
RANGE FINDING TESTS: Preliminary tests indicated that the test article was moderately irritant at 10% (w/w) and 5% (w/w) and should be non-irritant at a concentration of 2% (w/w) in water on adjuvant pre-treated animals when applied to the shaved flank under occlusion.

MAIN STUDY
A. INDUCTION EXPOSURE
intradermal phase:
The hair was removed from an area 4x6 cm across the scapular region of 10 animals. Two rows of 3 intradermal injections were given on each side of the mid-line as follows:
0.1 mL Freund´s adjuvant alone
0.1 mL test agent alone
0.5 mL test agent emulsified with 0.05 mL Freund´s adjuvant

epicutaneous phase:
6 days after the injection phase, the injection site was shaved again and treated with 10% sodium lauryl sulphate for 24 h (unbandaged) to provoke a inflammatory reaction.
24 h later, a 2x2 cm patch of Whatman No. 3 MM filter paper saturated with the test article (5% w/w in water) was applied to the pre-treated area for
48 h and the patch covered by an overlapping patch of impermeable plastic adhesive tape (Blenderm). The whole area was then firmly bound by Sleek occlusive tape.

B. CHALLENGE EXPOSURE
Two weeks after the epicutaneous induction a 5x5 cm area on the right flank of each test animal was shaved. A test concentration of 2% (w/w) in water was applied on a 2x2 cm patch of Whatman No. 3 MM filter paper to the prepared test site of the animals. The patch was covered by an overlapping patch of impermeable plastic adhesive tape (Blenderm). The whole area was then firmly bound by Sleek occlusive tape. The patch was removed 24 h later.
Challenge controls:
5 animals were injected with Freund´s adjuvant only (2 injections of 0.1 mL) at the induction phase. At the challenge phase, the test article was applied at a concentration of 2% (w/w, in water) to the shaved right flanks of 5 animals which had pre-treatment with adjuvant only at the induction phase.
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical findings.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
7
Clinical observations:
no clinical findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 7.0. Clinical observations: no clinical findings.

The test article was tested at the challenge phase, on 5 animals which were adjuvant pre-treated only. None of these control animals reacted positively to the epicutaneous application at the challenge phase. Therefore a test concentration of 2% (w/w) in water would be non-irritant.

The test article did not elicit positive responses in the test group after challenge of the 10 animals by epicutaneous application at the challenge phase. From these results it is concluded that this product is a non-sensitiser in guinea pigs.

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The sensitization potential of Stearyl Amine ("Amine HBG") was investigated by the Magnusson-Kligman maximization method. Based on the study results there is no evidence that this material is a sensitizer in guinea pigs.
Executive summary:

In a non-GLP-compliant skinstudy according to OECD TG 406 (Magnusson-Kligmann guinea pig - maximisation test), 10 female guinea pigs (strain Dunkin-Hartley + 5 control animals) were treated with hydrogenated tallow alkylamines ("Amin HBG"), a semi-solid beige-coloured paste (purity not given). At the intradermal induction stage, 0.5 ml test substance emulsified with 0.05ml Freund's adjuvant was injected s.c. (additional injections: 0.1 ml Freund's adjuvant alone + 0.1 ml test agent). Prior to injection, the test substance was diluted with water to 1% w/w. 6 days after injections, the skin at the treatment site was shaved once again and treated with 10% sodium lauryl sulfate to provoke an inflammatory reaction. 24 hours later, the treatment sites were occlusively covered with a 2 x 2 cm filter patch, saturated with 5% aqueous hydrogenated tallow alkylamines for 48 hours (topical induction). A 2% concentration of Amine HBG was selected for the final challenge. 14 days after the first challenge, the second challenge was performed (24h closed patch exposure). No positive responses were observed in the 10 induced and rechallenged animals (readings not given)

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: Guideline study according to GLP
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
slightly different grading system
GLP compliance:
yes (incl. QA statement)
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)
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
Route:
intradermal and epicutaneous
Vehicle:
cotton seed oil
Concentration / amount:
Induction, first stage, intradermal: 0.1%
Induction, second stage, topical: 1%
Challange: 0.5%
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
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)
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
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 chemical
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 chemical
Dose level:
0.5 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
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: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.5 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

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%.

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%.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Read across is made with hydrogenated tallow alkylamines inside the primary alkylamines category.

There are no valid human data available on sensitization for either the hydrogenated tallow alkylamines nor for any other alkylamines considered a chemical category within this chemical safety assessment. Animal data exist on hydrogenated tallow alkylamines from a Magnusson and Kligman maximisation according to OECD TG 405 test which demonstrated absence of a significant skin sensitizing potential, as well as from a GLP compliant MK maximisation test with C12 -18 -(even numbered)-alkylamines, which resulted also in an negative outcome. From both studies no significant skin sensitization potential of primary alkylamines is deducible. These data can be used in the assessment of hydrogenated tallow alkylamines, as well as for primary alkylamines in general. Additionally, since all primary alkylamines exhibite strong dermal irritative / corrosive properties, dermal exposure has to be limited anyway.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Read across is made with hydrogenated tallow alkylamines inside the primary alkylamines category.

Based on negative skin sensitization data available for hydrogenated tallow alkylamines as well as for other primary alkylamines, a respiratory sensitization potential of hydrogenated tallow alkylamines is not to be expected.

Justification for classification or non-classification

Read across is made with hydrogenated tallow alkylamines inside the primary alkylamines category.

Hydrogenated tallow alkylamines were tested for skin sensitization in a Maximization tests according to Magnusson and Kligman. Based on the results of this study, significant skin sensitizing properties have not been identified. Likewise, negative data regarding potential skin sensitization were also revealed with C12 -18 -(even numbered)-alkylamines. Based hereupon, classification of hydrogenated tallow alkylamines is not warranted.