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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:
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.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Test guideline
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)

Test material

Constituent 1
Reference substance name:
Amines, hydrogenated tallow alkyl
EC Number:
262-976-6
EC Name:
Amines, hydrogenated tallow alkyl
Cas Number:
61788-45-2
IUPAC Name:
61788-45-2
Constituent 2
Reference substance name:
Hydrogenated Tallow Alkylamines
IUPAC Name:
Hydrogenated Tallow Alkylamines
Details on test material:
- Name of test material (as cited in study report): Stearylamine (Amine HBG)

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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.
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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)