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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The REACH regulation requires, according to Annex VII point 8.3 column 2, the performance of an LLNA study as the first choice method for in vivo sensitisation testing, at the same time suggesting that only in exceptional circumstances another test should be used (e.g. Magnusson and Kligman study (OECD 406)), for animal welfare reasons.
However, despite that the LLNA was developed as an alternative approach to the long established GPMT assay, its ability to discriminate between allergens and irritants is known to be limited. According to OECD 429 (24th April 2002): “Despite the advantages of the LLNA over traditional guinea pig tests, it should be recognised that there are certain limitations that may necessitate the use of traditional guinea pigs tests (e.g., false negative findings in the LLNA with certain metals, false positive findings with certain skin irritants).
The substance N-phenylacrylamide (CAS: 2210-24-4) is a solid organic substance (melting point 105°C) and is classified as irritating to skin (according to regulation (EC) No.: 1272/2008: Category 2, H315: Causes skin irritation). Based on the fact that certain skin irritants gave false positive findings in the LLNA (standard procedure), it was decided to conduct the more robust Magnusson and Kligman study instead of the Local Lymph Node Assay, to avoid any interference of potential skin irritating effects on the overall assay outcome.
In conclusion, N-phenylacrylamide was found to be not sensitising to guinea pigs in a test model according to the MAGNUSSON and KLIGMAN method and must not be classified according to regulation (EC) No.: 1272/2008.

Test material

Constituent 1
Chemical structure
Reference substance name:
N-phenylprop-2-enamide
EC Number:
606-936-1
Cas Number:
2210-24-4
Molecular formula:
C9 H9 N O
IUPAC Name:
N-phenylprop-2-enamide

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Induction
Route:
other: first by intracutaneous application (shoulder region) and 7 days later by topical administration (shoulder region)
Vehicle:
other: sesame oil
Concentration / amount:
10% suspension for the 1st (intracutaneous) induction stage, 75% suspensions for the 2nd (topical) induction stage and for the challenge
Challenge
Route:
other: topical (flank region)
Vehicle:
other: sesame oil
Concentration / amount:
10% suspension for the 1st (intracutaneous) induction stage, 75% suspensions for the 2nd (topical) induction stage and for the challenge
No. of animals per dose:
15 (5 for vehicle control and 5 for test item)
20 (for positive control, obtained from the historical background of this test laboratory)
Positive control substance(s):
yes
Remarks:
alfa-hexyl cinnamic aldehyde

Results and discussion

Positive control results:
Animals of the same strain treated with alfa-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema (grade 2) or a discrete or patchy erythema (grade 1).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: both flanks
Hours after challenge:
48
Group:
test chemical
Dose level:
highest dose level
No. with + reactions:
0
Total no. in group:
10
Reading:
other: both flanks
Hours after challenge:
72
Group:
test chemical
Dose level:
highest dose level
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
highest dose level
Reading:
other: both flanks
Hours after challenge:
48
Group:
negative control
Dose level:
no test substance
No. with + reactions:
0
Total no. in group:
5
Reading:
other: both flanks
Hours after challenge:
72
Group:
negative control
Dose level:
no test substance
No. with + reactions:
0
Total no. in group:
5
Reading:
other: left flank
Hours after challenge:
48
Group:
positive control
Dose level:
alfa-hexyl cinnamic aldehyde
No. with + reactions:
20
Total no. in group:
20
Reading:
other: right flank
Hours after challenge:
48
Group:
positive control
Dose level:
alfa-hexyl cinnamic aldehyde
No. with + reactions:
0
Total no. in group:
20
Reading:
other: left flank
Hours after challenge:
72
Group:
positive control
Dose level:
alfa-hexyl cinnamic aldehyde
No. with + reactions:
13
Total no. in group:
20
Reading:
other: right flank
Hours after challenge:
72
Group:
positive control
Dose level:
alfa-hexyl cinnamic aldehyde
No. with + reactions:
0
Total no. in group:
20

Any other information on results incl. tables

Body weight gain was within the range of the vehicle control during the experiment.

No necropsy was performed. No animal was found dead or was sacrificed in extremis during the study.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
Skin sensitisation potential of CH03859 was determined using the OECD 406 protocol (guinea pig maximisation test). No skin sensitisation was observed for any of the guinea pigs in the study. Therefore, CH03859 does not need to be classified for skin sensitisation.