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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:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was performed in 2007.

Test material

Constituent 1
Reference substance name:
L-Threonine, N-coco acyl derivs., monosodium salts
Cas Number:
90583-79-2
Molecular formula:
n/a
IUPAC Name:
L-Threonine, N-coco acyl derivs., monosodium salts
Test material form:
solid
Specific details on test material used for the study:
Name: Sodium Cocoyl Threoninate
BML-CODE: BML-10672
Lot No.: TCS-070717-3
Purity: 98% (w/w)
Impurities: Water (2% w/w)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
Original study in Japanese.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
0.5%
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5%
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1 or 0.5%
Adequacy of challenge:
not specified
No. of animals per dose:
Controls: 5 f
Test group: 10 f
Details on study design:
Intradermal induction: 0.5 % (w/w)
Epidermal induction: 5 % (w/w)
Challenge: 1, 0.5% (w/w)
Vehicle: Distilled water
Observation period: 24 and 48 hours after removal of the application patch
Challenge controls:
vehicle controls
Positive control substance(s):
yes
Remarks:
MBT

Results and discussion

Positive control results:
As expected all treated animals reacted positive

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 or 0.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 or 0.5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No indications for a skin sensitizing potential in guinea pigs
Executive summary:

A skin sensitization study was conducted in guinea pigs using the maximization method. Distilled water for injection was used as a vehicle control, and MBT was used as a positive control. No change was observed on the skin of the animals in the test item group following challenge, while skin reactions were observed in all animals of the positive control group.