Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994 - 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
study performed in 1994 - 1995

Test material

Constituent 1
Reference substance name:
Wheat protein hydrolyzate
IUPAC Name:
Wheat protein hydrolyzate
Test material form:
liquid

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

No. of animals per dose:
20 (treatment) + 10 (controls) + 8 (preliminary study)
Details on study design:
A specific brand of HWP in a test concentration of 50% in water was used for induction and challenge. (Induction with HWP was performed in 20 animals, 10 animals were controls). Preliminary irritation tests and dose-finding to establish the appropriate concentration of the test substance to induce sensitization were performed in 8 animals.
Challenge controls:
10 animals
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0,5 ml of 50% solution
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
slight patchy erythema
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0,5 ml of 50% solution
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0,5 ml of 50% solution
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
slight patchy erythema
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0,5 ml of 50% solution
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
slight patchy erythema

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
substance is not sensitizinig
Executive summary:

In order to cross-link IgE in sensitised individuals, a protein needs to have a minimum size which is assumed to be in the order of 3 kDa (Huby 2000). It can be argued that proteins of this size are also unlikely to induce clinically relevant (type I) sensitisation. The CIR Expert Panel concluded that HWP is safe for use in cosmetics when formulated to restrict peptides to a weight average MW of 3.5 kDa or less (CIR (2014).