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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:
1985
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Liponate 2-DH CIR Report April 7, 2015
Author:
Cosmetic Ingredient Review
Year:
2015
Bibliographic source:
CIR Report April 7, 2015
Safety Assessment of PEG Diesters as Used in Cosmetics

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Remarks:
It's taken from the publication and the GLP compliance is not specified.
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study performed in 1985 before the LLNA method

Test material

Constituent 1
Reference substance name:
PEG-4 Diheptanoate
Molecular formula:
UVCB
IUPAC Name:
PEG-4 Diheptanoate
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: BC/DHA
Sex:
male
Details on test animals and environmental conditions:
10 male

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: dimethyl phthalate
Concentration / amount:
0.05 mL and 0.1 mL
Day(s)/duration:
5 weeks
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
intradermal and epicutaneous
Vehicle:
other: dimethyl phthalate
Concentration / amount:
0.05 mL
Day(s)/duration:
5 weeks
Adequacy of challenge:
not specified
No. of animals per dose:
10 guinea pigs at 0.05 mL and 0.1 mL
Details on study design:
The test substance was administered to the shaved skin of the shoulder of the guinea pigs followed 2 days later by an injection of dimethyl phthalate (1%; 0.1 mL).
Three more injections, 1 week apart, were administered to complete the induction phase. After a 13-day rest period, the challenge was administered as a topical administration of PEG-4 diheptanoate (5% or 50% in dimethyl phthalate; 0.05 mL) to the same shaven shoulder. The control consisted of a group of naïve guinea pigs (n=10) that were administered the challenge. Test sites were evaluated for reactions at 24 and 48 h after administration of the challenge.
Challenge controls:
yes
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.05 ml
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:
0.05 mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.05 mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.05 mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.05 mL
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:
negative control
Dose level:
0.05 mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0.05 mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0.05 mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.05 mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
not measured/tested
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.05 mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
not measured/tested
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Dose level:
0.05 mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
not measured/tested
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Dose level:
0.05 mL
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a dermal sensitization study using male BC/DHA guinea pigs (n=10), PEG-4 diheptanoate (5% or 25%; 0.05 mL in dimethyl phthalate) was not sensitizing when challenged at 5% or 50%.