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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
Study period:
23/02/2018 - 15/08/2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was initiated due to the requirements in a non-EU jurisdiction.

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-methoxyethoxy)ethyl methacrylate
EC Number:
256-190-2
EC Name:
2-(2-methoxyethoxy)ethyl methacrylate
Cas Number:
45103-58-0
Molecular formula:
C9H16O4
IUPAC Name:
2-(2-methoxyethoxy)ethyl 2-methylprop-2-enoate
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Animals were received from Elm Hill Breeding Labs, Chelmsford, MA on 10 Jan 2018, 24 Jan 2018, 27 Feb 2018. Following an acclimation period of at least five days, seventeen healthy male and nineteen healthy female non-pregnant and nulliparous Hartley Albino guinea pigs were assigned to the study without conscious bias.
The animals were born the on 25 Dec 2017, 08 Jan 2018, 11 Feb 2018. The pretest body weight range was 298 - 711 grams for males and 292 - 592 grams for females. The animals were identified by cage notation and a uniquely numbered metal eartag and housed one per cage in suspended wire-bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per
week. Fresh PMI Guinea Pig Chow (Diet No. 5025) and water were available ad libitum. The animal room, reserved exclusively for guinea pigs on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was kept clean and vermin free.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: FCA
Concentration / amount:
5%
Day(s)/duration:
7 days
Adequacy of induction:
other: Well-tolerated sytemically and did not cause local necrosis or ulceration
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
48 hours occlusion
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
24 hours occlusion, two weeks after Induction B
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
One group of 10 animals per sex served as the test article group. One group of five animals per sex
served as the control group.
Details on study design:
There are two stages to the maximization test. The first stage is the induction and consists of intradermal injections followed in seven days by a topical application of the test article. The second stage is the challenge which consists of a topical application performed 14 days following completion of the induction phase.
Challenge controls:
Acetone
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Abnormal physical signs including soiling, wetness, and/or yellow staining of the anogenital area were observed.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Abnormal physical signs including soiling, wetness, and/or yellow staining of the anogenital area were observed.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Soiling, and/or yellow staining of the anogenital area and bleeding from Site C, left side were observed in the vehicle control group.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Soiling, and/or yellow staining of the anogenital area and bleeding from Site C, left side were observed in the vehicle control group.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an OECD 406 study, conducted under GLP, 2-(2-methoxyethoxy)ethyl methacrylate is not a Dermal Sensitizer in the Guinea Pig.