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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:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Version / remarks:
1984
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4100 (Skin Sensitisation)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the guinea pig maximisation test method conducted in 1995

Test material

1
Chemical structure
Reference substance name:
-
EC Number:
419-560-6
EC Name:
-
Cas Number:
4369-14-6
Molecular formula:
C9H18O5Si
IUPAC Name:
3-(trimethoxysilyl)propyl prop-2-enoate
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: 32 females supplied by Charles River (UK) Ltd., Margate, Kent, UK. and 4 females by David Hall, Darley Oaks Farm, Newchurch, Burton-on-Trent, Staffs.
- Females nulliparous and non-pregnant: Not specified
- Microbiological status of animals, when known: Not specified
- Age at study initiation: 12 weeks old
- Weight at study initiation: 300-415 g
- Housing: Individually or in pairs
- Diet (e.g. ad libitum): Guinea Pig FD1 Diet, ad libitum
- Water (e.g. ad libitum): Mains tap water, ad libitum
- Acclimation period: At least 5 days
- Indication of any skin lesions: No skin lesions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 39-63
- Air changes (per hr): 15
- Photopersiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: See concentration / amount
Concentration / amount:
In test animals (shoulder region):
1) Freund's Complete Adjuvant plus distilled water in 1:1 ratio
2) A 1% w/v dilution of test material in arachis oiil
3) A 1% w/v dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus arachis oil
Day(s)/duration:
on study day 0 for 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
In test animals (same shoulder region), 100% undiluted test material
Day(s)/duration:
on study day 7 for 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
intradermal
Vehicle:
other: See concentration / amount
Concentration / amount:
In control animals (shoulder region):
1) Freund's Complete Adjuvant plus distilled water in 1:1 ratio
2) 100% arachis oil
3) 50% arachis oil in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water
Day(s)/duration:
on study day 0 for 48 hours
Adequacy of induction:
other: control animals with induction media as described
Route:
epicutaneous, semiocclusive
Vehicle:
other: See concentration / amount
Concentration / amount:
In control animals (same shoulder region), nothing was applied to the filter paper
Day(s)/duration:
on study day 7 for 48 hours
Adequacy of induction:
other: control animals as described
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: See concentration / amount
Concentration / amount:
In test animals:
1) 100% test substance applied on the shorn right flank
2) 75% test substance in arachis oil applied to a separate site on the shorn right flank
3) 100% arachis oil applied on the shorn left flank
Day(s)/duration:
on study day 21 for 24 hours
Adequacy of challenge:
other: Highest non-irritant test substance concentration (75-100%, two sites) plus a control (vehicle) site
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: See concentration / amount
Concentration / amount:
In control animals:
1) 100% test substance applied on the shorn right flank
2) 75% test substance in arachis oil applied to a separate site on the shorn right flank
3) 100% arachis oil applied on the shorn left flank
Day(s)/duration:
on study day 21 for 24 hours
Adequacy of challenge:
other: Highest non-irritant test substance concentration (75-100%, two sites) plus a control (vehicle) site
No. of animals per dose:
Test animals: 20F total, treatment sites as described in the induction and challenge tables above
Control animals: 10F total, treatment sites as described in the induction and challenge tables above
Details on study design:
RANGE FINDING TESTS: The concentrations used in the main study were selected based on the findings of a sighting test.
- Intradermal induction: Two animals were intradermally injected with 1% or 5% w/v test material in arachis oil. The highest concentration that did not cause local necrosis, ulceration or systemic toxicity was selected for the intradermal induction stage of the main study.
- Topical induction: The two animals subject to the intradermal induction, were also subject to topical induction 15 days later. At this time, the undiluted test material and preparations at 25%, 50% and 75% v/v concentrations in arachis oil were applied onto the skin for 48 hours under occlusive dressing. The highest concentration producing only mild to moderate dermal irritation were selected for the topical induction phase of the main study.
- Challenge phase: Two animals were subject to 48-hour occlusive topical challenge application of the undiluted test material and preparations at 25%, 50% and 75% v/v concentrations in arachis oil. The highest non-irritant concentration and one lower were selected for the challenge phase of the main study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injection followed by topical induction one week later)
- Exposure period: Not applicable for intradermal injections; 48 hours for topical induction phase
- Test groups: 20 test animals were treated as described in the induction table above
- Control group: 10 control animals were treated as described in the induction table above
- Site: Shoulder region, as described in the induction table above
- Frequency of applications: Intradermal injections on day 1 followed by topical induction on day 7
- Duration: Not applicable for intradermal injections; 48 hours for topical induction phase
- Concentrations: As described in the induction table above

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: One day of challenge application, performed on study day 21
- Exposure period: 24 hours
- Test groups: 20 animals were treated as described in the challenge table above
- Control groups: 10 animals were treated as described in the challenge table above
- Site: Flanks as described in the challenge table above
- Evaluation (hr after challenge): at 24, 48 and 72 hours
Challenge controls:
At challenge, the control animals were exposed to 100% test material in arachis oil, 75% test item in arachis oil, and 100% arachis oil. No erythema, oedema, or dermal reactions (except from patch removal) in the three control groups.
Positive control substance(s):
yes
Remarks:
a-hexylcinnamaldehyde, 2-mercaptobenzothiazole, ethyl-4-aminobenzoate, and 2,4-dinitrochlorobenzene; data collected November 1993 to November 1994

Results and discussion

Positive control results:
Based on positive control data from November 1993 to November 1994, the four positive controls yielded incidences of sensitisation as foillows:
* 7/10 for a-hexylcinnamaldehyde (tech 85%; undiluted and 75% in arachis oil)
* 8/10 for 2-mercaptobenzothiazole (purity not specified; 25% in 95% aqueous ethanol)
* 7/18 for ethyl-4-aminobenzoate (98%; 10% and 5% in 80% aqueous ethanol), and
* 9/9 for 2,4-dinitrochlorobenzene (purity not specified; 0.1% and 0.05% in arachis oil)

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Test animals
Dose level:
100% test substance
No. with + reactions:
14
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Test animals
Dose level:
100% test substance
No. with + reactions:
9
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Test animals
Dose level:
75% test substance in arachis oil
No. with + reactions:
14
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Test animals
Dose level:
75% test substance in arachis oil
No. with + reactions:
12
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Test animals (vehicle treatment)
Dose level:
100% arachis oil
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Test animals (vehicle treatment)
Dose level:
100% arachis oil
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Control animals
Dose level:
100% test substance
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Control animals
Dose level:
100% test substance
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Control animals
Dose level:
75% test substance in arachis oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Control animals
Dose level:
75% test substance in arachis oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: Control animals
Dose level:
100% arachis oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Control animals
Dose level:
100% arachis oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: not specified
Group:
other: Positive control data
Dose level:
a-hexylcinnamaldehyde (tech 85%), undiluted and 75% in arachis oil B.P
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: positive indication of skin sensitisation, positive control data from Nov 1993 to Nov 1994
Key result
Reading:
other: not specified
Group:
other: Positive control data
Dose level:
2-mercaptobenzothiazole, 25% in 95% aqueous ethanol
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: positive indication of skin sensitisation, positive control data collected Nov 1993 to Nov 1994
Key result
Reading:
other: not specified
Group:
other: Positive control data
Dose level:
ethyl-4-aminobenzoate (98%), 10% and 5% in 80% aqueous ethanol
No. with + reactions:
7
Total no. in group:
18
Remarks on result:
other: positive indication of skin sensitisation, positive control data collected Nov 1993 to Nov 1994
Key result
Reading:
other: not specified
Group:
other: Positive control data
Dose level:
2,4-dinitrochlorobenzene, 0.1% and 0.05% in arachis oil B.P
No. with + reactions:
9
Total no. in group:
9
Remarks on result:
other: positive indication of skin sensitisation, positive control data collected Nov 1993 to Nov 1994

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
This classification is consistent with Annex VI of Regulation (EC) No. 1272/2008.
Conclusions:
In the in vivo skin sensitisation study, conducted according to EPA OPP 81-6 (Skin Sensitisation; similar to OECD Test Guideline 406) and in compliance with GLP, 3-(trimethoxysilyl)propyl acrylate produced up to 70% sensitisation in guinea pigs treated with undiluted or 75% test substance in arachis oil.