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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:
08/01/1988-12/02/1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according 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. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
EC Number:
221-336-6
EC Name:
N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
Cas Number:
3069-29-2
Molecular formula:
C8H22N2O2Si
IUPAC Name:
N-[3-[dimethoxy(methyl)silyl]propyl]ethane-1,2-diamine
Constituent 2
Reference substance name:
N-[3-(dimethomethoxymethylsilyl)propyl]ethylenediamine
IUPAC Name:
N-[3-(dimethomethoxymethylsilyl)propyl]ethylenediamine

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna (UK) Ltd., Wyton, Huntingdon, Cambridgeshire
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 315-395 g
- Housing:The animals were housed in groups of up to 4 in solid-floor polypropylene cages furnished with softwood shavings.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-23
- Humidity (%): 35-60
- Air changes (per hr): ca.15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
water
Concentration / amount:
INDUCTION: First exposure: a row of three injections (0.1 ml each), Freunds Complete Adjuvant plus distilled water in the ratio of 1:1, 0.1% (w/v) dilution of test material in distilled water, 0.1% (w/v) dilution of test material in a 1:1 preparation of Freud's Complete Adjuvant plus distilled water. Second exposure: undiluted test material.
CHALLENGE: undiluted
































































































Intradermal induction: 0.1% (w/v) in distilled water
Topical induction: undiluted as supplied
Topical challenge: undiluted as supplied
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
INDUCTION: First exposure: a row of three injections (0.1 ml each), Freunds Complete Adjuvant plus distilled water in the ratio of 1:1, 0.1% (w/v) dilution of test material in distilled water, 0.1% (w/v) dilution of test material in a 1:1 preparation of Freud's Complete Adjuvant plus distilled water. Second exposure: undiluted test material.
CHALLENGE: undiluted
































































































Intradermal induction: 0.1% (w/v) in distilled water
Topical induction: undiluted as supplied
Topical challenge: undiluted as supplied
No. of animals per dose:
20 (test), 10 (control) animals
Details on study design:
RANGE FINDING TESTS: The dose level for each of the three stages of the main study were determined using one or two guinea pigs and up to four dose levels tested on each animal.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: First exposure: a row of three injections (0.1ml each), Freunds Complete Adjuvant plus distilled water in the ratio of 1:1, 0.1% (w/v) dilution of test material in distilled water, 0.1% (w/v) dilution of test material in a 1:1 preparation of Freud's Complete Adjuvant plus distilled water. Second exposure: undiluted test material.
- Control group: identical to test group but without test material
- Site: shoulder region of each animal
- Exposure period: one week, followed by a 48-hour occlusive exposure.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2
- Site: right flank
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 and 48 hours

Positive control substance(s):
yes
Remarks:
Formaldehyde (40% aqueous solution)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
desquamation and thickening of skin
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
undiluted
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:
negative control
Dose level:
undiluted
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:
positive control
Dose level:
20% v/v
No. with + reactions:
17
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
20% v/v
No. with + reactions:
17
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
The test material is reported to be an extreme sensitiser to guinea pig skin in a study conducted according to OECD Test Guideline 406 and in compliance with GLP.

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