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EC number: 221-336-6 | CAS number: 3069-29-2
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:
- 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:
- 1 988
- 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
- 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
- Reference substance name:
- N-[3-(dimethomethoxymethylsilyl)propyl]ethylenediamine
- IUPAC Name:
- N-[3-(dimethomethoxymethylsilyl)propyl]ethylenediamine
Constituent 1
Constituent 2
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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