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EC number: 252-558-1 | CAS number: 35435-21-3
Toxicological information
Skin sensitisation
Currently viewing:
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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- 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, which pre-dates the change of the REACH Regulation requirement for an LLNA skin sensitisation study from 2008.
Test material
- Reference substance name:
- Triethoxy(2,4,4-trimethylpentyl)silane
- EC Number:
- 252-558-1
- EC Name:
- Triethoxy(2,4,4-trimethylpentyl)silane
- Cas Number:
- 35435-21-3
- Molecular formula:
- C14H32O3Si
- IUPAC Name:
- triethoxy(2,4,4-trimethylpentyl)silane
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: No data
- Weight at study initiation: 300-500 g
- Housing:Groups in Terluran cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Described as 'adequate'
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 55 ±10
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- cotton seed oil
- Concentration / amount:
- Induction: Intradermal injection of 5% test substance
Induction: Topical exposure to 100% test substance
Challenge: 100% test substance
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- Induction: Intradermal injection of 5% test substance
Induction: Topical exposure to 100% test substance
Challenge: 100% test substance
- No. of animals per dose:
- Ten in test groups and five in negative control.
- Details on study design:
- RANGE FINDING TESTS: For the justification of the dose levels a preliminary test was performed. Four animals were topically treated with 25%, 50% or 100% of the test substance in cotton seed oil. No signs of irritation or systemic toxicity were recorded after a contact period of 48 hours after application of 100% concentration. Therefore the 100% concentration was chosen as the concentration for the topical and challenge exposures. For the justification of the first stage of the induction three animals were intradermally treated with 1%, 2.5% or 5% test substance. Slight erythema was found in the animals treated with 5%, until 48 hours after application. No signs were recorded at 72 hours. Therefore the concentration of 5% was chosen for the intradermal induction injection.
MAIN STUDY
A. INDUCTION EXPOSURE: intradermal injection
- No. of exposures: One
- Exposure period: Single injection
- Test groups: Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline (FCA). Injection 2: Test substance (5%). Injection 3: Prepared test substance at a concentration of 50% (v/v) in FCA, 1+1 (v/v) diluted with isotonic saline.
- Control group: Injection 1: FCA. Injection 2: Cotton seed oil. Injection 3: cotton seed oil at a concentration of 50% (v/v) FCA.
- Site: Shoulder region (Injections 1 and 2 close to each other and nearest the head. Injection 3 towards the caudal part of the test region).
B. INDUCTION EXPOSURE: topical application
- On Day 6, approximately 24 hours before the topical induction the test area, after close clipping, was painted with 0.5 ml of 10% sodium lauryl sulfate in vaseline, to create a local irritation.
- On Day 7, a patch saturated with either 0.5 ml 100% test substance (test group) or 0.5 ml of cotton seed oil (control group) was applied to the test site and held in contact by an occlusive dressing for 48 hours.
C. CHALLENGE EXPOSURE: topical
A patch saturated with 0.5 ml of the test substance (100%) was applied to the left flank of the animals. A patch saturated with 0.5 ml cotton seed oil was applied to the right flank. The patches were held in place with an occlusive dressing for 24 hours. At the end of the challenge period the skin was cleaned with moistened gauze patches. Skin reactions were assessed 24, 48 and 72 hours after removal of the dressings. - Challenge controls:
- POSITIVE CONTROLS: Mercaptobenzothiazole (10 animals): 2% for intradermal induction, 25% or topical induction and 15% for challenge.
NEGATIVE CONTROLS: cotton seed oil. - Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
Results and discussion
- Positive control results:
- 7 of 10 animals gave a positive result.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- 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:
- test chemical
- 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:
- negative control
- Dose level:
- cotton seed oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- cotton seed oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 15% Mercaptobenzothiazole
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 70% of the animals had skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 15% Mercaptobenzothiazole
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 70% of the animals had skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vivo skin sensitisation study, conducted according to OECD Test Guideline 406 and in compliance with GLP, triethoxy(2,4,4-trimethylpentyl)silane was concluded to be not sensitising to the skin.
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