Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

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
Reference substance name:
Reference substance 001
Cas Number:
121177-93-3
Details on test material:
- Name of test material (as cited in study report): Silane 434096 VP (CAS 121177-93-3)

- Physical state: colourless liquid

- Storage condition of test material: at room temperature protected from light

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, D-33178
- Weight at study initiation: 300-500 g
- Housing: the animals were barrier maintained (semi-barrier) in an air conditioned room, max 10 animals per cage
- Diet: Altromin 3122 maintenance diet for guinea pigs, rich in crude fibre, ad libitum
- Water: tap water, ad libitum
- Acclimation period: described as 'adequate'

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 55 +/-10
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
For the intradermal injection (induction - first stage) the test item was applied at a 5% concentration (diluted in corn oil). For the topical application (induction - second stage) the test item was applied as a 100% concentration. For the topical application (challenge) the test item was applied at a 100% concentration.
Challenge
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
For the intradermal injection (induction - first stage) the test item was applied at a 5% concentration (diluted in corn oil). For the topical application (induction - second stage) the test item was applied as a 100% concentration. For the topical application (challenge) the test item was applied at a 100% concentration.
No. of animals per dose:
10/5 (test/control)
Details on study design:
RANGE FINDING TESTS: For the justification of dose levels a preliminary test was performed. Two animals were intradermally treated with 1% and 5% concentration of the test item. For the 1% as well as the 5% concentration slight signs of erythema (grade 1) were recorded 24h as well as 48h after application. For both concentrations no signs of irritation and systemic toxicity were recorded at the 72 hours reading. Therefore the concentration of 5% was chosen for the intradermal induction. Two animals were topically treated with 50% as well as 100% for 24h and 48 hours, respectively. No signs of irritation and systemic toxicity were recorded during the observation time for the animals. Therefore the 100% concentration was chosen for the topical induction as well as for the challenge.

MAIN STUDY
A. INDUCTION EXPOSURE

FIRST STAGE, INTRADERMAL INJECTION
Test group: Day 0
Injection 1: Freund's Adjuvant Complete, 1+1 (v/v) diluted with isotonic saline
Injection 2: Prepared test item at a concentration of 50% (v/v) in Freund's Adjuvant Complete, 1+1 (v/v) diluted with isotonic saline

Control group: Day 0
Injection 1: Freund's Adjuvant Complete, 1+1 (v/v) diluted with isotonic saline
Injection 2: Vehicle
Injection 3: Vehicle at concentration of 50% (v/v) in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline

Injections 1 and 2 were given close to each other and nearest to the head, while 3 is given toward the caudal part of the test area.

SECOND STAGE, TOPICAL APPLICATION

Test and control group: Day 6
Approximately 24 hours before the topical induction application the test are, after close clipping, was painted with 0.5ml of 10% sodium lauryl sulfate in vaseline, in order to create a local irritation.

Test group: Day 7
A patch was loaded with 0.5ml of the prepared test item, applied to the test area and held in contact by an occlusive dressing for 48 hours.

Control group: Day 7
A patch was loaded with 0.5ml of the vehicle and applied to the test area and held in contact by an occlusive dressing for 48 hours.



B. CHALLENGE EXPOSURE

TOPICAL APPLICATION
The flanks of treated and control animals were cleared of hair by closely clipping and the use of depilation cream.

Test and control group: Day 20
A patch loaded with 0.5ml of the prepared test item was applied to the left flank of the animals and a patch loaded with 0.5ml vehicle tot he right flank (intraspecific control), respectively. The patched were held in contact by an occlusive dressing for 24 hours.

OBSERVATION

Approximately 21 hours after removing the patch the challenge area was cleaned and cleared of hair. Approximately 24 hours after removing of the patch the skin reaction was observed and recorded according to the grades shown below. Two more observations were recorded 48 and 72 hours after patch removal. Additionally all animals have been observed for signs of toxicity at least once daily during the test period.
Positive control substance(s):
yes
Remarks:
10% sodium lauryl sulfate in vaseline

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Mercaptobenzothiazole, 15% in vaseline
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Mercaptobenzothiazole, 15% in vaseline
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 and 100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 and 100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was found to be not sensitising to skin in the guinea pig maximisation test. The study was compliant with GLP.