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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:
Feb 12 - April 27, 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted July 17, 1992
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A LLNA study does not need to be conducted because adequate data from a OECD 406 skin senitisation study are available.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
454-780-6
EC Name:
-
Cas Number:
27445-54-1
Molecular formula:
Hill formula: C12H27NO2Si CAS formula: C12H27NO2Si
IUPAC Name:
Cyclohexyl-((diethoxy-methyl-silanyl)-methyl)-amine
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc : DH - guinea pigs (Full-Barrier)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
10/5 (test/control) Hsd Poc : DH - guinea pigs (Full-Barrier) , Sex: female, bodyweight at the commencement of the study 300 - 500 g.
5 (range finding) Hsd Poc : DH - guinea pigs (Full-Barrier) , Sex: female, nulliparous, nonpregnant, bodyweight at the commencement of the study 300 - 500 g.
A health inspection was performed to ensure the good state of health of the animals. The animals were derived from a controlled full barrier maintained breeding system (SPF). Source: Harlan Winkelmann GmbH, D-33178 Borchen.
According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
ANIMAL HUSBANDRY
The animals were barrier maintained (semi-barrier) in an air conditioned room
Temperature: 22 +/- 3°C
ReI. humidity: 55 +/- 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Feeding ad libitum, Altromin 3122 maintenance diet for guineapigs, rich in crude fiber, totally-pathogen-free (TPF)
Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
The animals were kept in groups in Terluran - cages on Altromin sawfiber bedding
Certificates of food, water and bedding are filed at BSL Bioservice
Adequate acclimatization period

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
0.5 % / 0.1 mL
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:
100%
Day(s)/duration:
2 days
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No. of animals per dose:
10
Details on study design:
Induction: First Stage, Intradermal Injection
Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region which was cleared of hair by clipping so that one of each pair lies on each side of the midline.
Test group: Day 0
Injection 1: Freund's Adjuvant complete, 1 + 1 (v/v) diluted with isotonic saline
Injection 2: Prepared Test item
Injection 3: Prepared Test item at a concentration of 50% (VN) 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 a concentration of50% (VN) 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.

Induction: Second Stage, Topical Application
Test and Control Group: Day 6
Approximately twenty-four hours before the topical induction application the test area, after close clipping was painted with 0.5 ml of 10% sodium lauryl sulphate in vaseline, in order to create a local irritation.
Test Group: Day 7
A patch was loaded with 0.5 ml of the 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 0.5 ml of the vehicle and applied to the test area and held in contact by an occlusive dressing for 48 hours.

Challenge: Topical Application
Test and Control Group: Day 20
A patch loaded with 0.5 ml of the test item was applied to the left flank of the animals and, a patch loaded with 0.5 ml vehicle to the right flank (intraspecific control), respectively. The patches were held in contact by an occlusive dressing for 24 hours.

Observation
Test and Control Group
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:
Mercaptobenzothiazole (15% in Vaseline)

Results and discussion

Positive control results:
The sensitization rate after application of the positive control substance Mercaptobenzothiazole (15% in Vaseline) was 80 %, confirming the reliability of the test system.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no treatment related effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no treatment related effects observed
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
15 % in vaseline
No. with + reactions:
8
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:
15 % in vaseline
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
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
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:
Considering the reported data of this sensitization test it can be stated that the test item caused no reactions identified as sensitization.
Executive summary:

A skin sensitization test according to OECD 406 was performed. Considering the reported data of this sensitization test it can be stated that the test item caused no reactions identified as sensitization.