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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:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out in accordance with an appropriate OECD test guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Label Identification: Dow Corning® 1-6376 Alkoxysilane
Lot Number: PE034001
Physical Characteristics: Clear liquid
Purity: No correction necessary
Shelf Life/Expiration Data: June 1997
Storage: Room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Crl: (HA)BR
Sex:
male
Details on test animals and environmental conditions:
The animals were housed in individual hanging stainless steel wire mesh cages in an animal room with controlled temperature (70-73 °F = 21.1 - 22.8 °C ), humidity (45-56%) and light (12hours light and 12 hours dark). Diet (Certified Guinea Pig Chow® #5026, Purina Mills, Inc., St. Louis, Missouri) and water were free available. The animals were acclimated for 16 days prior to the first induction dose. Male animals free from physical abnormalities and of the appropriate body weight range were made available for selection and were placed into groups using a computer-generated random number sequence program. Each guinea pig was identified by a Monel® metal ear tag bearing the individual animal number. The body weight range of the day of intradermal injections was 408-533 grams. The guinea pigs were young adult animals, approximately 1 ½ months of age at the start of the study.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
cotton seed oil
Concentration / amount:
Induction: Intradermal injection: 5%
Induction: Epicutaneous patch: 75%
Challenge: Epicutaneous patch 75%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
cotton seed oil
Concentration / amount:
Induction: Intradermal injection: 5%
Induction: Epicutaneous patch: 75%
Challenge: Epicutaneous patch 75%
No. of animals per dose:
20 males in test article-treated group
10 males in negative control group
10 males in positive control group
Details on study design:
The definitive sensitization maximization test consisted of an Induction Phase (intradermal injections and topical applications of the test article to stimulate the immune system) and a Challenge Phase (a single topical application of the test article to determine if delayed contact hypersensitivity had occurred). During the intradermal induction stage, the test group of 20 animals were dosed intradermally with duplicate injections of 1:1 FCA:saline, a 5% w/v mixture of Dow Corning® 1-6376 Alkoxysilane in cottonseed oil and a 5% w/v mixture of Dow Corning® 1-6376 Alkoxysilane in 1:1 FCA:saline. The negative control group of ten animals were injected with 1:1 FCA:saline, undiluted cottonseed oil and a 50% w/v mixture of cottonseed oil in 1:1 FCA:saline. The positive control group of ten animals was injected with 1:1 FCA:saline, a 0.1% w/v mixture of 2,4-DNCB in 80% ethanol and a 0.1% w/v mixture of 2,4-DNCB in 1:1 FCA:saline. One week after the intradermal injections, the area was clipped free of hair and treated with 10% sodium lauryl sulfate (SLS) in distilled water in order to enhance sensitization. On the day following the SLS application, a patch saturated with 75% test article in cottonseed oil or control articles (negative group was topically induced with cottonseed oil neat; positive controls were topically induced with a 0.5% w/v concentration of 2,4-DNCB in petrolatum) was applied to the injection area of treated and control animals, respectively, and covered with an occlusive dressing for 48 hours. On the day prior to challenge dosing, the flanks of each guinea pig were clipped free of hair. Fourteen days after topical induction on study day 22, all test article and negative control animals were challenged with 75% w/v mixture of Dow Corning® 1-6376 Alkoxysilane in cottonseed oil on the anterior left flank and the vehicle, cottonseed oil, on the anterior right flank. Positive control group animals received a topical challenge dose of a 0.25% w/v solution of 2,4-DNCB in petrolatum on the anterior left flank and the vehicle, petrolatum, on the anterior right flank. All challenge doses were applied on previously unexposed areas of skin. The patches were occluded with plastic wrap and over wrapped with tape for 24 hours. Twenty-four hours after dosing, the occlusive cover was removed and the sites washed with tepid water. Application sites were evaluated at approximately 24 and 48 hours after patch removal. Sites were graded on a scale of 0 to 4 for both erythema/eschar formation and edema formation. During the test animals were observed twice daily for mortality. Individual body weights were recorded prior to intradermal injection and at a study termination.
Challenge controls:
Details provided above
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75% test article
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75% test article. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
vehicle (cottonseed oil)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle (cottonseed oil). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75% test article
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75% test article. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
vehicle (cottonseed oil)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle (cottonseed oil). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75% test article
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75% test article. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle (cottonseed oil)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle (cottonseed oil). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75% test article
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75% test article. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle (cottonseed oil)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle (cottonseed oil). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.25% 2,4-DNCB
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.25% 2,4-DNCB. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
vehicle (petrolatum)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: vehicle (petrolatum). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.25% 2,4-DNCB
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.25% 2,4-DNCB. No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
vehicle (petrolatum)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: vehicle (petrolatum). No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the conditions of this test, no animals exhibited a sensitization response to Dow Corning® 1-6376 Alkoxysilane.