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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:
December 18, 1990 - June 24, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))
EC Number:
406-420-4
EC Name:
α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))
Cas Number:
69430-40-6
Molecular formula:
Unspecified example: C18.3H46.8O5.8Si4.1
IUPAC Name:
α-trimethylsilanyl-ω-trimethylsiloxypoly[oxy(methyl-3-(2-(2-methoxypropoxy)propoxy)propylsilanediyl]-co-oxy(dimethylsilane))
Details on test material:
- Name of test material (as cited in study report): DC 5067
- Substance type: Reaction mass (mixture)
- Physical state: Liquid
- Analytical purity: > 99%
- Lot/batch No.: AB 090122
- Expiration date of the lot/batch: December 1, 1991
- Stability under test conditions: Stable
- Storage condition of test material: In the original container at room temperature in the dark
- Other:

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Intradermal induction: 2.5% w/w in propylene glycol
Epidermal induction: 50% w/w in propylene glycol
Challenge:
a = 10% (w/w) in propylene glycol
b = 3% (w/w) in propylene glycol
c = 1% (w/w) in propylene glycol
d = propylene glycol
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Intradermal induction: 2.5% w/w in propylene glycol
Epidermal induction: 50% w/w in propylene glycol
Challenge:
a = 10% (w/w) in propylene glycol
b = 3% (w/w) in propylene glycol
c = 1% (w/w) in propylene glycol
d = propylene glycol
No. of animals per dose:
Experimental group: 20 (females)
Control group: 10 (females)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
redness, swelling and/or scaliness
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: redness, swelling and/or scaliness.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
redness, swelling and/or scaliness
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: redness, swelling and/or scaliness.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
redness, swelling and/or scaliness
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: redness, swelling and/or scaliness.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
redness, swelling and/or scaliness
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: redness, swelling and/or scaliness.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no skin reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reaction.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no skin reaction
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reaction.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no skin reaction
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reaction.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no skin reaction
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin reaction.

Any other information on results incl. tables

PRIMARY IRRITATION EXPERIMENTS

No signs of systemic toxicity were observed during the primary irritation experiments. However body weight loss was noted in one of the five animals. The choice of propylene glycol as vehicle in this test was based on the following: - the test substance dissolved well in propylene glycol at the concentrations used. - the test substance is stable in propylene glycol.

In accordance with Magnusson and Kligman (1969), based on the findings in the primary irritation experiments and from the test substance concentrations tested in the first inconclusive Maximization Test, the following concentrations were selected for the induction and challenge phase:

Intradermal induction: 50% (w/w) in propylene glycol

Challenge:       a = 10% (w/w) in propylene glycol

b = 3% (w/w) in propylene propylene

c = 1% (w/w) in propylene glycol

d = propylene glycol

MAIN STUDY

INDUCTION All experimental animals showed slight or moderate erythema and slight oedema after the 48 hours occluded epidermal induction exposure.

FIRST CHALLENGE

CONTROL GROUP:

All ten animals showed a skin reaction in response to the 10% test substance concentration. These skin reactions were characterised by redness, swelling and/or scaliness. No skin reactions were observed in response to the 3% and 1% concentrations.

EXPERIMENTAL GROUP:

Fourteen, four and four animals showed a skin reaction in response to the l0%, 3% and 1% test substance concentrations. These reactions were characterised by redness, swelling and/or scaliness (see table 3, Appendix 1). Taking into account the intensity of the responses and comparing these with the reactions seen in the control animals, four of the animals showed a positive skin reaction in response to the 3% and 1% concentrations. No animals showed a positive skin reaction in response to the 10% concentration.

TOXICITY SYMPTOMS / MORTALITY

No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study.

BODY WEIGHTS

A marked difference in the average body weight gain of experimental and control animals was noted.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information mild sensitizing properties
Conclusions:
These results lead to a sensitisation rate of 20 per cent, which indicates that DC-5067 has mild sensitizing properties in this test applying the rating of allergenicity described by Kligman A.M. (1966).
Executive summary:

The study was entitled "Assessment for Contact Hypersensitivity to DC-5067 in the Albino Guinea Pig (Maximization Test)". The purpose of the study was to obtain information on the potential of DC-5067 to induce delayed contact hypersensitivity (skin sensitization) in the guinea pig after intradermal and epidermal exposures. This study was carried out in accordance with the OECD Guideline Number 406 and in accordance with the method described by Magnusson and Klingman. The experimental animals were intradermally injected with a 2.5% concentration and epidermally exposed with a 50% concentration. Two weeks after the epidermal application all animals were challenged with the following test substance concentrations (10%, 3% and 1%) and the vehicle (propylene glycol). The epidermal exposure of DC-5067 in the introduction phase resulted in slight to moderate skin irritation. The epidermal exposure of DC-5067 in the challenge phase resulted in four positive sensitization reactions in response to the 3% and 1% test substance concentrations. Under the conditions used in this study, DC-5067 resulted in a sensitization rate of 20%. Applying the rating of allergenicity described by Klingman, A. M. (-1966) on the results obtained in this test, DC-5067 is considered to have mild sensitizing properties. Applying the EEC criteria-for classification, DC-5067 need not be labeled as a skin sensitizer.