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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1987-11-04 to 1987-12-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate test method and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 406/2
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Disilan M 6
- Molecular formula: (CH3)3 SiSi (CH3)3
- Physical state:b colorless clear aqueous liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature in the dark
- Other: Test substance supplier: Wacker-Chemie GmbH, München; Density: 0.72 g/ml; pH 6.9

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Strain: Pirbright; Substrain: Hoe: DHPK (SPF - LAC.)/Boe
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht; Hagemann GmbH & Co. KG; Hamelner Straße 3; 4923 Extertal 1; Germany
- Age at study initiation: no data
- Weight at study initiation: 294 - 366 g
- Housing: max. 5 animals/cage; Makrolon IV, H 20 cm, W 33 cm, T 55 cm
- Diet (e.g. ad libitum): Ssniff-G^R (Pellets), no data about access and amount
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C ± 2°C
- Humidity (%): 50 - 85%
- Photoperiod (hrs dark / hrs light): 12 h daily, 7 a.m. to 7 p.m. ; artificial light

Others: litter was sterilized

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Oleum arachidis
Concentration / amount:
0.5 ml of the test substance. The 1st and 2nd induction was treated with the 100% . The 3rd induction with 50% (vehicle Oleum arachidis)
Challenge with 75% (vehicle Oleum arachidis)
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: Oleum arachidis
Concentration / amount:
0.5 ml of the test substance. The 1st and 2nd induction was treated with the 100% . The 3rd induction with 50% (vehicle Oleum arachidis)
Challenge with 75% (vehicle Oleum arachidis)
No. of animals per dose:
10 males and 10 females in the treatment groups
5 males and 5 females in the control group
Details on study design:
RANGE FINDING TESTS:
To exclude primary skin irritation 2 guinea pigs each concentration (0.5 ml (g)/animal) were treated with a single dermal occlusive treatment: 100%, 75% and 50% dilution in Oleum arachidis

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: after 6 h the substance was removed with tepid tap water
- Test groups: 1
- Control group:1
- Site: upper left flank, clipped, approximately 5 x 4 cm
- Frequency of applications: once weekly
- Concentrations: 1.and 2. exposure with 100% of the test substance (0.5 ml (g)/animal), 3. exposure 50% dilution of the test substance in Oleum arachidis (0.5 ml (g)/animal)

B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge: challenge exposure 14 days following last induction
- Exposure period: 48 h
- Test groups: as above
- Control group: as above
- Site: below the induction area
- Concentrations: exposure with 75% of the test substance in Oleum arachidis (0.5 ml (g)/animal)
- Evaluation (hr after challenge): after 24 h the exposure site were depilated and 2 h after any skin lesions were evaluated (24 h value), the second evaluation was after further 24 h (48-value)

Challenge controls:
75%
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75%
No. with + reactions:
12
Total no. in group:
20
Clinical observations:
9 with slight patchy erythema; 3 with slight, confluent or moderate patchy erythema
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: 9 with slight patchy erythema; 3 with slight, confluent or moderate patchy erythema .
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75%
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
5 with slight patchy erythema; 1 with slight, confluent or moderate patchy erythema
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: 5 with slight patchy erythema; 1 with slight, confluent or moderate patchy erythema .

Any other information on results incl. tables

Range finding:

 sex dose   24 h  48 h  animal nr.
 m  100%  ±  0  1
 w  100%  0  0  2
 m  75%  0  0  1
 75%  0  0  2
 m  50%  0  0  1
 w  50%  0  0  2

Summary of the mean values / challange

 group  number/sex  dose  24h  48h
 control 5 m + 5 w  75%   0
 treatment 10 m + 10 w  75%   0.38 0.18 

Scale of the evaluation:

0 = no reaction

0.5 = ± slight, patchy erythema

1 = slight, confluent or moderate patchy erythema

2 = moderate erythema

3 = severe erythema or edema

After two induction treatments (test substance 100%) some of the test animals showed partly moderate to severe erythema. Therefore, the 3rd induction treatment was performed with a 50% dilution, which caused no primary skin irritation. 24 hours after the challenge treatment (test substance 75%) slight patchy erythema was observed in the test animals (12/20). After 48 hours the symptoms were significantly reduced (6/20). However, since this concentration was used in the challenge in the range finding test, no primary skin irritation was caused and also there were no findings in the control group in the challenge, it was assumed by the study authors that this is a sensitizing effect.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: According to the method modified by E. V. Buehler the substance
Executive summary:
To test the sensitizing properties of "Disilane M 6", 20 Pirbright-guinea pigs for the test group and 10 guinea pigs were used for the control group.
During the induction phase t
he substance was dermally applied 1 x weekly to the skin of the test animals.14 days after the last treatment the challenge
was followed for the test and control animals.
Any reaction, especially erythema was evaluated 24 and 48 h after the challenge. According to the modified method according E. V. Buehler the substance "Disilane M 6" (Faß 7) (Hexamethyldisilane) is classified as sensitizing.