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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

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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:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler 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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
Hartley, Pinbright White Bor:DHPW [SPF]

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100%
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
100%
No. of animals per dose:
20 test animals and 10 control
Details on study design:
1st application: Induction 100 % occlusive epicutaneous
2nd application: Challenge 100 % occlusive epicutaneous

In the definitive test, a test group of 20 animals was induced with 100% test substance on days 0, 7 and 14 and subsequently challenged with 100% test substance on day 28. A control group of 10 animals was induced and challenged with MEH 56 corn oil.
Positive control substance(s):
yes
Remarks:
1-Chloro-2,4-dinitrobenzene

Results and discussion

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:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1-Chloro-2,4-dinitrobenzene
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1-Chloro-2,4-dinitrobenzene
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

There were no substance related effects or influence on body weight in either test or control animals. There was no erythema or edema observed during Induction Phases I, II or III; no skin irritation was observed in the control animals.
There was no skin irritation observed in either test or control animals in the Challenge Phase.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a guideline study (Buehler method), conducted in compliance with GLP, (3-chloropropyl)trimethoxysilane was not sensitising.