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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation (Buehler method)


Similar to OECD guideline 406, not sensitizing in guinea pigs

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo study that was performed prior to current requirement for in vitro alternative testing
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 JUL 1985 - 20 DEC 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
only 10 animals tested, not many details provided in the report
Principles of method if other than guideline:
only 10 animals tested, not many details provided in the report
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
in vivo study that was performed prior to current requirement for in vitro alternative testing
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 324 - 415g
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
100% as received
Day(s)/duration:
3 weekly doses
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
100% as received
Day(s)/duration:
not specified
No. of animals per dose:
10
Details on study design:
no details given
Positive control substance(s):
no
Reading:
1st reading
Group:
negative control
Dose level:
0% v/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Hours after challenge is not indicated
Reading:
1st reading
Group:
test chemical
Dose level:
100% v/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Hours after challenge is not indicated . Doesn't show irritating sign
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Preliminary tests had shown this material to be irritating to the abdomen, but not the backs of guinea pigs. During the course of the test, no irritation was observed during the induction phase using 100 % compound, so animals were challenged with the compound as received as well.

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not sensitizing in guinea pigs
Executive summary:

A skin sensitisation test (Buehler method) was performed on guinea pigs. The test was done similar to OECD guideline 406. The sensitization potential of test item was assessed in guinea pigs using a Buehler test design. In the induction phase animals received 3 weekly applications of 100% of the test substance. Challenge was also performed with 100 % of the test substance. There were no signs of sensitization in any of the test animals. Consequently, the test substance was determined to be non-sensitizing in guinea pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation, Buehler method


A skin sensitisation test (Buehler method; Key study) was performed on guinea pigs. The test was done similar to OECD guideline 406. The sensitization potential of test item was assessed in guinea pigs using a Buehler test design. In the induction phase animals received 3 weekly applications of 100 % of the test substance. Challenge was also performed with 100 % of the test substance. There were no signs of sensitization in any of the test animals. Consequently, the test substance was determined to be non-sensitizing in guinea pigs.


 


Skin sensitisation, Kodak method


The skin sensitisation test (Kodak method; Supporting study) was performed on guinea pigs. The dermal application of 0.05 mL of a 1 % solution of test item in Freund's Complete Adjuvant (FCA) topically to guinea pigs produced slight to moderate erythema and slight edema for 1 -3 days. Animals were subsequently challenged by subcutaneous injection of a 10 % v/v solution of the material into the foot pad of the test guinea pigs. There was no evidence of sensitization in any of the test guinea pigs. Consequently, m-diisopropylbenzene was determined to be non-sensitizing in guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

respiratory sensitisation
inhalation is not considered to be a relevant route of potential human exposure

Justification for classification or non-classification

The potential for m-diisopropylbenzene to induce skin sensitization was assessed in two independent studies, which utilized either the Buehler method or a variation of the Magnusson Kligmann maximization method. In both studies, there was no evidence of skin sensitization observed, and therefore, m-DIPB does not satisfy the criteria for classification as a dermal irritant according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).