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Description of key information

Skin sensitisation


Test item is not a dermal sensitizer 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:
26 January 1982 - 16 April 1984
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
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:
guinea pig maximisation test
Justification for non-LLNA method:
in vivo study that was performed prior to current requirement for in vitro alternative testing
Specific details on test material used for the study:
TEST MATERIAL
- name as cited in test report: p-diisopropylbenzene
- Molecular weight: 162 g/mol
- Molecular formula: C12H18
- Physical state: liquid
- Boiling point: 208 °C at 760 mmHg

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability with H+; OH-; Heat, Light, H2: given
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 % as received
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
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:
other: not specified
Group:
positive control
Dose level:
not specified
Remarks on result:
other: not specified
Reading:
other: not specified
Group:
negative control
Dose level:
not specified
No. with + reactions:
0
Remarks on result:
other: not specified
Reading:
other: not specified
Group:
test chemical
Dose level:
not specified
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: not specified

The material did not elicit a positive response when administreed to ten guinea pigs in a standardized skin sensitization test. 

Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the results of this study, test item is not a dermal sensitizer in guinea pigs
Executive summary:

A skin sensitisation test was performed on guinea pigs. The material did no elicit a positive response when administered to ten guinea pigs in a standardized skin sensitization test.


Consequently, estimated human risk is low and 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 was performed on guinea pigs. The material did no elicit a positive response when administered to ten guinea pigs in a standardized skin sensitization test. Consequently, the test substance 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

According to the criteria of Classification, Labelling and Packaging of Substances and Mixtures Regulation (EC) No 1272/2008 (CLP Regulation), classification is not warranted for p-diisopropylbenzene.