Registration Dossier

Administrative data

Description of key information

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
Reliability:
1 (reliable without restriction)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
other: Kodak method
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
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
No. of animals per dose:
10
Details on study design:
The Buehler test used three 6-hour applications of test substance at one-week intervals, followed by a challenge two weeks later.
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0% v/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100% v/v
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
The test substance, m-diisopropylbenzene, is not sensitizing in guinea pigs
Executive summary:

The sensitization potential of m-diisopropylbenzene was assessed in guinea pigs using a Buehler test design. Following 3 weekly applications of a 100% test substance, animals were challenged 2 weeks later by application of a 100% 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:

The potential for m-Diisopropylbenzene (m-DIPB) 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).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Justification for selection of respiratory sensitisation endpoint:
inhalation is not considered to be a relevant route of potential human exposure

Justification for classification or non-classification