Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Administrative data

Description of key information

non-sensitizing to the skin in guinea pigs

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
study performed in 1984, before the validation of the LLNA method
Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
other: acetone/dioxane/guinea pig fat (7:2:1)
Concentration / amount:
10% w/v in FCA
Route:
intradermal
Vehicle:
other: acetone/dioxane/guinea pig fat (7:2:1)
Concentration / amount:
10% w/v in FCA
Details on study design:
The Kodak methods employed both a) topical application of the test material in a unique solvent designed to enhance penetration and dermal absorption and b) subcutaneous injection of the material into the foot pad of the test guinea pigs. The solvent that was used was prepared in the laboratory and consisted of 70% acetone, 20% dioxane, and 10% guinea pig fat. The skin was also depilated prior to application to enhance contact and absorption. To stimulate the immune system, Freund’s Complete Adjuvant was injected into the guinea pig footpad.
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
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: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the results of this study, p-diisopropylbenzene is not a dermal sensitizer in guinea pigs
Executive summary:

In a Kodak standard dermal sensitization assay that is similar to the Buehler method, both topical and subcutaneous injections of test materials suspended or dissolved in agents known to stimulate the immune system. The Kodak method utilized ten guinea pigs that were treated by both a) topical application of the test material in a unique solvent designed to enhance penetration and dermal absorption and b) subcutaneous injection of the material into the foot pad of the test guinea pigs. The solvent that was used was prepared in the laboratory and consisted of 70% acetone, 20% dioxane, and 10% guinea pig fat. The skin was also depilated prior to application to enhance contact and absorption. To stimulate the immune system upon challenge, the test material was incorporated into Freund's Complete Adjuvant and was injected into the footpad of test animals. Following induction, animals were subjected to challenge with the test material that was evaluated 24 hours after exposure, wherein none of the test animals displayed evidence of dermal sensititization.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
other: Kodak method
Justification for non-LLNA method:
study performed in 1985, before the validation of the LLNA method
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
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 chemical
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.
Group:
positive control
Remarks on result:
not measured/tested
Remarks:
no information available
Interpretation of results:
GHS criteria not met
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:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
other: Kodak method
Justification for non-LLNA method:
study performed in 1985, before the validation of the LLNA method
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Route:
epicutaneous, occlusive
Vehicle:
other: 70% acetone+20% dioxane+10% guinea pig fat
Concentration / amount:
1% v/v
Route:
intradermal
Vehicle:
other: 70% acetone+20% dioxane+10% guinea pig fat
Concentration / amount:
10% v/v
No. of animals per dose:
10
Details on study design:
The Kodak test involved induction by application of 0.05 mL of a 1% solution of m-diisopropylbenzene in Freund's Complete Adjuvant (FCA). Prior to application, the skin was also depilated prior to application to enhance contact and absorption. Subsequently, animals were challenged by subcutaneous injection of a 10% v/v solution of the material into the foot pad of the test guinea pigs. The solvent that was used was prepared in the laboratory and consisted of 70% acetone, 20% dioxane, and 10% guinea pig fat.
Challenge controls:
Guinea pigs that were treated during the induction phase with FCA without test substance
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 chemical
Dose level:
10% 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: 10% v/v. No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance, m-diisopropylbenzene, is not sensitizing in guinea pigs
Executive summary:

The dermal application of 0.05 mL of a 1% solution of m-diisopropylbenzene in Freund's Complete Adjuvant (FCA) topically to guinea pigs produced slight to moderate erythema and slight edema after 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. At 24 hours, 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.

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

No study is available with DIPB (reaction mass of 1,3- and 1,4- isomers), but data are available on each isomer.

1,3 -DIPB:

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.

In a supporting study, the dermal application of 0.05 mL of a 1% solution of m-diisopropylbenzene in Freund's Complete Adjuvant (FCA) topically to guinea pigs produced slight to moderate erythema and slight edema after 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. At 24 hours, there was no evidence of sensitization in any of the test guinea pigs.

1,4 -DIPB:

In a Kodak standard dermal sensitization assay that is similar to the Buehler method, both topical and subcutaneous injections of test materials suspended or dissolved in agents known to stimulate the immune system. The Kodak method utilized ten guinea pigs that were treated by both a) topical application of the test material in a unique solvent designed to enhance penetration and dermal absorption and b) subcutaneous injection of the material into the foot pad of the test guinea pigs. The solvent that was used was prepared in the laboratory and consisted of 70% acetone, 20% dioxane, and 10% guinea pig fat. The skin was also depilated prior to application to enhance contact and absorption. To stimulate the immune system upon challenge, the test material was incorporated into Freund's Complete Adjuvant and was injected into the footpad of test animals. Following induction, animals were subjected to challenge with the test material that was evaluated 24 hours after exposure, wherein none of the test animals displayed evidence of dermal sensititization.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the classification criteria of UN/EU GHS, and given the absence of positive reactions in the available skin sensitisation data with 1,3 -DIPB and 1,4 -DIPB, DIPB (as a reaction mass of 1,3- and 1,4 -isomers) is not classified as a skin sensitizer.

No data are available for respiratory sensitisation; therefore no conclusion can be made on the classification of this endpoint.