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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Landsteiner / Draize method
Principles of method if other than guideline:
The methods outlined by Landsteiner and Draize were followed. Ten intracutaneous injections were administered (3 per week for three weeks) followed by intradermal challenge two weeks after the last induction injection. A rechallenge was also applied one week later, applied to a naive site on the left untreated flank. Reactions were assessed 24 hours after each injection in the induction and challenge phases.
GLP compliance:
no
Remarks:
Conducted prior to development of GLP
Type of study:
intracutaneous test

Test material

Constituent 1
Chemical structure
Reference substance name:
4-isopropylbenzonitrile
EC Number:
237-492-3
EC Name:
4-isopropylbenzonitrile
Cas Number:
13816-33-6
Molecular formula:
C10H11N
IUPAC Name:
4-(propan-2-yl)benzonitrile
Test material form:
other: liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
The test animals were male albino guinea pigs, weighing from 192 to 246 g.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: 96% ethyl alcohol and 0.85% saline
Concentration / amount:
0.5% test substance (suspension 1:4 in 96% ethyl alcohol) in 0.85% saline. Injection volume was 0.05 mL.
Challengeopen allclose all
Route:
intradermal
Vehicle:
other: 96% ethyl alcohol and 0.85% saline
Concentration / amount:
0.5% test substance (suspension 1:4 in 96% ethyl alcohol) in 0.85% saline. Injection volume was 0.05 mL.
No. of animals per dose:
8

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: 1st challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
3
Total no. in group:
7
Clinical observations:
minimal to mild skin reaction
Remarks on result:
other: Reading: other: 1st challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 3.0. Total no. in groups: 7.0. Clinical observations: minimal to mild skin reaction.
Reading:
other: 2nd challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
2
Total no. in group:
7
Clinical observations:
minimal to mild skin reaction
Remarks on result:
other: Reading: other: 2nd challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 2.0. Total no. in groups: 7.0. Clinical observations: minimal to mild skin reaction.

Any other information on results incl. tables

One guinea pig in the test group died and two of the control animals also died. Death occurred during the induction phase and was attributed to severe diarrhoea rather than a direct effect of treatment.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: GHS EU
Conclusions:
From these result it may be concluded that no sensitization occured upon treatment with the test substance.