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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report date:
1959

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Guinea Pig patch test
Principles of method if other than guideline:
Areas (ca. 25 cm2) on the right and left flank of the guinea pig are shaved and then greased. After 24 hours, the left flank is degreased with ether. A total of ca. 0.1 ml of the test material (20 % solution in acetone) is then applied in three consecutive applications. This application is repeated daily for 10 days, if necessary with larger amounts, until clear signs of irritation are observed on the treated skin area. Treatment is then discontinued until the signs of irritation have subsided (11 days). Both the left and right flank is then shaved again. The previosuly untreated right flank is then degreased with ether 24 hours later and treated once with a 2 % solution (in acetone) of the test substance. The skin reaction is scored 8, 12 and 24 hours after application.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Historical, In vivo study which was conducted before 1st June 2008

Test material

Constituent 1
Chemical structure
Reference substance name:
α,α'-propylenedinitrilodi-o-cresol
EC Number:
202-374-2
EC Name:
α,α'-propylenedinitrilodi-o-cresol
Cas Number:
94-91-7
Molecular formula:
C17H18N2O2
IUPAC Name:
α,α'-propylenedinitrilodi-o-cresol
Details on test material:
- Name of test material (as cited in study report): Metai.ldeaktivator DMD = NN' -Disalicyliden-1,2-Propandiamin
no further data

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: acetone
Concentration / amount:
20% test substance in acetone
Day(s)/duration:
10
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, open
Vehicle:
other: acetone
Concentration / amount:
2% test substance in acetone
Day(s)/duration:
10
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10
Details on study design:
Areas (ca. 25 cm2) on the right and left flank of the guinea pig are shaved and then greased. After 24 hours, the left flank is degreased with ether. A total of ca. 0.1 ml of the test material (20 % solution in acetone) is then applied in three consecutive applications. This application is repeated daily for 10 days, if necessary with larger amounts, until clear signs of irritation are observed on the treated skin area. Treatment is then discontinued until the signs of irritation have subsided (11 days). Both the left and right flank is then shaved again. The previosuly untreated right flank is then degreased with ether 24 hours later and treated once with a 2 % solution (in acetone) of the test substance. The skin reaction is scored 8, 12 and 24 hours after application.
Challenge controls:
no data
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2 %
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
erythema
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2 %
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Based on the available data, the test substance is considered a Skin sensitiser according to Regulation (EC) No 1272/2008 (CLP).