Registration Dossier
Registration Dossier
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EC number: 202-374-2 | CAS number: 94-91-7
Skin sensitisation
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:
- 1 959
- 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
- 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
Constituent 1
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).
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