Registration Dossier
Registration Dossier
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EC number: 202-576-0 | CAS number: 97-36-9
Skin sensitisation
Administrative data
- 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:
- other: well performed OECD and GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2',4'-dimethylacetoacetanilide
- EC Number:
- 202-576-0
- EC Name:
- 2',4'-dimethylacetoacetanilide
- Cas Number:
- 97-36-9
- Molecular formula:
- C12H15NO2
- IUPAC Name:
- 2',4'-dimethylacetoacetanilide
- Details on test material:
- - Name of test material (as cited in study report): Acetessig-m-Xylidid TF
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White Hoe: DHPK(SPFLac)
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Hoechst AG, Kastengrund, SPF breed
- Weight: mean: 294 g (260 g - 344 g, n=15)
- Randomisation: acc. to plan No 390/88
- Housing: in air conditioned rooms, groups of 5 animals
- Temperature: 22 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Artificial light: 12 hrs daily
- Acclimatisation: min 5 days
- Diet: Altromin 3112, ad libitum
- Water: tap water in plastic bottels, ad libitum
- Labelling: Numbering of cages as well as labelling of pelt with KMnO4
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: paraffin (DAB), petrolatum (DAB)
- Concentration / amount:
- Intradermal induction treatment:
1.0 % test substance in paraffin (DAB) and 1.0 % test substance in 50% Freund's adjuvants
Epicutaneous induction treatment:
2.5 % test substance in petrolatum (DAB)
Epicutaneous challange exposure:
0.25 % test substance in petrolatum (DAB)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: paraffin (DAB), petrolatum (DAB)
- Concentration / amount:
- Intradermal induction treatment:
1.0 % test substance in paraffin (DAB) and 1.0 % test substance in 50% Freund's adjuvants
Epicutaneous induction treatment:
2.5 % test substance in petrolatum (DAB)
Epicutaneous challange exposure:
0.25 % test substance in petrolatum (DAB)
- No. of animals per dose:
- 5 animals in control group, 10 animals in treatment group
in the case of equivocal results a double number of test animals is scheduled
historical laboratory data show, that the initial number of animals usually is sufficient to come to a final conclusion - Details on study design:
- - Study day 1: Intradermal induction exposure
- Study day 9: Epicutaneous induction exposure
- Study day 22: Epicutaneous challenge exposure
- Study day 24: 1st reading
- Study day 25: 2nd reading
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- intradermal induction 0%, epicutaneous induction 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- without abnormal findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: intradermal induction 0%, epicutaneous induction 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: without abnormal findings.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction 1%, epicutaneous induction 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- without abnormal findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: intradermal induction 1%, epicutaneous induction 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: without abnormal findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- intradermal induction 0%, epicutaneous induction 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- without abnormal findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: intradermal induction 0%, epicutaneous induction 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: without abnormal findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- intradermal induction 1%, epicutaneous induction 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- without abnormal findings
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: intradermal induction 1%, epicutaneous induction 2.5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: without abnormal findings.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on these findings the test substance was considered not to be a skin sensitiser.
- Executive summary:
The test item was tested for skin sensitising properties in a guinea pig maximisation test. Intradermal induction treatment was done with a 1% concentration of the test item in paraffin, epicutaneous induction treatment was done using a 2.5% concentration of the test item in petrolatum. Dermal challenge treatment was done using a 0.25% concentration of the test item in petrolatum. Neither animals of the control group nor animals of the dose group showed a skin response after challenge treatment. Based on these findings the test substance was considered not to be a skin sensitiser.
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