Registration Dossier
Registration Dossier
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EC number: 627-085-2 | CAS number: 1238449-42-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1999-05-31 to 1999-04-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across (justification for read across see IUCLID chapter 13) GLP study OECD and EU guidelines were followed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Di-n-octylcarbonat
- IUPAC Name:
- Di-n-octylcarbonat
- Reference substance name:
- 1680-31-5
- EC Number:
- 605-498-9
- Cas Number:
- 1680-31-5
- IUPAC Name:
- 1680-31-5
- Test material form:
- other: liquid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Tierzucht Schönwalde GmbH; D-16352 Schönewalde
- Weight at study initiation: 312 and 387 g
- Housing: polycarbonate (macrolone type IV)
- Diet (e.g. ad libitum): free access to a pelleted diet "Altromin 3122"
- Water (e.g. ad libitum): fress access
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C +/- 3°C
- Humidity (%): 55 % +/- 15 %
- Air changes (per hr): 10 times/hour
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Vehicle:
- other: sesame oil
- Concentration / amount:
- - Inductions: approximately 100 % (undiluted)
- challenge: 75 %
Challengeopen allclose all
- Vehicle:
- other: sesame oil
- Concentration / amount:
- - Inductions: approximately 100 % (undiluted)
- challenge: 75 %
- No. of animals per dose:
- -Control: 10 animals
- Test group: 20 animals - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (on day 0,7 and 14)
- Exposure period: 6 hours
- Test groups: 1 group of 20 animals
- Control group: 1 group of 10 animals
- Site: left lank region
- Frequency of applications: 3 applications
- Duration: 6 hours
- Concentrations: 100 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: four weeks after the first induction (day 28)
- Test groups: 1 group of 20 animals
- Control group: 1 group of 10 animals
- Site: right flank region
- Concentrations: 75 %
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- The lated positive control study was performed from 29.03.1999 to 29.04.1999 in which 30 % of the animals responded positively.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- 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: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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