Registration Dossier
Registration Dossier
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EC number: 277-452-2 | CAS number: 73398-61-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- March 23rd, 1993 - April 30th, 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study with acceptable restrictions Lack of positive control data
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- , lack of positive control data
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Propane-1,2,3-triyl trisheptanoate
- EC Number:
- 210-647-2
- EC Name:
- Propane-1,2,3-triyl trisheptanoate
- Cas Number:
- 620-67-7
- IUPAC Name:
- propane-1,2,3-triyl triheptanoate
- Details on test material:
- - Name of test material (as cited in study report): Heptanoic Acid Trigylceride (Glycerol Triheptanoate)
- Physical state: homogeneous, pale yellow liquid
- Analytical purity: 97.2 area %
- Batch No.: 209052
- Water solubility: not soluble
- Stability: > 1 year
- Expiry date: Oktober 1993 at the earliest
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Dunkin Hartley, Pirbright White Bor: DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: 401 g +/- 29 g
- Housing: conventional, 5 animals per cage in Makrolon Type IV
- Diet (e.g. ad libitum): Ssniff G4 diet, Soest, Germany
- Water (e.g. ad libitum): tap water, Haltern, Germany
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % unchanged test substance for induction and challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % unchanged test substance for induction and challenge
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
25, 50, 75 and 100 % (w/w) of the test substance in corn oil were tested in 4 animals via topical application under occlusive conditions.
Exposure duration was 6 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20, TS
- Control group: 10, without TS
- Site: left flank
- Frequency of applications: on days 0, 7 and 14
- Duration: 6 h
- Concentrations: 100 % of the test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 28 (14 days after the third induction)
- Exposure period: 6 hours
- Test groups: 20, TS
- Control group: 10, TS
- Site: right flank
- Concentrations: 100 % of the test substance
- Evaluation (hr after challenge): 6, 24, 48 and 72 hours after application of the test substance. - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities
- 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. Clinical observations: no abnormalities.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities
- 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. Clinical observations: no abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information In a study performed according to OECD guideline 406 (Buehler), Glycerol Triheptanoate was not sensitising to the skin.
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