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Registration Dossier
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EC number: 271-729-1 | CAS number: 68606-18-8
Toxicological information
Skin sensitisation
Currently viewing:
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:
- weight of evidence
- Study period:
- 23 Mar 1993 - 30 Apr 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions. No details on positive control (reliability check) given.
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 details on positive control (reliability check) 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): only trade name given
- Chemical name: Heptanoic acid triglyceride
- Physical state: pale yellow liquid
- Analytical purity: 97.2%
- Date of production: September 29th, 1992
- Batch No.: 209052
- Expiration date of the lot/batch: October 1993 at the earliest
- Homogeneity: liquid appeared homogeneous on inspection
- Density (20 °C): 0.96 g/cm³
- Stability under test conditions: > 1 year
- Storage condition of test material: in a closed glass vessel in a laboratory hood
- Solubility (20°C): not soluble in water
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 ± 29 g
- Housing: conventional, 5 animals per cage in Makrolon Type IV
- Diet: Ssniff G 4 - Complete feed for guinea pigs (Ssniff, Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 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:
- Induction: 100%
Challenge: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Induction: 100%
Challenge: 100%
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
A preliminary test was conducted in order to establish a non-irritant test substance concentration which could be used in the main test. Amounts of 0.4 mL of test substance preparations (25, 50 and 75% (w/w) in corn oil) and the undiluted test substance were applied to the skin of 4 animals under occlusive conditions. Exposure duration was 6 h, after which the patches were removed and the areas of application were wiped off with corn oil and a cellulose swab. Dermal reactions were assessed directly after patch removal and 24 and 48 h post-application according to the Draize scoring system for erythema and edema.
The mean erythema and edema scores out of all 4 animals over 6, 24 and 48 h post-application were both 0.0. Thus, no primary dermal irritation was observed on the skin of the treated animals up to a test substance concentration of 100% at any reading time point. Therefore, the main study was performed using the undiluted test substance.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance
- Control group: corn oil
- Site: left flank
- Frequency of applications: every 7 days
- Duration: Days 0-14
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 h
- Test groups: test substance
- Control group: test substance
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 6, 24, 48 and 72 h after application of the test substance. - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- The sensitivity of the guinea pig strain used to reaction and effect of the known sensitiser 1-chloro-2,4-dinitrobenzene was stated to be checked at regular intervals (no further details provided).
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:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- 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:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
No test substance-related systemic effects were observed in the test or control animals. Body weight development was likewise not affected.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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