Registration Dossier
Registration Dossier
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EC number: 700-672-1 | CAS number: 70226-26-5
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
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with restrictions. Group sizes to small and lack of positive control data (no reliability check).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- study performed according to a modified Buehler Test, group sizes too small, lack of positive control data and no reliability check
- GLP compliance:
- no
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 2,3-dihydroxypropyl laurate
- EC Number:
- 205-526-6
- EC Name:
- 2,3-dihydroxypropyl laurate
- Cas Number:
- 142-18-7
- Molecular formula:
- C15H30O4
- IUPAC Name:
- 2,3-dihydroxypropyl laurate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: white, waxy substance
- Analytical purity: 90-95 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Paderborn, Germany
- Weight at study initiation: 410 g
- Housing: animals were housed individually
- Diet: Laborstandarddiät (Ssniff/Intermast), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 25%
Challenge: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 25%
Challenge: 25%
- No. of animals per dose:
- 5 (controls), 10 (in test groups)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (epicutaneous)
- Exposure period: 6 h (epicutaneous)
- Test groups: test substance in water
- Control group: water
- Site: left dorsum
- Frequency of applications: every 7 days
- Duration: Days 0-21
- Concentrations: epicutaneous 25%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 35
- Exposure period: 6 h
- Test groups: test substance in water
- Control group: test substance in water
- Site: right flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 h
OTHER:
Clinical examinations were performed during the study period. - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction 0%; challenge 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction 0%; challenge 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction 25%; challenge 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction 25%; challenge 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 25%; challenge: 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 25%; challenge: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- other: inconclusive
- Remarks:
- Criteria used for interpretation of results: EU
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