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Registration Dossier
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EC number: 305-758-9 | CAS number: 95009-31-7
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:
- 1 Feb - 22 Apr 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions; no data on positive controls, challenge on both flanks
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- no data on positive controls, challenge on both flanks
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A valid study report was available before REACh came into force, therefore no additional LLNA test was performed.
Test material
- Reference substance name:
- Fatty acids, C14-18 and C16-18 unsatd., triesters with trimethylolpropane
- EC Number:
- 268-093-2
- EC Name:
- Fatty acids, C14-18 and C16-18 unsatd., triesters with trimethylolpropane
- Molecular formula:
- Not applicable, substance is a UVCB.
- IUPAC Name:
- Fatty acids, C16-18 (even numbered) and C16-18 unsatd. (even numbered), triesters with trimethylolpropane
- Details on test material:
- - Name of test material (as cited in study report): Only trade name given
- Substance type: Fatty acids, C16-18 and C18 unsatured, triesters with trimethylol propane
- Physical state: Liquid, yellow
- Analytical purity: 100%
- Lot/batch No.: 3381
- Expiration date of the lot/batch: July, 1995
- Storage condition of test material: Room temperature, dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white; Hsd/Win:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: approx. 345 g (main study)
- Housing: Groups of 2-3 animals in Makrolon Type IV cages
- Diet: Pelleted Altromin Maintenance Diet 3022, Batch No. 020494/1337 and 020794/1616; Altromin GmbH, Lage, Germany, ad libitum; carrots were optionally added
- Water: tap-water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 45-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12 / 12 (Music during light hours)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 100% for both, induction and challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 100% for both, induction and challenge
- No. of animals per dose:
- 20 animals in treatment group and 10 animals in control group
- Details on study design:
- RANGE FINDING TESTS: Yes
Evaluation of dermal effects was done by treating 3 animals with vehicle, 12.5%, 25%, 50% or 100% of the test substance and observation of irritating effects 24 h and 48 h after treatment. Since no skin reaction was seen at all tested concentrations up to 100%, the test substance was used as 100% for induction and further for challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 1 (20 animals)
- Control group: 1 (10 animals)
- Site: left cranial sheared flank
- Frequency of applications: once a week
- Duration: 3 weeks, application once a week
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction
- Exposure period: 6 h
- Test groups: 1 (20 animals received 100% of test substance))
- Control group: 1 (10 animals received 100% of test substance)
- Site: both shared flanks (caudal)
- Concentrations: 100%
- Evaluation (hr after challenge): 24 h, 48 h, 72 h - 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:
- 1
- Total no. in group:
- 20
- Clinical observations:
- 1 animal showed slight reaction, both on the left (induced) and right (non-induced) side
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: 1 animal showed slight reaction, both on the left (induced) and right (non-induced) side.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight dermal effects on the right flank and left flank in 1 animal
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight dermal effects on the right flank and left flank in 1 animal.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- 5 animals showed slight reaction, both on the left (induced) flank
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: 5 animals showed slight reaction, both on the left (induced) flank.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight dermal effects on the right flank in 1 animal
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight dermal effects on the right flank in 1 animal.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- 1 animal showed slight reaction, both on the left (induced) and right (non-induced) side
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: 1 animal showed slight reaction, both on the left (induced) and right (non-induced) side.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No effects.
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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