Registration Dossier
Registration Dossier
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EC number: 267-022-2 | CAS number: 67762-53-2
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions (no analytical purity reported)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- analytical purity not reported
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Fatty acids, C5-9, tetraesters with pentaerythritol
- EC Number:
- 267-022-2
- EC Name:
- Fatty acids, C5-9, tetraesters with pentaerythritol
- Cas Number:
- 67762-53-2
- Molecular formula:
- Not applicable to a UVCB
- IUPAC Name:
- Fatty acids, C5-9, tetraesters with 2,2-Bis(hydroxymethyl)1,3-propanediol
- Details on test material:
- Name of test material (as cited in study report): only trade given
- Physical state: yellow liquid
- Analytical purity: not reported
- Lot/batch No.: CRU 98433
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino Guinea Pigs
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Convance Research Products Inc., Denver, Pennsylvania; USA
- Age at study initiation: approximately 4-7 weeks at dosing (range-finding study; intradermal); approximately 9-12 weeks (rang-finding study; topical); approximately 5-7 weeks at first dose (sensitisation study)
- Weight at study initiation: 376-428 g
- Housing: individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet: certified Guinea Pig Diet, No. 5026, ad libitum
- Water: automatic watering system (Municipal water supply), ad libitum
- Acclimation period: 8 days (range-finding animals); 14 days (sensitization animals)
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: 5% (intradermal), 100% (epicutaneous)
Challenge: 100% and 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: 5% (intradermal), 100% (epicutaneous)
Challenge: 100% and 50%
- No. of animals per dose:
- 5 (controls), 10 (in test groups)
- Details on study design:
- RANGE FINDING TESTS:
Intradermal:
Two animals were administered intradermal injections (2 injection / animal) of a 5% v/v concentration of test substance in propylene glycol, one on either side of the spinal column. The concentration tested did not produce extensive tissue damage or severe systemic toxicity.
Topical:
4 animals were tested at 4 different concentrations (25, 50, 75% v/v; 100%) per animal (one concentration/site), two on either side of the spinal column. 24 h and 48 h after removal of the patches no signs of erythema and edema were observed for at any of the concentration tested.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and
- Test group:
Intradermal (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FCA/ water
Injection 2: test substance in propylene glycol
Injection 3: test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: test substance in propylene glycol
- Control group:
Intradermal (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FCA/ water
Injection 2: propylene glycol
Injection 3: propylene glycol at 50% (v/v) in a 1:1 mixture (v/v) FCA/water
Epicutaneous: propylene glycol
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 1-8
- Concentrations: Intradermal 5%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: both flanks (two concentrations were applied for a total of two sites per animal)
- Concentrations: 100% and 50%
- Evaluation (hr after challenge): 24 and 48 h after patch removal
- Positive control substance(s):
- yes
- Remarks:
- hexylcinnamic aldehyde (HCA)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons).
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons)..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- 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: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- 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: test group. 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:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- 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: 50%. 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:
- 4
- Clinical observations:
- one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: one animal was sacrificed on Day 10 at the end of topical induction exposure, due to dosing trauma (humane reasons).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- 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: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
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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