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Registration Dossier
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EC number: 948-383-1 | CAS number: -
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 Oct 1996 - 21 Jan 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Magnussen and Kligmann Method
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Valid study report available before REACh came into force, therefore no new LLNA test was performed.
Test material
- Reference substance name:
- Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate
- EC Number:
- 234-392-1
- EC Name:
- Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate
- Cas Number:
- 11138-60-6
- IUPAC Name:
- 2,2-bis[(octanoyloxy)methyl]butyl decanoate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: Liquid, yellow
- Analytical purity: 100%
- Lot/batch No.: C96043.01-5
- Expiration date of the lot/batch: 01.01.2006
- Storage condition of test material: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HRP inc. and Charles River Laboratories, USA
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 391- 489 g (males); 366 - 480 g (females)
- Housing: individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet: Agway Prolab Purina Guinea Pig Diet; ad libitum
- Water: ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature and humidity was controlled daily
- Photoperiod (hrs dark / hrs light): 12 / 12 h
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: intradermal injection 5%, epicutaneous application 100%
Challenge: 100%
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: intradermal injection 5%, epicutaneous application 100%
Challenge: 100%
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: Yes (intradermal: October 1st 1996 - October 3rd 1996; topical: October 1st 1996 - October 4th 1996)
2 animals were pre-treated with 2 intradermal injections of FCA/water emulsion (1:1) approx. 1 week prior to test material administration.
0.1 mL of the test substance (5% w/v) solved in propylene glycol was injected on either side of the spinal column and animals were observed for dermal irritation 24 h and 48 h after injection.
For the topical range-finding study, animals (3 per sex) were dosed with 0.1 mL test substance at 4 different concentrations (25%, 50%, 75% and 100% in ethyl alcohol) at different sites, 2 on either side of the column. Substance application occurred for over 24 h under occlusive conditions. Skin reactions were observed 24 and 48 h thereafter.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 1
- Control group: 2 (positive and irritation control)
- Site: A row of three injections was made on each side in the shoulder region.
- Frequency of applications: Days 1 and 8
- Duration: 25 days
- Concentrations: intradermal induction: 5%, topical induction: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 d after last induction application
- Exposure period: 24 h
- Test groups: 1
- Control group: 2 (positive and irritation control)
- Site: Flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches - Positive control substance(s):
- yes
- Remarks:
- Hexylcinnamic aldehyde (HCA)
Results and discussion
- Positive control results:
- Treatment with 50% HCA resulted in 30% positive response.
Treatment with 100% HCA resulted in 20% positive response (not sensitising, by definition). This lower effect might be due to decreased dermal absorption at high substance concentration.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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