Registration Dossier
Registration Dossier
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EC number: 295-118-4 | CAS number: 91844-53-0
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 Jul - 4 Aug 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- relative humidity was higher than 70% on several days of the study, this did not effect the study outcome.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Niedersächsisches Landesamt für Ökologie, Hildesheim, Germany
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Sorbitan, octanoate (2:3)
- EC Number:
- 295-118-4
- EC Name:
- Sorbitan, octanoate (2:3)
- Cas Number:
- 91844-53-0
- Molecular formula:
- Not available for UVCB
- IUPAC Name:
- Sorbitan, octanoate (2:3)
- Details on test material:
- - Name of test material (as cited in study report): Only trade name given
- Substance type: organic
- Physical state: amber liquid
- Analytical purity: no data
- Lot/batch No.: ES665M0001
- Expiration date of the lot/batch: June 2007
- Storage condition of test material: room temperature (20 ± 2 °C)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc.DH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: males: 396 - 444 g; females: 376 - 408 g
- Housing: group-housed for up to a maximum of 5 animals per cage in a battery of cages, equipped with a paper disposal system
- Diet: "Teklad Global Guinea Pig Diet" (pelleted diet) produced by Harlan Teklad, Blackthorn Bicester, Oxon, England (Batch No. N113), ad libitum.
- Water: Tap water as for human consumption was continuously available, ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C - 23 °C
- Humidity (%): 50% - 83%
- Air changes (per hr): 16 per h
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- peanut oil
- Concentration / amount:
- Induction: intradermal 5%, epidermal 100%
Challenge: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- Induction: intradermal 5%, epidermal 100%
Challenge: 100%
- No. of animals per dose:
- 5 (controls), 10 (in test group)
- Details on study design:
- RANGE FINDING TESTS:
For the intradermal injection, the test article was diluted with aqua ad injectabilia and Freund's complete adjuvant (FCA; batch No. 054K8931, SIGMA, Steinheim) to a final concentration of 5.0%. Two animals were treated, skin reactions were recorded 48 h and 72 h after treatment. For the dermal application, the liquid article was used undiluted. A closed patch exposure was effected by means of an occlusive bandage using cellulose swabs (Pur-Zellin®, Hartmann AG, Heidenheim/Brenz), Leukosilk® (Beiersdorf AG, Hamburg) and non-irritating tape Elastoplast® (Beiersdorf AG, Hamburg), which enveloped the whole animal's trunk. Two animals were employed and skin reactions were recorded 48 and 72 h post application.
According to the results obtained in the preliminary test, the concentrations of the test article used in the main test were 100% (undiluted) for dermal application and 5% for intradermal injection.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: test substance in vehicle (peanut oil)
Injection 3: test substance in a 1:1 mixture (v/v) FCA/peanut oil
Epicutaneous: seven days after intradermal induction the previous injection sites were covered occlusively for 48 h with a patch carrying the test article (100%)
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: vehicle (peanut oil)
Injection 3: vehicle (peanut oil) in FCA
Epicutaneous: seven days after intradermal induction the previous injection sites were covered occlusively for 48 h with a patch carrying the vehicle
- Site: either side of spine (intradermal + epicutaneous)
- Frequency of applications and duration:
intradermal induction: single application at test start
epidermal induction: seven days after intradermal induction, for 48 hours
- Concentrations: three pairs of intradermal injections 5%, epidermal 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after end of epidermal induction
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: right flank (vehicle) and left flank (test substance)
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h - Challenge controls:
- The control group is actually a challenge control
- Positive control substance(s):
- yes
- Remarks:
- 4-aminobenzoic acid ethyl ester (benzocaine, CAS: 94-09-7, Batch 044K0697) in vaseline
Results and discussion
- Positive control results:
- The positive control substance (50% 4-aminobenzoic acid in vaseline) induced positive reactions in 5/10 animals (50%), thus meeting
the reliability criteria for the GPMT test (≥ 30% positive response).
In vivo (non-LLNA)
Resultsopen allclose all
- 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:
- 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.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- 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: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- 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: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 50 %. No with. + reactions: 5.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 50 %. No with. + reactions: 5.0. 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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