Registration Dossier
Registration Dossier
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EC number: 203-350-4 | CAS number: 105-99-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 May - 16 Jun 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. No positive control data were required at the time of the conduct of the study and are thus not stated in the study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- ( adopted 12 May 1981)
- Deviations:
- yes
- Remarks:
- the current guideline (adopted in 1992) requires positive control data
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study conducted before LLNA Guideline was established
Test material
- Reference substance name:
- Dibutyl adipate
- EC Number:
- 203-350-4
- EC Name:
- Dibutyl adipate
- Cas Number:
- 105-99-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- 1,6-dibutyl hexanedioate
- Details on test material:
- - Name of test material: Adipinsäure-di-n-butylester
- Physical state: clear liquid
- Analytical purity: approx. 99.7%
- Lot/batch No.: 774
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Animal strain as given in the report: Albino guinea pigs, Bor: DHPW
- Source: F. Winkelmann, Borchen, Germany
- Weight at study initiation: 348 g (test group), 352 g (control group)
- Housing: 1 – 5 animals in Makrolon cages, type IV
- Diet: G4 complete feed for guinea pigs, Ssniff Spezialfutter GmbH, Soest, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 – 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- maize oil
- Concentration / amount:
- Induction: 20% intradermal, 100% epicutaneous
Challenge: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- Induction: 20% intradermal, 100% epicutaneous
Challenge: 100%
- No. of animals per dose:
- 10 (control), 20 (in test group)
- Details on study design:
- RANGE FINDING TESTS:
Concentration levels have been selected based on a pretest which has shown that the test item unchanged (100%) did not result in skin irritation.
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 (Freund's complete adjuvant)/water
Injection 2: 20% (v/v) test substance in maize oil
Injection 3: 20% (v/v) test substance in a 1:1 mixture (v/v) FCA/water
Due to the non irritation seen during pretesting, 24 h prior to epicutaneous induction the skin was pretreated with 10% SDS in petrolatum.
Epicutaneous: 100% test substance
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: maize oil
Injection 3: maize oil in a 1:1 mixture (v/v) FCA/water
Epicutaneous: maize oil
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0 and 8
- Concentrations: intradermal 20%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: left flank
- Concentrations: 100%
- Evaluation (hr after challenge): 48 and 72 h - Challenge controls:
- The control group is actually a challenge control.
- 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%; epicutaneous: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; epicutaneous: 100% . No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 20%; epicutaneous: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 20%; epicutaneous: 100% . No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; epicutaneous: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; epicutaneous: 100% . No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 20%; epicutaneous: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 20%; epicutaneous: 100% . No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Local reactions during the induction phase
1. After intracutaneous application: In test and control animals, all injection areas treated with FCA exhibited strong erythema, edema and necrosis. The injection areas of the test and control animals treated with 20% test substance in maize oil and with maize oil alone (control) exhibited slight erythema and edema.
2. After epicutaneous application for 48 h: After the patches were removed from the test and control animals treated with FCA the area of application was inflamed with erythema and edema. 24 hours after the patches were removed eschar formation was evident at the injection site.
Clinical signs and body weight gain
No other clinical signs were noted. The body weight development was comparable in control and test animals.
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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