Registration Dossier
Registration Dossier
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EC number: 276-431-5 | CAS number: 72162-23-3 The high-boiling fraction separated by distillation from the products obtained from the reaction of nitric acid with cyclododecanol and cyclododecanone. Composed primarily of dodecanedioic acid, undecanedioic acid, and sebacic acid.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1989-02-14 to 1989-03-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions: No positive control (not required by 1981 version of Test Guideline)
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)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Dodecanedioic acid
- EC Number:
- 211-746-3
- EC Name:
- Dodecanedioic acid
- Cas Number:
- 693-23-2
- Molecular formula:
- C12H22O4
- IUPAC Name:
- dodecanedioic acid
- Details on test material:
- Dodecanedioic acid of Hüls AG.
Purity ca. 99 %;
main impurities: Homologous dicarboxylic acids
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
- Source: Fa Winkelmann, 4799 Borchem, Germany
- Age at study initiation:
- Weight at study initiation:324 g (mean test); 322 g (mean control)
- Housing: 1-5 animals per cage
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr):15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14.2.1989 To: 10.03.1989
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- petrolatum
- Concentration / amount:
- 1st application: Induction 0.5 % intracutaneous
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1st application: Induction 0.5 % intracutaneous
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous
- No. of animals per dose:
- 20
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Induction schedule:
day 0 injection,
day 6 induction of slight inflammation (10 % sodium lauryl sulfate in petrolatum)
days 7-9 patch treatment (48 hours)
- Injection details: 0.1 ml each at 6 positions on shoulders:
2 x Freund's Complete Adjuvant / deionized water (50:50)
2 x test substance 0.5 % in corn oil
2 x test substance 0.5 % in Freund's Complete Adjuvant / corn oil (50:50)
simultaneous and symmetrical application of each solution
controls: corn oil instead of test substance
- Challenge schedule: 2 weeks after end of induction, patch treatment for 24 hours
- Concentrations used for challenge:
25 % in vehicle with filter paper on left side; petrolatum on opposite side readings 24 and 48 hours after removal of patch
- Rechallenge: no
- Positive control: no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- first application: Induction 0.5 % intracutaneous; 2nd application: Induction 50 % occlusive epicutaneous; 3rd application: Challenge 25 % occlusive epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- See other information results section for details
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: first application: Induction 0.5 % intracutaneous; 2nd application: Induction 50 % occlusive epicutaneous; 3rd application: Challenge 25 % occlusive epicutaneous. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: See other information results section for details.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1st application: Induction 0.5 % intracutaneous; 2nd application: Induction 50 % occlusive epicutaneous; 3rd application: Challenge 25 % occlusive epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- See other information results section for details
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1st application: Induction 0.5 % intracutaneous; 2nd application: Induction 50 % occlusive epicutaneous; 3rd application: Challenge 25 % occlusive epicutaneous. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: See other information results section for details.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- See other information results section for details
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: See other information results section for details.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- See other information results section for details
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: See other information results section for details.
Any other information on results incl. tables
RESULTS OF PILOT STUDY: no skin irritation at 50 %
RESULTS OF TEST
- Sensitisation reaction:
- Clinical signs:
1st induction, FCA application sites: severe erythema and edema, necroses
1st induction, test substance + vehicle application sites: slight erythema and edema
1st induction, vehicle application sites: slight erythema
2nd induction, test and control group: severe erythema of the whole shoulder region; inflammation of the FCA injection sites,
in part with pus discharge and/or bleeding from scratching; eschar formation within 24 hours
- Other: Mean body weight gain 121 g in test group, 122 g in control group = expected range
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study dodecanedioic acid is not a skin sensitiser.
- Executive summary:
In the Guinea pig maximization test performed within this study, after intradermal and epicutaneous inductions with the test substance dodecanedioic acid none of the 20 guinea pigs showed positive response 24 hours (48 hours) after epicutaneous challenge. Under the conditions of the study dodecanedioic acid does not cause skin sensitisation.
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