Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 211-746-3 | CAS number: 693-23-2
Endpoint summary
Administrative data
Description of key information
The test substance was not sensitizing in a guinea pig maximization test (OECD TG 406, 1981).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- 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)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A skin sensitization test according to OECD 406 has already excisted since 1989 and is sufficient for evaluation of the skin sensitisation potential of the test substance.
- 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 - Route:
- intradermal
- Vehicle:
- petrolatum
- Concentration / amount:
- 1st application: Induction 0.5 % intracutaneous
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 25 % occlusive epicutaneous - 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 - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- 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
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. 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.
- 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
- 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.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study dodecanedioic acid is not a skin sensitizer.
- 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 is not a skin sensitizer.
Reference
RESULTS OF PILOT STUDY: no skin irritation at 50 %
RESULTS OF TEST
- Sensitization reaction:
0/20 animals positive at 24 and 48 hours = no sensitization
no animals positive in control group
- 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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a guinea pig maximisation test according to Magnusson-Kligman there was no indication for a skin sensitising potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There was no indication for a sensitising potential in a maximisation test according to Magnusson and Kligman.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
