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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 413-390-6 | CAS number: 149144-85-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September - October 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): COSMACOL EMI
- Substance type: pure active substance
- Physical state: liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: "Padre Antonio" Mariano Comense (CO), Italy
- Age at study initiation: no data
- Weight at study initiation: 200 - 300 g
- Housing: in groups of ten in transparent polycarbonate cages (dimensions: 590x385x200 mm)
- Diet (e.g. ad libitum): standard complete pellet diet ad libitum
- Water (e.g. ad libitum): filtered water from an automatic watering system
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1992-09-07 To: 1992-10-08
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Concentration of test material used at induction: 100% (unduluted) Concentration of test material used for challenge: 100% (undiluted)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Concentration of test material used at induction: 100% (unduluted) Concentration of test material used for challenge: 100% (undiluted)
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS: no data
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 0.5 mL test substance
- Control group: 0.5 mL distilled water
- Site: on the back
- Frequency of applications: on days 0, 7 and 14
- Duration: 3 weeks
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 28
- Exposure period: 6 h
- Test groups: 0.5 mL test substance and 0.5 mL distilled water
- Control group: 0.5 mL test substance and 0.5 mL distilled water
- Site: test material at the right flank, water at the left flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 and 72 h - Positive control substance(s):
- no
Results and discussion
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:
- 10
- 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: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- 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: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 100 %
Signs of irritation during induction:
NONE
Evidence of sensitisation of each challenge concentration:
0/20
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- During the study no signs of erythema and/or oedema were observed in treated and control animals. The test material bis(C12-C13)alkyl-2-hydroxybutandioate was considered to be not skin-sensitising in guinea pigs.
- Executive summary:
An allergic sensitisation test was carried out on test material bis(C12-C13)alkyl-2-hydroxybutandioate according to OECD Guideline 406.
20 guinea pigs were used in the test, 10 as control and 10 were treated with the test material. The test consisted of 2 phases, an induction phase and a challenge phase. During the induction phase the test mateial was applied on the skin at a dose of 0.5 mL/animal. The dressing was left in place for 6 hours. The same operation was repeated after 7 and 14 days. The 10 control animals received the same treatment but distilled water was used instead of the test material. 28 days after the beginning of treatment a challenge phase was carried out on both groups of animals. 0.5 mL of test material was applied on the left flank of each animal and 0.5 mL of water was applied to the right side. The dressing was left in place for 6 hours. 24, 48 and 72 hours after the challenge phase began, all animals were evaluated.
No signs of erythema or oedema were found. Therefore the test material bis(C12-C13)alkyl-2-hydroxybutandioate was considered as non-sensitising to the skin of guinea pigs.
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.
