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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 451-900-9 | CAS number: 894406-76-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA 40 CFR
- GLP compliance:
- yes
Test material
- Test material form:
- other: solid gel
- Details on test material:
- - Name of test material: Didecyldimethylammonium carbonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation:
- Weight at study initiation:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 0.5 - 1 hour, 24 hours
- Number of animals:
- 1 animal
- Details on study design:
- TEST SITE
- Area of exposure: 1x1 inch
SCORING SYSTE
- Draize JH, 1959
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 0.5 - 1 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 0.5 - 1 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Irritant / corrosive response data:
- Severe irritation was observed in the animal 0.5 - 1 and 24 hours following application. Changes noted in the colouration and/or texture of the skin included dark and light brown, dark red and purple discolouration, blanching, coriaceousness and necrosis. Due to the evidence of corrosion (necrosis) exhibited in this single animal at the 24 hour reading, this study was terminated without testing in additional animals.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered corrosive in this skin irritation test.
- Executive summary:
A study was carried out according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and FIFRA 40 CFR. The study was conducted to assess the potential of a 50 % active ingredient formulation of the test material to cause irritation after one topical application to the skin of a New Zealand White male rabbit for four hours. Signs of skin reaction were observed 0.5 - 1 hour and 24 hours post application. Severe irritation was observed. Changes noted in the colouration and/or texture of the skin included dark and light brown, dark red and purple discolouration, blanching, coriaceousness and necrosis. Due to the evidence of corrosion (necrosis) exhibited in this single animal at the 24 hour reading, this study was terminated without testing in additional animals. The test item was considered to be corrosive in this skin irritation test.
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.
