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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 406-200-8 | CAS number: 117827-06-2 COUPLER II; UC-136
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the Test Guidelines described in the EEC Directive 84/449/EEC.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
- EC Number:
- 406-200-8
- EC Name:
- 3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
- Cas Number:
- 117827-06-2
- Molecular formula:
- C24H39Cl2NO2
- IUPAC Name:
- N-(3,5-dichloro-4-ethyl-2-hydroxyphenyl)hexadecanamide
- Details on test material:
- Identification : UC—136
Description : White powder
Batch number : Unknown
Purity : 98.5%
Instructions for test article storage : At room temperature in the dark in a tightly sealed container
Stability of test : substance Stable for one year maximal under storage conditions
Stability of test article in vehicle : Unknown
Safety precautions : Gloves, goggles and face mask were sufficient to ensure personnel health and safety.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Original Source : Charles River Wiga, Sulzfeld, West—Germany.
Total number of animals : 3 females
Age at start of treatment : Approx. 14 weeks
Body weight at start of treatment : 2533 — 2936 gram
Identification : Ear tag.
Acclimatisatjon : At least five days under test conditions.
HUSBANDRY
Room No.: 9
Conditions : Standard Laboratory Conditions. Air—conditioned with 7.5—15 air changes per
hour and hourly monitored environment with temperature 21 ± 3°C and relative ~ humidity 30—88%,
12 hours artificial fluorescent light / 12 hours dark.
Accommodation : Individually in cages with perforated floors equipped with an automatic
drinking system (ITL, Bergen / The Netherlands).
Diet : Standard laboratory rabbit diet (LKK—20, pellet diameter 4mm, Hope Farms,
Woerden I The Netherlands) approx. 100 gram per day. Certificates of analysis
are retained in the RCC NOTOX archives.
Water : Free access to tap—water diluted with decalcified water. Certificates of
analysis of tap—water are retained in the RCC NOTOX archives. - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 72 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 60 minutes
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritant / corrosive response data:
- No skin irritation was observed.
No corrosive effect was evident on the skin. - Other effects:
- In the area of application no staining of the treated skin by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- UC—136 resulted in a primary irritation index of 0 (non—irritating) when
applied to the intact rabbit skin.
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.
