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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-756-1 | CAS number: 110-31-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Occlusive dressing according to former guideline, prolonged exposure time (24 h), test substance was not removed after exposure.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Occlusive dressing according to former guideline, prolonged exposure time (24 h), test substance was not removed after exposure.
- GLP compliance:
- no
Test material
- Reference substance name:
- Amides, C16-C18 (even) , N,N'-ethylenebis
- EC Number:
- 931-299-4
- Cas Number:
- 68390-94-3
- Molecular formula:
- not available UVCB
- IUPAC Name:
- Amides, C16-C18 (even) , N,N'-ethylenebis
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Hoechst-Wachs C Mikropulver (Bis-stearoyl/palmitoyl-ethylendiamid)
- Molecular formula: C38H76N2O2
- Molecular weight: 593
- Physical state: yellowish-white powder
- Analytical purity: technical
- Impurities (identity and concentrations): non-reacted stearic acid, concentration not specified; ethylene diamine in ppm-range
- Composition of test material, percentage of components: 60% Bis-stearoyl-ethylene diamide, 40% Bis-palmitoyl ethylene diamide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: own breeding
- Weight at study initiation: 2.16-2.45 kg
- Housing: separated in single cages
- Diet: standard diet ERKA 8300 (Robert Koch oHG, Hamm), ad libitum
- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: one half shaved and the other additionally abraded
- Vehicle:
- other: polyethylene glycol 400
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, moistened with 1.2 mL polyethylene glycol 400
VEHICLE
- Amount(s) applied (volume or weight with unit): 1.2 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
Reading time points: 24, 48 and 72 h - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm on the shaved flank
- Type of wrap if used: the moistened test material was applied to 2.5 x 2.5 cm cellulose pads from Hansamed, the pads were fixed to the prepared application site and covered with an indifferent, impermeable polyethylene film (6-8 cm width). Subsequently, the whole trunk of the animals was wrapped with an elastic polyurethan warp bandage (permanent bandage K, Lohmann) and left in place for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h in the 2 affected animals
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- No erythema was observed in abraded skin. Edema of grade 1 was observed in 4/6 animals in abraded skin after 24 hours which was fully reversible after 48 hours. After 24-h exposure to intact skin, animals #2 and #3 showed a mean edema score of 0.33 after 24, 48 and 72 h.
- Other effects:
- No further local and systemic effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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.
