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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 800-253-4 | CAS number: 1419212-73-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21-01-2015 to 04-02-2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study according to the guideline under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl heptadecanoate; 2-(4-heptadecanoylpiperazin-1-yl)ethyl heptadecanoate; 2-heptadecyl-1-[2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]-4,5-dihydro-1H-imidazole
- EC Number:
- 800-253-4
- Cas Number:
- 1419212-73-9
- IUPAC Name:
- 2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl heptadecanoate; 2-(4-heptadecanoylpiperazin-1-yl)ethyl heptadecanoate; 2-heptadecyl-1-[2-(2-hexadecyl-4,5-dihydro-1H-imidazol-1-yl)ethyl]-4,5-dihydro-1H-imidazole
- Reference substance name:
- Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction by-products
- IUPAC Name:
- Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction by-products
- Reference substance name:
- Reaction products of C16 saturated and C18 unsaturated fatty acids and fatty acid glycerides with by-products from 2 aminoethanol and ammonia reaction
- IUPAC Name:
- Reaction products of C16 saturated and C18 unsaturated fatty acids and fatty acid glycerides with by-products from 2 aminoethanol and ammonia reaction
- Test material form:
- liquid: viscous
- Details on test material:
- Identification: Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction products
Physical state / Appearance: brown extremely viscous liquid
Storage Conditions: room temperature in the dark
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Strain: Wistar (RccHan™:WIST)
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males: 234-250 g; females 206-220 g
- Housing: during 24 h exposure period individually, thereafter 5/sex/cage (suspended solid floor polypropylene cages furnished with woodflakes)
- Diet: 2014C Teklad Global Rodent diet ad libitum
- Water: ad libitum
- Acclimation period: ≥ 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): ≥ 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure ( % coverage) : 10%
- Type of wrap if used: surgical gauze semi-occluded with a piece of self-adhesive bandage
REMOVAL OF TEST SUBSTANCE: after 24 h exposure treated skin and surrounding hair was wiped with cotton wool moistened with arachis oil BP - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Body weight: at study start and weekly thereafter
- Clinical signs: 1/2, 1, 2, and 4 hours after exposure and then daily for 14 days
- Irritation: after removal of the dressing and daily for 14 days
- Mortality/morbidity: twice daily
- Necropsy : macroscopic examination - Statistics:
- NA
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- no effects
- Other findings:
- Signs of skin irritation in 3 males and all females (very slight to well-defined erythema, very slight oedema, crust formation, hemorrhage of dermal capillaries, small superficial scattered scabs and scab lifting to reveal glossy skin)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for dermal toxicity is > 2000 mg/kg bw
- Executive summary:
Wistar rats (5/sex) were dermally exposed to the substance for 24 hours (semi occlusion) at 2000 mg/kg bw. No mortality, clinical signs or macroscopic changes were seen. Body weight gain was within normal ranges. Most animals showed signs of irritation. The LD50 is > 2000 mg/kg bw
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.
