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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
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