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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 253-039-2 | CAS number: 36443-68-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Apr. 1, 1992 to Jun. 22, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
- EC Number:
- 253-039-2
- EC Name:
- Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
- Cas Number:
- 36443-68-2
- Molecular formula:
- C34H50O8
- IUPAC Name:
- ethane-1,2-diylbis(oxyethane-2,1-diyl) bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propanoate]
- Details on test material:
- - Physical state: Solid, White
- Storage condition of test material: Room Temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited (Animal Production) 4332 stein, Switzerland
- Weight at study initiation: 202 to 229 g
- Housing: Individually housed, in Macrolon cages type 3, with standarized soft wood bedding
- Diet: ad libitum, NAFAG 890 TOX
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
IN-LIFE DATES: From May 21, 1992 to June 4, 1994.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: guaze-lined semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleaned with lukewarm water
- Time after start of exposure: 24 hour
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Constant volume or concentration used: yes (4 mL/kg body weight)
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5% carboxymethylcellulose in 0.1% aqueous polysorbate 80 - Duration of exposure:
- 24 hours
- Doses:
- 2,000 mg/kg body weight
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations and weighing on Day 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- None
Results and discussion
- Preliminary study:
- Limit Test
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: Piloerection was seen, that is a common unspecific clinical sign in acute dermal tests. The animals recovered within 2 to 3 days. At autopsy, no deviations from normal morphology were found.
- Gross pathology:
- None
- Other findings:
- Other Observations: No deviation from normal morphology were found upon necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Upon an acute dermal administration of 24 hours and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined for the test item:
LD50 in male rats: greater than 2000 mg/kg body weight
LD50 in female rats: greater than 2000 mg/kg body weight
LD50 in rats of both sexes: greater than 2000 mg/kg body weight
Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 to 3 days. At autopsy, no deviations from normal morphology were found.
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.
