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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 619-490-8 | CAS number: 303186-36-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 16, 2008 - November 3, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-{4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluorophenyl}-3-fluoro-4'-propyl-1,1'-biphenyl
- EC Number:
- 619-490-8
- Cas Number:
- 303186-36-9
- Molecular formula:
- C27H22F8O2
- IUPAC Name:
- 4-{4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluorophenyl}-3-fluoro-4'-propyl-1,1'-biphenyl
- Test material form:
- solid: bulk
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Before application, the test material was mixed with liquid paraffin and ground in a mortar using a pestle.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Age at study initiation:8 to 11 weeks
- Weight at study initiation: 245 g (range from 213 to 279 g)
- Fasting period before study: no
- Housing: separately in type III Makrolon cages with a shelter, placed on mobile racks
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24°C
- Humidity (%): 50 – 75%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 h
IN-LIFE DATES: From: day 1 To: day 15
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- paraffin oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: no data
- Type of wrap if used: self-adhesive fabric (Fixomull stretch, Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: yes
VEHICLE
Name: Liquid paraffin
Manufacturer:Merck KGaA, Darmstadt
Batch: K36930874711
Released until:December 31, 2011 - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 (m) / 5 (f)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Standard statistical methods have been applied for data processing.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All rats survived the observation period.
- Clinical signs:
- No signs of toxicity were observed in the 5 male and 5 female rats after dermal treatment with 2000 mg/kg of the test item.
- Body weight:
- The body weight development was slightly decreased on day 2 of the experimental part. This finding is considered to be not treatment related, but due to the limited motility of the rats induced by the tape.
- Gross pathology:
- The gross pathological examination revealed no organ alterations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- LD50 > 2000 mg/kg
- Conclusions:
- Based on the result of this study, the test item is be considered to have no acute toxic potential and the expected LD50 value is higher than 2000 mg/kg after dermal administration to rats.
- Executive summary:
This study was performed according to OECD 402 under GLP conditions. Based on the result of this study, the test item is be considered to have no acute toxic potential and the expected LD50 value is higher than 2000 mg/kg after dermal administration to rats.
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.
