Registration Dossier
Registration Dossier
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: 219-847-4 | CAS number: 2550-26-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1980-02-26 to 1980-05-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP, similar to OECD TG 402
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-phenylbutan-2-one
- EC Number:
- 219-847-4
- EC Name:
- 4-phenylbutan-2-one
- Cas Number:
- 2550-26-7
- Molecular formula:
- C10H12O
- IUPAC Name:
- 4-phenylbutan-2-one
- Details on test material:
- - Name of test material (as cited in study report): Benzyl acetone
- Physical state: clear liquid, specific gravity = 0.98
- Impurities (identity and concentrations): not reported
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Nicholas Helf
- Age at study initiation: 9 weeks
- Weight at study initiation: 2.3 -2.8 kg
- Fasting period before study: no
- Housing: 2/cage in suspended wire mesh cages
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 200 square cm
- % coverage: approximately 10 % of the body surface
- Type of wrap if used: impervious material
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the exposure site was wiped, but not washed
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.0 g/kg bw - Duration of exposure:
- 24 h
- Doses:
- 5.0 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs - Statistics:
- Not reported
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died during the observation period of 14 days.
- Clinical signs:
- other: Isolated instances of diarrhea and mucousy diarrhea were noted during the study. Nine animals were normal on Day 14.
- Gross pathology:
- All animals, sacrificed on Day 14, were normal internally. One animal had scaly skin and one animal had ulcerated treated skin.
- Other findings:
- Skin reactions were variable ranging from slight to severe.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was acutely non toxic to rabbits in an acute dermal toxicity test with an LD50 value of >5000 mg/kg bw. The substance is not classified according to CLP.
- Executive summary:
Ten (5 male and 5 female) healthy, New Zealand White rabbits with initial body weights of 2.3-2.8 kilograms received one dermal application of test material. Food and water were available freely. The test material was applied to clipped, intact or abraded abdominal skin under occluded patches for 24 hours of contact. The exposure site was wiped, but not washed, to remove excess material. Observations for mortality and/or systemic effects were made daily for 14 days. Dermal reactions were scored at 24 hours by the Draize scoring system and were variable ranging from slight to severe. Body weights were recorded pretest and at 14 days. Body weight changes were within expected limits. Gross necropsy was conducted on all animals, where one animal had ulcerated treated skin and one animal had scaly treated skin. 5 g/kg no effects, acute dermal LD50 >5 g/kg.
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.
