Registration Dossier
Registration Dossier
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EC number: 605-460-1 | CAS number: 167004-78-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- Phosphinic acid, P-[3-(acetyloxy)-3-cyanopropyl]-P-methyl-, butyl ester
- EC Number:
- 605-460-1
- Cas Number:
- 167004-78-6
- Molecular formula:
- C11 H20 N O4 P
- IUPAC Name:
- Phosphinic acid, P-[3-(acetyloxy)-3-cyanopropyl]-P-methyl-, butyl ester
- Details on test material:
- Molecular weight: 261 g/mol
Molecular formular: C11H2ONO4P
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: supplied by the sponsor, Test substance: HOE 125869, batch number: CR 21422/01/940801
- Purity, including information on contaminants, isomers, etc.: 88.4% (w/w)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: -10°C (+-5°C)
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: The stability and absorption of the test material were not determined in this study.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd., Manston Road, Margate, Kent, UK
- Age at study initiation: 7 weeks
- Weight at study initiation: males: 264 g (average); females: 231 g (average)
- Housing: Rats were housed in groups of five according to sex in polycarbonate cages, except during the exposure period when they were housed singly.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19 °C and 23°C
- Humidity (%): between 45 and 65%
- Photoperiod (hrs dark / hrs light): 12 hours per day
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- After 24 hours, the plaster and gauze were removed and the treated skin washed with soap and water, to remove residual test material, then rinsed and dried.
- Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- male: 5 animals; female: 5 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made frequently after dosing on the day of treatment and at least once each morning thereafter. They were also observed in the afternoon on Mondays to Fridays except on Company and public holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: There were no signs of systemic reaction to treatment. The site of application of test material showed no irritation or other dermal changes.
- Gross pathology:
- There were no macroscopic abnormalities detected at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 value of the test substance in both male and female rats was greater than 5000 mg/kg body weight.
It was concluded that the test substance was of very low acute dermal toxicity to the rat. No classification according to CLP (EG) No. 1272/2008. - Executive summary:
In an acute dermal toxicity study according to EU Method B.3, 5 male and 5 female Sprague-Dawley rats were treated with a dose of 5000 mg/kg bw of the test item under semiocclusive conditions.
No mortality, clinical signs, signs of irritation, effects on body weight or macroscopic abnormalities were observed.
The LD50 was determined to be greater than 5000 mg/kg bw.
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