Registration Dossier
Registration Dossier
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EC number: 278-355-8 | CAS number: 75980-60-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
- EC Number:
- 278-355-8
- EC Name:
- Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
- Cas Number:
- 75980-60-8
- Molecular formula:
- C22H21O2P
- IUPAC Name:
- (mesitylcarbonyl)(diphenyl)phosphine oxide
- Details on test material:
- - Name of test material (as cited in study report): Lucirin LR 8728 [Chemical name: diphenyl (2,4,6-trimethylbenzoyl) phosphineoxide]
- Analytical purity: not reported
- Physical state: pale yellow-coloured powder
- Lot/batch No.: 010213
- Storage condition of test material: stored in brown glass screw-top jars at approximately 4°C in the refrigerator
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CFY strain rats supplied by Bantin & Kingman Ltd, Grimston, Aldborough, Hull, UK
- Age at study initiation: approximately five to eight weeks old
- Weight at study initiation: mean weights: males weighed 126 - 150g, and the females 120 - 142g,
- Fasting period before study: overnight immediately before dosing and for approximately two hours after dosing
- Housing: 5 by sex in solid-floor polypropylene cages with sawdust bedding; the animals were given a unique number within the study by ear punching and a number written on a cage card
- Diet: Rat and Mouse Expanded Diet No 1, Special Diet Services Ltd, Witham, Essex, UK; ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 46 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50, 100, 300 and 500 mg/ml
- Amount of vehicle (if gavage): 10 ml
- Justification for choice of vehicle: test substance administered as suspension - Doses:
- 5000 mg/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 and weighing: animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation
- Necropsy of survivors performed: yes, all animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained.
- Other examinations performed: individual body weights were recorded on the day of treatment (day 0) and on days 7 and 14
Results and discussion
- Preliminary study:
- Because no deaths occurred in the range-finding study, LD50 of the test substance was considered to be greater than 5000 mg/kg bw and the highest dose level was therefore used for the main study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: no mortality occured
- Mortality:
- no mortality
- Clinical signs:
- other: - Hunched posture, lethargy and piloerection were noted in all animals one and four hours after dosing. - Decreased respiratory rate was also noted in all animals one hour after dosing. - All animals appeared normal one day after treatment.
- Gross pathology:
- no abnormalities were noted at necropsy of animals (killed at the end of the study).
Any other information on results incl. tables
Mean body weights (g):
Males:
| Time | 5000 mg/kg bw group |
| Day 0 | 137.6±9.6 |
| Day 7 | 170.8±11.6 |
| Day 14 | 216.2±12.5 |
Females:
| Time | 5000 mg/kg bw group |
| Day 0 | 128.8±8.4 |
| Day 7 | 152.6±7.7 |
| Day 14 | 180.6±12.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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