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EC number: 628-817-3 | CAS number: 990-91-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From July 2004 to 2004-09-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No certificate of analysis in the study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2003-02-13
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- dibenzyl {[bis(benzyloxy)phosphoryl]oxy}phosphonate
- EC Number:
- 628-817-3
- Cas Number:
- 990-91-0
- Molecular formula:
- C28H28O7P2
- IUPAC Name:
- dibenzyl {[bis(benzyloxy)phosphoryl]oxy}phosphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- CAS 990-91-0
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: Charles River (UK) Ltd, Margate, Kent, UK
- Females nulliparous and non-pregnant
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: At least 200 g (The weight variation did not exceed :!: 20% of the mean weight for each sex)
- Housing: suspended solid-tloor polypropylene cages fumished with woodflakes. The animais were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet (e.g. ad libitum) & Water (e.g. ad libitum): Free access to mains drinking water and food (Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK) was allowed throughout the study.
- Acclimation period: acclimatisation period of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): ifleen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous Light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES: From 16 August 2004 to 30 August 2004
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed ovcr the treatment area and senù-occluded with a piece of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin and surrounding hair wiped wi1h cotton wool mois1ened with distilled water to remove any residual test material.
- Time after start of exposure: 24-hour
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
VEHICLE
- Amount(s) applied (volume or weight with unit): the test material was moistened with distilled water - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- 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: 30 minutes, 1h, 2h and 4 hours after dosing and subsequently once daily for fourteen days.
- weighing:Days 0, 7 and 14
- Necropsy of survivors performed: yes
- Dermal reactions: primary irritation and scored according to scale from Draize J H (1977) "Dermal and Eye Toxicity Tests" ln: Principles and Procedures for Evaluating the Toxicity ofHousebold Substances, National Academy of Sciences, Washington DC p.31
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortaliy observed
- Clinical signs:
- other: no clinicals signs observed
- Gross pathology:
- No abnomalities were noted at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
Assessment of acute dermal toxicity with Tetrabenzyl pyrophosphate in the rat was realised according to the OECD 402 guideline and under GLP conditions.
Tetrabenzyl pyrophosphate was administered to 5 males and 5 females Sprague Dawley rats at 2000 mg/kg body weight.
Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice.
At 2000 mg/kg, no mortality occurred and no signs of dermal irritation were observed.
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