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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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:
2004
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

Constituent 1
Chemical structure
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

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.