Phosphoric acid, P,P'-[2,2-bis(chloromethyl)-1,3-propanediyl] P,P,P',P'-tetrakis(2-chloro-1-methylethyl) ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 January - 9 February 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)

EC Number:

253-760-2

EC Name:

2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)

Cas Number:

38051-10-4

Molecular formula:

C13H24Cl6O8P2

IUPAC Name:

2,2-bis(chloromethyl)propane-1,3-diyl tetrakis(2-chloroethyl) bis(phosphate)

Details on test material:

Product name: Tolgard V6
Appearance: colourless liquid

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 Ltd, UK
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 200 - 291g
- Housing: maximum 5 animals of same sex in polypropylene cages
- Diet: ad libitum (Expanded Rat and Mouse Maintenance Diet)
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Mean relative humidity (%): 48
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: at least 10% of body surface
- Type of wrap if used: non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24h

Duration of exposure:

24 hours

Doses:

- Range finding study: 400, 1000, 1500 and 2000 mg/kg
- Main study: 2000 mg/kg

No. of animals per sex per dose:

- Range finding study: 2 males and 2 females per dose level
- Main study: 5 male and 5 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently on day of dosing and 14 days following dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Preliminary study:

No deaths, no clinical signs and no gross post mortem observations noted

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No animals died during study period

Clinical signs:

other: No clinical signs noted

Gross pathology:

No abnormalities at post mortem examination noticed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median dermal lethal dose (LD50) of the test substance in rats is greater than 2000 mg/kg

Executive summary:

In an acute dermal toxicity study conducted according to OECD Guideline No.402, 5 male and 5 female Sprage-Dawley rats were treated with undiluted2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate) at a dose level of 2000 mg/kg for 24 h under occlusive conditions. After removal of the test substance by washing the animals were observed for 14 days. No deaths and clinical signs have been observed in any of the tested animals. At post mortem examination no abnormalities were detected and body weight gains during the course of the study were normal.

Dermal LD50 males > 2000 mg/kg bw

Dermal LD50 females > 2000 mg/kg bw