Reaction products of phosphoryl trichloride and 2-methyloxirane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed to Guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-chloropropan-2-yl bis(2-chloropropyl) phosphate; bis(1-chloropropan-2-yl) 2-chloropropyl phosphate; tris(1-chloropropan-2-yl) phosphate; tris(2-chloropropyl) phosphate

EC Number:

807-935-0

Cas Number:

1244733-77-4

Molecular formula:

C9H18Cl3O4P

IUPAC Name:

1-chloropropan-2-yl bis(2-chloropropyl) phosphate; bis(1-chloropropan-2-yl) 2-chloropropyl phosphate; tris(1-chloropropan-2-yl) phosphate; tris(2-chloropropyl) phosphate

Specific details on test material used for the study:

Received 30 Novemeber 1988
colourless liquid
stored in dark at ambient temperature
specific gravity 1.29

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
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 159-274g
- Fasting period before study: none
- Housing: polypropylene cages with mesh floors, max 5 animals per cage
- Diet (e.g. ad libitum): Expanded Rat& Mouse Maintenance Diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period:minimum 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22C
- Humidity (%): 48%
- Air changes (per hr): not given
- Photoperiod (hrs dark / hrs light ): 12 hr light/dark cycle


IN-LIFE DATES: From: 18 January 1989 To: 9 February 1989

Administration / exposure

Type of coverage:

other: Sleek non-irritating Tape, Smith& Nephew

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage: upto at least 10%
- Type of wrap if used: Sleek Tape, Smith & Nephew


REMOVAL OF TEST SUBSTANCE
- Washing (if done): water dampened tissue
- Time after start of exposure:24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 400, 1000, 1500, 2000 mg/kg
- Concentration (if solution):
- Constant volume or concentration used: no
- For solids, paste formed: yes/no


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of exposure:

24 hrs

Doses:

Rangefinding study 400, 1000, 1500, 2000 mg/kg
main study 2000 mg/kg

No. of animals per sex per dose:

2 per sex per dose rangefinding
5 per sex per dose main study

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:daily after exposure, animals weighed prior to dosing, day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels

Key result

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

nil

Clinical signs:

other: other: no clinical signs noted

Gross pathology:

nop abnormalities detected.

Any other information on results incl. tables

The median dermal lethal dose (LD50) of Tolgard TMCP in rats is greater than 2000 mg/kg

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median dermal lethal dose (LD50) of Tolgard TMCP in rats is greater than 2000 mg/kg

Executive summary:

The acute dermal toxicity of Tolgard TMCP was investigated in rats.

A dose rangeing study in pairs of rats indicated that the LD50 value by the dermal route is greater than 2000 mg/kg bw. A main study dose level of 2000 mg/kg bw was selected accordingly.

In the main study, no deaths occured and no clinical signs were noted after 24h dermal administration, under occlusion, of Tolgard TMCP, at a dose level of 2000 mg/kg bw.

The medium Dermal Lethal Dose (LD50) of Tolgard TMCP in rats in this study is greater than 2000 mg/kg bw.