Tris[2-chloro-1-(chloromethyl)ethyl] phosphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study generated according to internationally accepted testing guidelines and according to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

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

Details on test material:

- Name of test material (as cited in study report): Tolgard TDCP MK1
- Physical state: colourless liquid
- Storage condition of test material: In the dark under ambient conditions
- Analytical purity: not stated

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) limited
- Age at study initiation: 6 - 8 weeks old
- Weight at study initiation: 197 - 278 g
- Fasting period before study: Not fasted
- Housing: Housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays with a maximum of 5 animals per cage.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days before test commencment


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): mean of 47
- 12 hour light / dark cycle

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Animals observed for 14 days.
TEST SITE
- Area of exposure: The animals dorsal surface
- % coverage: up to at least 10%
- Type of wrap if used: gauze dressing, encircled with a strip of non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was wiped with a water dampened tissue
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24h

Doses:

Dose-range finding study: 400, 1000, 1500, 2000 mg/kg bw
Main Study: 2000mg/kg bw

No. of animals per sex per dose:

Dose-range finding study: 2 males and 2 females per dose group
Main study: 5 males and 5 females per dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Prior to dosing, 7 days after dosing and at the end of day 14.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

In the dose range finding study there were no deaths and no clinical signs or gross post mortem observations.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortalities observed.

Clinical signs:

other: No Clinical signs observed.

Gross pathology:

No abnormalities were detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Low acute toxicity

Conclusions:

LD50 > 2000mg/kg bw in Sprague-Dawley rats under given experimental conditions.