2,4,6-tri-n-propyl-2,4,6-trioxo-1,3,5,2,4,6-trioxatriphosphorinane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-07-25 to 1995-08-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: PPA 4/94 from September 1994
- Expiration date of the lot/batch: June 1996
- Purity test date: 1995-03-06

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: darkness at room temperature in a fume cupboard
- Stability under test conditions: stable

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: 8-9 weeks
- Weight at study initiation: females: 194+/- 8 g, males: 223+/-6 g
- Housing: macrolon cages in fully air conditioned rooms
- Diet: ssniff' R/M-H (V1534) ad libitum
- Water: tap water ad libitum
- Acclimation period: none, breeding at same conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal skin, shaved and intact skin, about 30 cm2
- Type of wrap if used: aliminum foil and elastic plaster bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000 mg/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: symptoms were recorded twice daily, animals were weighed weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: none

Gross pathology:

no macroscopically visible changes

Other findings:

The treated skin area was partly brown-beige discoloured, red, dry, rough, sore, incrusted and scally.
Additionally open wound, pink coloured new skin and scales were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 value of the test item was determined to be > 2000 mg/kg bw.

Executive summary:

To assess the acute dermal toxicity of the test substance, a single (limit) dose of 2000 mg/kg bw was administered undiluted to the shaved and intact dorsal skin of 5 male and 5 female Wistar rats. The study was conducted according to OECD Guideline 402 (1987). After the 24 h exposure the occlusive wrap was removed and the test sites washed. During the 14 days observation period no clinical signs of toxicity and body weight changes were recorded. No deaths occurred during the study. The following local effects were recorded: The treated skin area was partly brown-beige discoloured, red, dry, rough, sore, incrusted and scally. Additionally open wound, pink coloured new skin and scales were observed. At necropsy, no macroscopical changes were found. Based on the available data, the LD50 value of the test item was determined to be > 2000 mg/kg bw.