Propanoic acid, 3-[[bis(2-methylpropoxy)phosphinothioyl]thio]-2-methyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

434-070-2

EC Name:

-

Cas Number:

268567-32-4

Molecular formula:

C12 H25 O4 P S2

IUPAC Name:

3-{[bis(2-methylpropoxy)(sulfanylidene)-λ⁵-phosphanyl]sulfanyl}-2-methylpropanoic acid

Test material form:

liquid: viscous

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (17 - 23°C) away from direct sunlight

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain as stated in the report: HanIbm: WIST (SPF)
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllingsdorf / Switzerland
- Age at study initiation: males 9 weeks, females 12 weeks
- Weight at study initiation: males 233 - 253 g, females 203 - 224 g
- Housing:During acclimatisation 5 in Makrolon type-4 cages, during treatment and observation individually in Makrolon type-3 cages
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433, rat maintenance diet , ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back of animals
- % coverage: 10 % of total body surface
- Type of wrap if used: semi-occlusive dressing fixed with an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Skin was flushed with lukewarm tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant concentration used: yes, 100 % of pure compound

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations for mortality and clinical symptoms: 4-times on first day, afterwards once daily
- Frequency of weighing: On first day, day 8 and day 15
- Necropsy of survivors performed: yes, all animals were sacrified and subjected to gross pathology

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:

other: None of the treated animals died. No clinical signs were observed.

Mortality:

No animal died.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No macroscopic findings were observed at necropsy.

Any other information on results incl. tables

 Body weight of male and female rats after single dermal treatment with 2000 mg/kg bw of test article

Body weight in grams:
Sex	Animal No.	Day of treatment	Day 8	Day 15
male	1	252.8	276.6	310.9
	2	246.8	260.8	284.6
	3	232.8	251.5	269.3
	4	253.4	270.9	298.4
	5	234.7	246.7	266.4
female	6	210.3	218.3	223.9
	7	202.7	203.1	212.3
	8	211.5	215.7	227.7
	9	223.7	223.5	234.7
	10	205.7	208.3	214.7

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met