DS-2920A-E

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 - 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:

adopted 24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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): DS-2920A-E
- Physical state: orange solid
- Analytical purity: no data
- Lot/batch No.: 004
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

other: Sprague-Dawley (Crl : CD ® (SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd ., Margate, Kent, UK
- Age at study initiation: eight to twelve weeks.
- Weight at study initiation: males: 205 - 218 g, females: 200 - 221 g,
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: The animals were housed in suspended polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet: Rat and Mouse Expanded Diet No . 1, Special Diet Services Limited, Witham, Essex, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 51 - 65
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: The test material was moistened with distilled water.

Details on dermal exposure:

TEST SITE
- On the day before treatment the back and flanks of each animal were clipped free of hair using veterinary dippers.
- Area of exposure: back and flanks
- % coverage: approximating to 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semioccluded with a piece of self-adhesive bandage. The animals were caged individually for the 24-hour exposure period. Shortly after dosing the dressings were examined to ensure that they were securely in place.

REMOVAL OF TEST SUBSTANCE
- Washing: the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with
distilled water to remove any residual test material.
- Time after start of exposure: 24h

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

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: once daily
- Frequency of weighing: prior to application of the test material on day 0 and on day 7 and 14.
- Necropsy of survivors performed: yes, animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
- Other examinations performed: clinical signs, body weight, test sites were examined for evidence of primary irritation and scored according to Draize J.H. (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy 01 Sciences, Washington DC p. 31.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality. No signs of systemic toxicity.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the study. Orange-coloured staining caused by the test material was noted at the treated skin sites of all animals and prevented an evaluation of the degree of erythema on Day 1. No signs of skin irritation

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Signs of toxicity (local):
On day 1, scoring for erythema due to orange staining was not possible. No signs of dermal irritation were detected until the end of the study.

Any other information on results incl. tables

Table 1: Mean body weight
		Mean	SD*
Day 0	Males	213.4	5.22
	Females	208.6	8.62
Day 7	Males	256.6	18.37
	Females	221.6	9.29
Day 14	Males	311.4	23.16
	Females	238	11.98

Table 2: Body weight gain (g) during week 1 and 2
		Mean	SD*
Week 1	Males	43.2	15.91
	Females	13.0	3.61
Week 2	Males	54.8	14.81
	Females	16.4	3.51

* standard deviation