Phosphorothioic triamide, N-propyl-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April - June 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

April 24, 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

(from the competent authority) Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht Rheinland-Pfalz

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide

EC Number:

700-457-2

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 8712 / 056
- Purity: 99.6 g / 100 g
pH-value: ca. 5 (undiluted test substance, moistened with water)

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The solid test substance was minimally moistened with a suitable amount of doubly distilled water to guarantee skin contact immediately before test substance application. Because of the natural moisture of the skin doubly distilled water was used for moistening, so that the test was carried out unter conditions as physiological as possible.

FORM OF APPLICATION
minimally moistened with doubly distilled water

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

A 1077 INRA (SPF)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: ca. 6 months
- Weight at study initiation: 3.62 - 4.01 kg
- Housing: the animals were housed in fully air-conditioned rooms
- Diet (e.g. ad libitum): Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): the animals were housed in fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol and Lutrol / water (1 : 1).
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
Immediately after removal of the patch, approx. 1, 24, 48 and 72 hours after removal of the patch and then in weekly intervals maximally up to day 14

SCORING SYSTEM:
- Method of calculation: For evaluation, the calculation of the mean values of erythema and edema for readings at 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account. The evaluation is based on the criteria of the Commission Directive 67/548/EEC and the OECD Harmonized Integrated Classification System that were in place on the date of report signature.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Slight erythema (grade 1) was observed in all animals immediately and 1 hour after removal of the patch.
The cutaneous reactions were reversible in all animals within 24 hours after removal of the patch.
Mean scores over 24, 48 and 72 hours for each animal were 0.0 for erythema and for edema.

Any other information on results incl. tables

Table 1: Irritant response data for each individual animal at each observation time as well as calculation of the means

Readings	Animal	Exposure period: 4 h
		Erythema	Edema	Additional findings
0 h	01	1	0
	02	1	0
	03	1	0
1 h	01	1	0
	02	1	0
	03	1	0
24 h	01	0	0
	02	0	0
	03	0	0
48 h	01	0	0
	02	0	0
	03	0	0
72 h	01	0	0
	02	0	0
	03	0	0
Mean 24 – 72 h	01	0.0	0.0
	02	0.0	0.0
	03	0.0	0.0
Mean		0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Considering the described cutaneous reactions as well as the average score for irritation, the test substance does not show a skin irritation potential under the test conditions chosen.

Executive summary:

The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of an amount of 0.5 g of the test substance for 4 hours to the intact skin of three White New Zealand rabbits, using a patch of 2.5 cm x 2.5 cm, covered with semiocclusive dressing. After removal of the patch the application area was washed off.

The cutaneous reactions were assessed immediately after removal of the patch and approximately 1, 24, 48 and 72 hours after removal of the patch.

Slight erythema was observed in all animals immediately and 1 hour after removal of the patch.

The cutaneous reactions were reversible in all animals within 24 hours after removal of the patch.

The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and 0.0 for edema.

Considering the described cutaneous reactions as well as the average score for irritation, the test substance does not show a skin irritation potential under the test conditions chosen.