Tributyl-2-methoxypropylphosphonium salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 June 2005 to 05 August 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines (2000) including the most recent partial revisions.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

MTDID 3285

IUPAC Name:

MTDID 3285

Details on test material:

- Name of test material (as cited in study report:MTDID 3285
- Substance type: Light brown waxy chunks
- Physical state: Solid
- Analytical purity: Minimum 86%
- Purity test date: 01 June 2006
- Lot/batch no.: Lot 30045
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Other:Molecular weight: 610

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- animals of male sex
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Fasting period before study: none stated
- Housing:- Diet (e.g. ad libitum): approx 100 g/day standard laboratory rabbit diet.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-21.6 degrees C
- Humidity (%): 35-80%; higher than optimal conditions, but not considered to have an affect on study integrity
- Air changes (per hr): approximately 15 per hour.
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent artifical light/12 hours dark
IN-LIFE DATES: From: 7 June 2005 To: 24 June 2005

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: shaved: 150 square centimeters of the dorsal fur was clipped

Vehicle:

other: corn oil

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams.
- Concentration (if solution): test article only moistened with 0.4 ml vehicle.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4 mL

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after exposure for irritation. Toxicity was observed once daily and mortality/viability observed twice daily. Body weights were meaured prior to application on the day of treatment and at termination.

Number of animals:

3 animals per sex per dose

Details on study design:

TEST SITE
- Area of exposure: test article applied using a metalline patch of 2 x 3 cm.
- % coverage: not stated
- Type of wrap if used: Metalline patch monted on micropore tape, which wrapped around the abdomena and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleaned using corn oil
- Time after start of exposure: 4 hours
SCORING SYSTEM: numerical scoring system assessing erythema and eschar formation (scale 0-4) and edema formation (scale 0-4)

Results and discussion

In vivo

Results

Irritation parameter:

other: erythema score and eschar and edema formation

Basis:

other: draize scoring (0-4)

Time point:

other: 1, 24, 48 and 72 hours

Score:

>= 0 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 48 hours in one animal and 72 hours in the other animals

Remarks on result:

other: Mean edema scores were all zero

Irritant / corrosive response data:

There was no evidence of a corrosive effect on the skin. Four exposure of the test article resulted in very slight or well-defined eryhtema and very slight edema in the treated skin-areas of the three rabbits.

Other effects:

Scores of 0 were noted for edema at 24 hours and beyond and for erythema at 72 hours. Scores of 2 for erythema were noted at 1 hour.

No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.

Any other information on results incl. tables

Animal	1 (# 684)		2 (#686)		3 (#687)
Time after exposure	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 hour	2	1	1	1	2	1
24 hours	1	0	1	0	1	0
48 hours	1	0	0	0	1	0
72 hours	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information

Conclusions:

Based on these results, the test article does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals of the United Nations and EC criteria for classification and labeling requirements for dangerous substances and preparations.

Executive summary:

The primary skin irritation/corrosion of the test article was assessed in the rabbit (4-hour semi-occlusive application). The study was carried out based on the guidelines OECD 404, EC, Council Directive 67/548/EEC, An. V, B.4 (2004), "Acute Toxicity:Dermal Irritation/Corrosion" US EPA OPPTS 870.2500 (1998), Acute Dermal Irritation and JMAFF Guidelines (2000) including the most recent partial revisions. Three rabbits were exposed to 0.5 grams of the test article, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. Exposure to the test article resulted in very slight edema in the treated skin-areas of the rabbits, which had resolved within 48 hours after exposure in one animal and within 72 hours after exposure in the other animals. Based on these results, the test article does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals of the United Nations and EC criteria for classification and labeling requirements for dangerous substances and preparations.