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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 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 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: JMAFF guidelines (2000); including most recent partial revisions

Test guideline 4

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

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%
- Lot/batch no.: Lot 30045
- Expiration date of the lot/batch: 01 June 2006
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Other: Molecular weight: 610. pH (1% in water) 9.8

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: At least 1.0 kg
- Housing: Individual labeled cages with perforated floors
- Diet (e.g. ad libitum): ad libitum to a controlled amount (approx 100g/day)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 21.8 degrees C
- Humidity (%): 34-80% (optimal maximum humidity level is 70%, but these fluctuations were considered not to have affected study integrity).
- Air changes (per hr): approximately 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark
IN-LIFE DATES: From: 13 June 2005 To: 11 July 2005

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

The test substance was ground to a powder using a mortar and pestle prior to weighing

Controls:

other: one eye was treated with the test article, the other eye served as a control

Amount / concentration applied:

Amount(s) applied (volume or weight with unit): mean weight of 44.7 mg (a volume of approximately 0.1ml)

Duration of treatment / exposure:

treatment duration lasted for a few seconds during instillation of test article in the conjuctival sac of one eye. The test article remained in the eye for 24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours and 7 days after instillation of test article

Number of animals or in vitro replicates:

3 animals per sex per dose

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 2% fluorescein in water (adjusted to pH 7.0 was instilled into both eyes of each animal to qantify corneal epithelial damage.
- Time after start of exposure: 24 hours
SCORING SYSTEM: Numerical scoring system assessing corneal irritation, area of conrea involved, IRIS, conjunctival irritation, Chemosis and Discharge.
TOOL USED TO ASSESS SCORE: biomicroscope used to assess scores when standard lighted was inadequate, fluorescein used to assess corneal damage.

Results and discussion

In vivo

Results

Irritation parameter:

conjunctivae score

Remarks:

and irritation, corneal opacity, iris irritation

Basis:

other: draize scoring (0-4)

Time point:

other: 24, 48 and 72 hours and 7 days post exposure

Score:

>= 0 - <= 2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: No iridial irritation or corneal opacity were observed. No corneal epithelial damage was observed after treament of fluorescein. Conjunctival irritation consisted of redness, chemosis and discharge which reversed through 2 days.

Irritant / corrosive response data:

There was no evidence of ocular corrosion.

Other effects:

Scores of zero were noted at all time points for iris and corneal irritations. Scores of 2 were noted for conjunctival irritation through 72 hours.

Any other information on results incl. tables

Animal 1 (#680)

	Cornea			Iris	Conjunctivae
Time after dosing	Opacity (0-4)	Area (0-4)	Fluor area (%)	(0-2)	Redness (0-3)	Chemosis (0-4)	Discharge (0-3)	Comments
1 hour	0	0		0	1	1	1	Remnants of test substance in eye
24 hours	0	0	0	0	2	2	2	Remnants of test substance in eye
48 hours	0	0		0	2	1	1
72 hours	0	0		0	2	0	0
7 days	0	0		0	0	0	0

 

Animal 2 (#698)

	Cornea			Iris	Conjunctivae
Time after dosing	Opacity (0-4)	Area (0-4)	Fluor area (%)	(0-2)	Redness (0-3)	Chemosis (0-4)	Discharge (0-3)
1 hour	0	0		0	2	2	1
24 hours	0	0	0	0	2	2	0
48 hours	0	0		0	1	1	0
72 hours	0	0		0	1	0	0
7 days	0	0		0	0	0	0

 

Animal 3 (#700)

	Cornea			Iris	Conjunctivae
Time after dosing	Opacity (0-4)	Area (0-4)	Fluor area (%)	(0-2)	Redness (0-3)	Chemosis (0-4)	Discharge (0-3)	Comments
1 hour	0	0		0	2	2	1	Remnants of test substance in eye
24 hours	0	0	0	0	2	1	1
48 hours	0	0		0	1	0	0
72 hours	0	0		0	1	0	0
7 days	0	0		0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: OECD GHS and EC criteria for classficiation and labelling of dangerous substances and preparations

Conclusions:

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

Executive summary:

The acute eye irritation/corrosion of the test article was assessed based on OECD 405, EC Council Directive 67/548/EEC, EPA OPPTS 870.2400 and JMAFF guidelines (2000). Single samples of approximately 45 mg of the test article (volume approx. 0.1 ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 days after instillation. Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 7 days. Remnants of the test substance were present in the eye on day 1 and/or 2. Based on these results, the test article does not have to be classified and has no obligatory labelling requirement for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals of the United Nations and EC criteria for classification and labelling requirements for dangerous substances and preparations.