bis(O,O-2-ethylhexyl-thiophosphoryl)polysulfide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Remarks:

study was conducted prior to the implementation of REACH and adoption of suitable in vitro methods

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-11-06 - 1995-11-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

OECD Guideline for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion". Adopted: 24 February 1987.

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

bis(O,O-2-ethylhexyl-thiophosphoryl)polysulfide

EC Number:

605-708-9

Cas Number:

174125-93-0

Molecular formula:

n.a.

IUPAC Name:

bis(O,O-2-ethylhexyl-thiophosphoryl)polysulfide

Test material form:

liquid

Remarks:

Orange/brown

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire. England
- Age at study initiation: approximately 11 to 13 weeks
- Weight at study initiation: 2.6 to 3.1 kg
- Housing: The rabbits were selected without conscious bias for the study. They were housed individually in metal cages with perforated floors.
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet was provided ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: All rabbits were acclimatised to the experimental environment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Animal room temperature was maintained at approximately 19°C.
- Humidity (%): Relative humidity was maintained at 30 ± 70%.
These environmental parameters were recorded daily.
- Air changes (per hr): Air exchange was maintained at approximately 19 air changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.

The albino rabbit was chosen as it has been shown to be a suitable model for eye irritation studies and is the animal recommended in the test guideline.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Single instillation into the lower everted lid of one eye, no wash-out

Observation period (in vivo):

1 week

Number of animals or in vitro replicates:

3 animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no wash-out

SCORING SYSTEM:
Ocular irritation was assessed using the prescribed numerical system:
Cornea
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
Conjunctivae
Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis (lids and/or nictating membranes)
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4

TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld light.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Remarks:

individual values: 0.0 / 0.0 / 0.0

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Remarks:

individual values: 0.0 / 0.0 / 0.0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0.89

Max. score:

2

Reversibility:

fully reversible within: Day 4

Remarks on result:

other:

Remarks:

individual values: 2.0 / 0.33 / 0.33

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Remarks:

individual values: 0.0 / 0.0 / 0.0

Irritant / corrosive response data:

OCULAR RESPONSES
No corneal damage or iridial inflammation was observed.
A diffuse crimson colouration of the conjunctivae was seen in all three animals.
The eyes were normal two and four days after instillation.

Other effects:

- Lesions and clinical observations: There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

EU implementation

Conclusions:

The study was conducted under GLP according to OECD TG 405 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies. Hence, the results can be considered as sufficiently reliable to assess the irritating properties of the test item.
Testing revealed the following scores from gradings at 24, 48 and 72 hours in the three individual animals: 0.0 / 0.0 / 0.0 (cornea opacity score), 0.0 / 0.0 / 0.0 (iris score), 2.0 / 0.33 / 0.33 (conjunctivae score (redness)), 0.0 / 0.0 / 0.0 (chemosis score). The eyes were normal two and four days after instillation.
According to Regulation (EC) 1272/2008 table 3.3.2, a substance must be classified as Irritating to eyes (Category 2), if, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 1 and/or
— iritis ≥ 1, and/or
— conjunctival redness ≥ 2 and/or
— conjunctival oedema (chemosis) ≥ 2
— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
Hence, the above mentioned criteria for classification according to Regulation (EC) 1272/2008 as eye irritant are not met.

Executive summary:

A study was performed to assess the eye irritation potential of Bis(O,O-2-ethylhexy3-thiophosphoryl)polysulfide to the rabbit. The method followed was that described in: OECD Guideline for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion". Adopted: 24 February 1987.

Three rabbits were each administered a single ocular dose of 0.1 ml of the test substance and observed for seven days after instillation.

A single instillation of the test item into the eye of the rabbit elicited transient well-defined conjunctival irritation only. All reactions had resolved two or four days after instillation. Scores of the three individual animals were 0.0 / 0.0 / 0.0 (cornea opacity score), 0.0 / 0.0 / 0.0 (iris score), 2.0 / 0.33 / 0.33 (conjunctivae score (redness)), 0.0 / 0.0 / 0.0 (chemosis score).

The substance does not need to be classified as eye irritant according to Regulation (EC) 1272/2008.