Reaction mass of 1,3-dioxane-5,5-dimethanol and 1,3-Propanediol, 2-(hydroxymethyl)-2-[(methoxymethoxy)methyl]-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1981- 04 Mar 1982 (report issue date)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study not performed to current international guidelines (e.g. OECD, EU, US EPA, etc) and no claim of GLP compliance has been made, however the species tested and the route of exposure were broadly consistent with accepted tests, and the level of detail in the report was sufficient to consider the data to be essentially reliable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

A group of three male New Zealand White Rabbits were used in the test. Approximately 0.1 mL of the test substance (as supplied) was instilled into oneeye of each rabbit and the lids held together for 1 -2 seconds immediately after which the animal was released. The contralateral eye served as a
control. Immediately after instillation, the rabbit was observed and an assessment of any initial pain caused by the test substance was made
according to a six point scale. The eyes were examined and the grade of ocular reaction at 1 -2 hours, 1, 2, 3, 4 and 7 days after instillation was
recorded according to the Draize scale (Draize 1959) and a modified form of the system described by Kay and Calandra (1962) was used to interpret and classify the numerical scores.

GLP compliance:

not specified

Remarks:

: older proprietary study, pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Polyol PX

IUPAC Name:

Polyol PX

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Polyol PX
- Substance type: Manufacturing intermediate.
- Physical state: Yellow / brown viscous liquid.
- Analytical purity: Not reported.
- Impurities (identity and concentrations): Not reported.
- Composition of test material, percentage of components: Not reported.
- Isomers composition: Not reported.
- Purity test date: Not reported.
- Lot/batch No.: Not reported.
- Expiration date of the lot/batch: Not reported.
- Stability under test conditions: Not reported.
- Storage condition of test material: Not reported.
- Other:Not reported.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Near Oldham, Lancashire, UK.
- Age at study initiation: Not specified.
- Weight at study initiation: Between 2.5 - 3.0 kg.
- Housing: The rabbits were housed in satinised aluminium sheet cages (605mm width x 490mm depth x 455mm height) with one animal per cage.
The floor of each cage was a perforated aluminium sheet and the doors were transparent (Polycarbonate).
- Diet (e.g. ad libitum): The animals were fed ad libitum with BP PCD pellets.
- Water (e.g. ad libitum): The animals had ad libitum access to tap water.
- Acclimation period: A minimum of six days prior to the start of the experiment.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 20ºC.
- Humidity (%): 50 - 60% Relative humidity.
- Air changes (per hr): 24
- Photoperiod (hrs dark / hrs light): 12 hours of light per 24 hour period.


IN-LIFE DATES: Not specified (experiments performed during May and June 1981).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: No additional animals used - the untreated eye in each animal tested served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL.
- Concentration (if solution): N/A


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of treatment / exposure:

Single exposure, as follows;
Approximately 0.1ml of the test substance was instilled into one eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were then gently held together for 1-2 seconds and the animal released. The other eye, remaining untreated., served as a control.

Observation period (in vivo):

7 days.

Number of animals or in vitro replicates:

3 male rabbits.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported.
- Time after start of exposure: N/A


SCORING SYSTEM:
Immediately after instillation, the rabbit was observed and an assessment of any initial pain caused by the test substance was made according to a
six-point scale (Appendix 3).
The eyes were examined and the grade of ocular reaction at 1-2 hours, 1, 2, 3, 4 and 7 days after instillation was recorded according to the Draize scale (Draize 1959, Appendix 4). A modified form of the system described by Kay and Calandra (1962, Appendix 5) was used to interpret and classify thenumerical scores.

Refer to report appendices attached in Attachment 1.

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - Not specified, although fluorescein was used in pretreatment examinations.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 14

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 15

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 16

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 17

Irritation parameter:

iris score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 18

Irritation parameter:

iris score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 19

Irritation parameter:

iris score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 20

Irritation parameter:

iris score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 21

Irritation parameter:

iris score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 22

Irritation parameter:

iris score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 23

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 24

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 25

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 26

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 27

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 28

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

48 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 29

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 30

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 31

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 32

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 33

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 34

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 h

Results 35

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 36

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 37

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 38

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: no effects

Results 39

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 40

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Immediately following instillation, all animals showed signs of severe initial pain (4 on a 0 - 5 scale). One to two hours after instillation all animals showed signs of slight conjunctivitis including redness, chemosis and discharge. However, all animals had recovered by day 3. There was no corneal or iridial involvement in any animal.

Other effects:

Conjunctival discharge was also noted at up to 48 hours.

Any other information on results incl. tables

Irritation scores

Observation		1h	24h	48h	72h	Mean (24-72h)	4d	7d
Cornea	Opacity	0,0,0	0,0,0	0,0,0	0,0,0	0.00	0,0,0	0,0,0
Iris	Lesion	0,0,0	0,0,0	0,0,0	0,0,0	0.00	0,0,0	0,0,0
Conjunctivae	Erythema	1,1,1	1,1,1	1,1,1	0,0,0	0.67	0,0,0	0,0,0
	Chemosis	1,1,1	0,1,1	0,0,0	0,0,0	0.22	0,0,0	0,0,0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Polyol PX is a mild irritant to the rabbit eye. All effects seen were fully reversible within 72 hours (3 days) of exposure.

Executive summary:

A study was conducted at the laboratories of Imperial Chemical Industries PLC, Macclesfield, Cheshire, UK, in 1981 to determine the eye irritant potential of the test substance Polyol PX. The study was not performed to any OECD Test Guidelines and no claim of GLP compliance was made. A group of three male New Zealand White Rabbits with no apparent eye defects noted prior to the dose application were used in the test. Approximately 0.1ml of the test substance (as supplied) was instilled into one eye of each rabbit and the lids held together for 1 -2 seconds immediately after dose instillation, before the animal was released. The contralateral eye served as a control. Immediately after instillation, the rabbit was observed and an assessment of any initial pain caused by the test substance was made according to a six point scale. The eyes were examined and the grade of ocular reaction at 1 -2 hours, 1, 2, 3, 4 and 7 days after instillation was recorded according to the Draize scale. Immediately following instillation, all animals showed signs of severe initial pain (4 on a 0-5 scale). One to two hours following instillation, all animals showed signs of slight conjunctivitis, including redness, chemosis and discharge but all animals had recovered by day 3. There was no corneal or iridial involvement in any of the 3 animals. It was concluded therefore, that Polyol PX is a mild irritant to the rabbit eye, and does not require classification under CLP.