Registration Dossier

Administrative data

Description of key information

No evidence of skin irritation was seen in a rat study following single or repeated applications of Polyol PX.  A guideline-compliant rabbit eye irritation study reports only slight and reversible irritant effects.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May - June 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was not performed to modern test guidelines (e.g. OECD, EU, US EPA) and no statement of GLP compliance was made, however the species tested and the route of exposure were considered appropriate to the endpoint under assessment, such that the data were considered reliable.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Assessment of skin irritation in the rat
GLP compliance:
not specified
Remarks:
: older propreitray study, pre-dates GLP
Species:
rat
Strain:
other: AlPk
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Animal Breeding Unit, Imperial Chemical Industries PLC, Pharmaceuticals Division, Alderley Park, Macclesfield, Cheshire
- Age at study initiation: Not reported.
- Weight at study initiation: 120 - 240 g.
- Housing: The rats were caged individually in cages divided into two equal compartments by a solid metal partition.
- Diet (e.g. ad libitum): The animals were fed ad libitum with BP PCD pellets.
- Water (e.g. ad libitum): The animals were allowed tap water ad libitum.
- Acclimation period: Not documented


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23ºC
- Humidity (%): Approximately 50 - 60% relative humidity.
- Air changes (per hr): 24
- Photoperiod (hrs dark / hrs light): 12 hours light in each 24 hour period.


IN-LIFE DATES: Not specified. (Testing done between May - June 1981).
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of test substance used as supplied per application.
- Concentration (if solution): N/A
Duration of treatment / exposure:
Duration of exposure for each application was 24 hours.
A single application was made to one group of 6 female animals.
For repeated exposure, a second group of six female rats was given a total of five applications on days 1, 3, 5, 7, and 9 and were decontaminated on days 2, 4, 6, 8, and 10 of the test.
Observation period:
The application site on each animal was examined daily for signs of irritation. The rats were kept up to seven days after the end of the final
application period.
Number of animals:
Two groups of six female rats.
Details on study design:
TEST SITE
- Area of exposure: 20 mm x 20 mm 8-ply gauze patch (4 cm²) covered by a 35 mm x 50 mm rubber patch. The patch was applied to an area of the dorso-lumbar skin.
- % coverage: Not reported.
- Type of wrap if used: Patch (as described above) was held in place by adhesive, impermeable tape (Sleek, 50 mm x 250 mm).


REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 24-hour application, the dressing was removed and the skin cleansed free of the test substance using clean swabs of absorbent cotton wool soaked in warm water.
- Time after start of exposure: Cleaning took place at the end of the 24-hour exposure period.


SCORING SYSTEM: No details provided.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Irritation parameter:
erythema score
Remarks:
Repeated dosing every other day
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: No effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment. Slight scabbing and erythema were present in some animals in the repeated application group, but this was thought to be the result of a viral infection, also present in stock animals.
Irritation parameter:
erythema score
Remarks:
Repeated dosing every other day
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment. Slight scabbing and erythema were present in some animals in the repeated application group, but this was thought to be the result of a viral infection, also present in stock animals.
Irritation parameter:
erythema score
Remarks:
Repeated dosing every other day
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment. Slight scabbing and erythema were present in some animals in the repeated application group, but this was thought to be the result of a viral infection, also present in stock animals.
Irritation parameter:
erythema score
Remarks:
Repeated dosing every other day
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: No effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment. Slight scabbing and erythema were present in some animals in the repeated application group, but this was thought to be the result of a viral infection, also present in stock animals.
Irritation parameter:
erythema score
Remarks:
Repeated dosing every other day
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment. Slight scabbing and erythema were present in some animals in the repeated application group, but this was thought to be the result of a viral infection, also present in stock animals.
Irritation parameter:
erythema score
Remarks:
Repeated dosing every other day
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment. Slight scabbing and erythema were present in some animals in the repeated application group, but this was thought to be the result of a viral infection, also present in stock animals.
Irritation parameter:
edema score
Remarks:
Repeated dosing every other day
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment.
Irritation parameter:
edema score
Remarks:
Repeated dosing every other day
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment.
Irritation parameter:
edema score
Remarks:
Repeated dosing every other day
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment.
Irritation parameter:
edema score
Remarks:
Repeated dosing every other day
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment.
Irritation parameter:
edema score
Remarks:
Repeated dosing every other day
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment.
Irritation parameter:
edema score
Remarks:
Repeated dosing every other day
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no effects of treatment
Remarks:
Evaluation of effects took place 24/72/120/168/216 h after first treatment.
Irritant / corrosive response data:
No signs of irritation were observed in any animal following a single or repeated application. However, slight scabbing and erythema were present in
some animals in the repeated application group, but this was thought to be the result of a viral infection, also present in stock animals.
Other effects:
Not reported.

None

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Polyol PX was concluded to be non-irritant to rat skin following single and repeated exposure.
Executive summary:

A study was conducted at the laboratories of Imperial Chemical Industries PLC, Macclesfield, Cheshire, UK, in 1981 to determine the skin 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. Two groups of female rats were used in the test. On each rat, an area of the dorso-lumbar skin was shaved free of hair at least 16 hours prior to the application of the test substance. In one group of rats, approximately 0.1 mL of the test material (as supplied) was applied as a single application to the skin and kept in contact with the skin for 24 hours by means of an occlusive dressing. After 24 hours the dressing was removed and the area cleaned with swabs of cotton wool soaked in warm water. In the second group of rats, approximately 0.1ml of the test substance was similarly applied to the shaved area of skin but each was given a total of 5 applications; i.e. on days 1, 3, 5, 7 and 9; with each being decontaminated (swabbed down) on days 2, 4, 6, 8 and 10 of the test. The application site on each animal was examined daily for signs of irritation and the rats were kept up to seven days after the end of the first application period. There were no signs of skin irritation observed in any animal following a single or repeated application. However, a slight scabbing and erythema were present in some animals but this is considered to be due to a viral infection which was also present in stock animals. Therefore, it was concluded that Polyol PX was non-irritant to rat skin following single and repeated exposure.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May - June 1981
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.
Qualifier:
equivalent or similar to
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
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).
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.
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
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
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 72 hours
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 72 h
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
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
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
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48 h
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
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48 h
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.

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

Interpretation of results:
not irritating
Remarks:
Migrated information 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

No evidence of skin irritation was seen in a rat study following single or repated application of Polyol PX (Nixon, 1982). While this study is not compliant with current guidelines, it clearly demonstrates that the substance is not a skin irritant. Additional testing is therefore not considered to be required.

Eye irritation

Polyol PX was found to be a mild eye irritant in a guideline-comparable rabbit study (Nixon, 1982). Findings in this study were limited to Grade 1 conjunctival erythema and oedema and were fully reversible within 72 hours. The substance is not classified as an eye irritant according to CLP.


Justification for selection of skin irritation / corrosion endpoint:
Single study available for this endpoint

Justification for selection of eye irritation endpoint:
Single study available for this endpoint

Justification for classification or non-classification

No evidence of skin irritation was seen in a rat study following single or repeated applications of Polyol PX. A guideline-compliant rabbit eye irritation study reports only slight and reversible irritant effects. No classification is therefore required for skin or eye irritation for the reaction mass of 1,3 -propanediol, 2-(hydroxymethyl)-2-[(methoxymethoxy)methyl]- and 1,3-dioxane-5,5-dimethanol according to EC Regulation 1272/2008.