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Toxicological information

Skin irritation / corrosion

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
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

Test material

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: Not specified
- 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:

Test animals

Species:
rat
Strain:
other: AlPk
Details on test animals or test system 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).

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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.

Any other information on results incl. tables

None

Applicant's summary and conclusion

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.