Cyclohex-1,4-ylenedimethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 May 2002 - 29 May 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study (OECD)

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,4-cyclohexanedimethanol (CHDM)

IUPAC Name:

1,4-cyclohexanedimethanol (CHDM)

Constituent 2

Reference substance name:

Cyclohex-1,4-ylenedimethanol

EC Number:

203-268-9

EC Name:

Cyclohex-1,4-ylenedimethanol

Cas Number:

105-08-8

Molecular formula:

C8H16O2

IUPAC Name:

cyclohexane-1,4-diyldimethanol

Constituent 3

Reference substance name:

[4-(hydroxymethyl)cyclohexyl]methanol

IUPAC Name:

[4-(hydroxymethyl)cyclohexyl]methanol

Details on test material:

- Name of test material (as cited in study report): 1,4-cyclohexanedimethanol
- Substance type: pure active substance
- Physical state: White waxy solid
- Analytical purity: Min 99%
- Impurities (identity and concentrations): not available
- Composition of test material, percentage of components: 99%
- Isomers composition: not applicable
- Purity test date: not available
- Lot/batch No.: 0090
- Expiration date of the lot/batch: 31 March 2003
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not determined
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Highgate Farm, Market Rasen, Lincolnshire, England.
- Age at study initiation: At least 8 weeks
- Weight at study initiation: 3.03kg - 3.63kg
- Housing: housed individually in stainless steel cages with perforated floors at the Eye Research Centre, Eye, Suffolk, IP23 7PX.
- Diet (e.g. ad libitum): Special Diet Services STANRAB (P) SQC pellet
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: At leat 18 days
-Identification: Each animal was identified by a numbered tag placed through the edge of one ear. This identification was unique within the Department throughout the duration of the study. Each cage was identified by a coloured label displaying the study number, animal number, phase of study and initials of the study Director and Home Office licensee.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15- 23
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (06:00-18:00 GMT)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the test substance
- Concentration (if solution): not applicable

Duration of treatment / exposure:

three exposures (of three minutes, one or four hours duration)

Observation period:

at approximately 1, 24, 48, 72 hours after administration

Number of animals:

three animals used.

Details on study design:

TEST SITE
- Area of exposure: 2-ply 25mm x 25mm
- % coverage: 100
- Type of wrap if used: Tubigrip elasticated bandage dressing
-Application site: dorsolumbar region og each rabbit

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with lukewarm water (30-40 degrees) to remove any residual test substance
- Time after start of exposure: at end of exposure period

SCORING SYSTEM:



No erythma and eschar 0
Very slight erythema (barely perceptibla) 1
Well-defined erythema 2
Moderate to severe erythema 3
Servere drythema (beet redness) or eschar formation (injuries in depth) 4



No erythma 0
Very slight erythema (barely perceptibla) 1
Slight oedema (edges of area well-defined by definite rasing) 2
Moderate oedema (edges raised approximately 1 millimetre) 3
Servere oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3976

Time point:

other: 24, 48, and 72 hours

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal: 3977

Time point:

other: 24, 48, and 72 hours

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal: 3998

Time point:

other: 24, 48, and 72 hours

Score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal: 3976

Time point:

other: 24, 48, and 72 hours

Score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal: 3977

Time point:

other: 24, 48, and 72 hours

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal: 3998

Time point:

other: 24, 48, and 72 hours

Score:

0

Irritant / corrosive response data:

No dermal irritation was observed in any animal throughout the duration of the study.

Other effects:

There was no sign of toxicity or ill health in any rabbit during the observation period

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Since there was no skin irritation, it can be conclued that CHDM has no dermal toxic effect.

Executive summary:

A study was performed to assess the skin irritation potential of CHDM to the rabbit. Three rabbits received a single four, semi-occlusive, dermal administration of approximately 0.5 g of the test substance as supplied and were observed for four days. No dermal irritation was observed in any animal throughout the duration of the study.