Registration Dossier
Registration Dossier
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EC number: 225-967-8 | CAS number: 5187-23-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 June 1992 - 27 Aug 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : animals not fully observed for reversibility of effects
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-ethyl-1,3-dioxane-5-methanol
- EC Number:
- 225-967-8
- EC Name:
- 5-ethyl-1,3-dioxane-5-methanol
- Cas Number:
- 5187-23-5
- Molecular formula:
- C7H14O3
- IUPAC Name:
- (5-ethyl-1,3-dioxan-5-yl)methanol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch 9201; clear/colourless liquid
Test animals
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: Møllegard Breeding Centre ApS, Ekby, DK-4623 Lille Skensved
Age at study initiation: Not reported
Weight at study initiation: 2.3 - 2.5 kg
Housing: Kept in single PPL cages, 45 x 55 cm, with perforated floor
Diet (e.g. ad libitum): Rabbits had free access to feed pellets "Altromin 2123"
Water (e.g. ad libitum): Free access to drinking water acidified to pH 2.5 with hydrochloric acid
Acclimation period:At least one week
ENVIRONMENTAL CONDITIONS
Temperature (°C): 21 ± 3°C
Humidity (%): 55 ± 15%
Air changes (per hr): 10
Photoperiod (hrs dark / hrs light): 12 hours light per day (from 06h to 18h)
IN-LIFE DATES
From: 22 June 1992
To: 26 June 1992
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
Amount(s) applied (volume or weight with unit): about 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours. Observations made half an hour after removal of the dressings, and also 24, 48, and 72 hours after application of the test substance.
- Number of animals:
- 4
- Details on study design:
- TEST SITE
Area of exposure: Two patches 2.5 x 2.5 cm on each animal
Type of wrap if used: Gauze patches were secured with a cross of 1 cm wide adhesive tape, and fixed with Scanpor tape, 4.5 cm width, loosely wound round the trunk. The test site was clipped as closely as possible with an electric clipper on the day before the experiment.
REMOVAL OF TEST SUBSTANCE
Washing (if done): Skin was cleaned with soap and lukewarm water after removal of the dressings
Time after start of exposure: 4 hours
SCORING SYSTEM:
Consistent with system described in OECD test guideline 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Rabbit no. 5684
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- other: Slight erythema present during 72 hours observation period
- Remarks on result:
- other: Slight erythema seen in one animal from 24 hours onwards, still observed after 72 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Rabbit No. 5685
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No findings noted up to 72 hours
- Remarks on result:
- other: No indication of erythema
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Rabbit No. 5686
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No findings noted up to 72 hours
- Remarks on result:
- other: No indication of erythema
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- Rabbit No. 5689
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No findings up to 72 hours
- Remarks on result:
- other: No indication of erythema
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Rabbit No. 5684
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No findings up to 72 hours
- Remarks on result:
- other: No indication of Oedema
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Rabbit No. 5685
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No findings up to 72 hours
- Remarks on result:
- other: No indication of Oedema
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Rabbit No. 5686
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No findings up to 72 hours
- Remarks on result:
- other: No indication of Oedema
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- Rabbit No. 5689
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No findings up to 72 hours
- Remarks on result:
- other: No indication of Oedema
- Irritant / corrosive response data:
- Very slight erythema was seen on one rabbit which persisted for the duration of the observation period; no signs of erythema or oedema were seen in any of the other three rabbits.
- Other effects:
- No other effects reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- A very mild irritant response was seen in one rabbit: the substance is not classified according to CLP.
- Executive summary:
An acute dermal irritation test was performed by Scantox, Denmark on behalf of Perstorp Polyols, Sweden (subcontracted through Toxicon, Sweden), to determine the skin irritant properties of the test substance CTF to rats. The study was conducted to GLP and according to OECD Test Guideline 404. The neat liquid test substance was applied to the skin of four female rabbits for a period of four hours. Observations of the irritant response were made shortly after the removal of the test substance, and 24, 48, and 72 hours after exposure. Very slight erythema was seen on one rabbit which persisted for the duration of the observation period (24 -72 hours); no signs of erythema or oedema were seen in any of the other three rabbits. It was concluded that CTF should not be classified as irritating to skin under the CLP Regulation.
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