Registration Dossier
Registration Dossier
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EC number: 260-252-4 | CAS number: 56539-66-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was conducted according to an appropriate test method and in compliance with GLP, but the purity of the samples is not known. Consequently, the reliability of the data is with restriction.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-methoxy-3-methylbutan-1-ol
- EC Number:
- 260-252-4
- EC Name:
- 3-methoxy-3-methylbutan-1-ol
- Cas Number:
- 56539-66-3
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 3-methoxy-3-methylbutan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Solfit
- Physical state: colorless liquid
- Lot/batch No.: 024141
- batch recieved on (date): 23 November 1990
- Storage condition of test material: in the dark under ambient conditions
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Limited, Abbots Ripton Road, Wyton, Huntingdon
- Age at study initiation: adult, young
- Diet (e.g. ad libitum): Standard Rabbit Diet (Special Diets Services, 1 Stepfield, Witham, Essex, CM8 3AD
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 7 days before test commencement
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 1´9 °C
- Humidity (%): 52 % rel.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: unchanged (no vehicle) and water
- Controls:
- yes
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Skin reactions were assessed 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 6 (male)
- Details on study design:
- The test and control materials (0.5 ml) were applied to intact skin on each rabbit under 2.5 cm*2.5 cm patches of gauze. The test material, Solfit, was applied at concentrations of 100% and 50% (v/v) in distilled water and 2 control material, triethyl citrate and distilled water, were also applied. Four patches were applied to each rabbit. The patches were then covered with Micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage which remained in position for 4 h. At the end of this period the patches were removed and the skin wiped with damp tissues without altering the existing response or the integrity of the epidermis.
Skin reactions were assessed 1, 24, 48 and 72 h after patch removal using the scoring system as shown below.
Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system as follows:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries 4
in depth)
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending 4
beyond the area of exposure)
Assessment of Results
The mean irritation score for each material was calculated in the following way:
The daily scores for erythema/eschar and oedema were totalled at the end of the experimental period and divided by the number of animals (6 ) and the number of time points (4 ).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 0.04
- Reversibility:
- fully reversible
- Remarks on result:
- other: 100% concentration
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: <50% concentration
Any other information on results incl. tables
Mean irritation scores were calculated to be:
| Solfit - 100% | 0.04 |
| Solfit - 50% (v/v) in distilled water | 0.00 |
| Triethyl citrate | 0.00 |
| Distilled water | 0.00 |
Primary Skin Irritation Test in Rabbits Reaction Scores:
| Rabbit number | Material | Erythema | Oedema | ||||||
| 1h | 24h | 48h | 72h | 1h | 24h | 48h | 72h | ||
| 1 | A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 2 | A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 4 | A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 5 | A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 6 | A | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| C | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
A = Solfit 100%; B = Solfit 50% (v/v) in distilled water; C = Triethylcitrate; D = Distilled water
At a concentration of 100% very slight erythema was noted at
one animal at 24 hours assessment only. No skin reactions
were noted at a concentration of 50% v/v in distilled water.
No skin reactions were noted with the control materials,
triethyl citrate and distilled water.
Interpretation of results and classification of substance Classification of the substance is based on the criteria laid down in: Regulation 1272/2008 EC, Annex I, table 3.2.2.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- In conclusion, 3-methoxy-3-methylbutan-1-ol is non-irritant to rabbit skin under the test conditions.
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