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EC number: 801-709-5 | CAS number: 53146-45-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April 2013 - 06 June 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-butoxy-3-(prop-2-en-1-yloxy)propan-2-ol
- EC Number:
- 801-709-5
- Cas Number:
- 53146-45-5
- Molecular formula:
- C10H20O3
- IUPAC Name:
- 1-butoxy-3-(prop-2-en-1-yloxy)propan-2-ol
1
- Specific details on test material used for the study:
- Description: Brown Liquid
Batch: 12D25
Purity: 94.0%
Expiry Date: 10 April 2014
Storage Conditions: Room temperature (actual values: 19.5°C-29.0°C), protected from light
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white (Kbs:JW)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11-12 Weeks old
- Weight at study initiation: 2.43 kg
- Housing: Aluminium cages
- Diet (e.g. ad libitum): Restricted feeding schedule (150 g/day) with pellet diet RC4
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9°C-24.9°C
- Humidity (%): 43.7%-58.1 %
- Ventilation: 12 times/hour
- Photoperiod (hrs dark / hrs light): 12/ 12
IN-LIFE DATES: From: To: 30 April 2013 to 02 May 2013
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL of the test substance was used as the application material in an undiluted state.
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 1, 24, and 48 hours after patch removal.
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm of impregnated lint cloth was applied to the application site
- Type of wrap if used: adhesive stretch bandage
The animal's general condition was observed once daily during the experimental period.
The animal was weighed before application on the day of application and after the completion of evaluation on the day of evaluation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 - 48 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: No data on reversibility are available, because the test was ended after 48 hours due to the observation of corrosive effects
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 - 48 hours
- Score:
- 2 - 4
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: Slight edema was observed on the initial observation and 1 hour timepoint; this increased to severe edema from the 24 hour timepoint onwards
- Irritant / corrosive response data:
- As results, necroses and scars were noted from the epidermis to the dermis. The test substance was considered corrosive and no further experiment was perfonned. No abnormality was noted in general condition, and body weight showed a satisfactory increase during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- From the results described above it has been concluded that the test substance is corrosive and classified as Category 1 in the GHS classification.
- Executive summary:
In accordance with the OECD guidance document (No. 404), an acute dermal-irritation potential of 1-butanol, reaction products with 2-[(2-propen-1-yloxy) methyl] oxirane was examined in the Yoshimi Laboratories study (No. 1323). 0.5 mL of the application material impregnated into a 2.5x2.5-cm piece of lint cloth was directly applied to the application site, and the cloth was fixed with
adhesive stretch bandage. This semi-occlusive application was kept for 4 hours, and skin reaction was evaluated immediately after and 1, 24, and 48 hours after patch removal, pursuant to the table for grading of skin reactions in the guideline.
As results, reactions from severe erythema (beef redness) to eschar formation preventing grading of erythema with slight edema were noted from immediately after patch removal.
Subsequently necroses and scars were noted from the epidermis to the dermis, indicating a corrosive effect.
Thus no further experiment was performed.
Regarding the GHS classification, the test substance is classified as Category 1 for its corrosive effect.
No abnormality was noted in general condition, and body weight showed an increase during the observation period.
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