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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:
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:
2013
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

1
Chemical structure
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
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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