2-Propanol, 1-butoxy-3-(2-propen-1-yloxy)-

Endpoint summary

Description of key information

Acute dermal irritation/corrosion study:

Reactions from severe erythema (beef redness) to eschar formation preventing grading of erythema with slight edema (score:4/2) noted immediately after patch removal.

This became severe erythema (beef redness) to eschar formation preventing grading of erythema with severe edema (score:4/4).

Necroses and scars noted from the epidermis to the dermis.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

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

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.

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.

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.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

other justification

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

From the results described in the Acute Dermal-Irritation study in rats it has been concluded that the test substance is corrosive and classified as Category 1 in the GHS classification.

The eye irritation study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes.