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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Butan-1-ol (Butyl alcohol) is both reagents used in the manufacture of IPETC/O-isopropyl ethylthiocarbamatel. Therefore Butan-1-ol (Butyl alcohol) need to be considered in the assessment of IPETC/ O-isopropyl ethylthiocarbamate .

Data source

Reference
Reference Type:
publication
Title:
Environmental Health Criteria 65: Butanols – Four Isomers: 1- Butanol 2-Butanol tert-Butanol Isobutanol
Author:
US Department of Health, Education and Welfare.
Year:
1987
Bibliographic source:
WHO. Registry of Toxic Effects of Chemical Substances. p.1301, 1985-86.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.41
Principles of method if other than guideline:
Six rabbits were exposed to the test substance for 24 hours under occlusive conditions (Draize-Test). The animals were observed for 8 days.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
O-isopropyl ethylthiocarbamate
EC Number:
205-517-7
EC Name:
O-isopropyl ethylthiocarbamate
Cas Number:
141-98-0
Molecular formula:
C6H13NOS
IUPAC Name:
N-ethyl(propan-2-yloxy)carbothioamide
Test material form:
liquid
Details on test material:
IPETC is prepared through reacting ethoxycarbonyl isothiocyanate/ Ethyl isothiocyanatoformate (CAS 16182-04-0) with propan-2-ol/ isopropyl alcohol (CAS Number 67-63-0) and Butan-1-ol/ butyl alcohol (CAS Number 71-36-3).

IPETC/O-isopropyl ethylthiocarbamate contains propan-2-ol (CAS number 67-63-0) and Butan-1-ol (CAS number 67-63-0) which are an integral part of the substance.
Propan-2-ol (CAS number 67-63-0) and Butan-1-ol (CAS number 67-63-0) are both reagents used in the manufacture of IPETC/O-isopropyl ethylthiocarbamate. Therefore, Propan-2-ol (CAS number 67-63-0) and Butan-1-ol (CAS number 67-63-0) need to be considered in the assessment of IPETC/O-isopropyl ethylthiocarbamate.

EC Name: propan-2-ol
CAS Number :67-63-0
EC Number:200-661-7
CAS Name: isopropyl alcohol

EC Name: Butan-1-ol
CAS Number : 71-36-3
EC Number: 200-751-6
CAS Name: butyl alcohol

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: W. Ostrop breeding facility, Germany
- Weight at study initiation: 2.7 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4-6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved or abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: flanks on an area of 8 x 8 cm on both sides
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: occlusive dressing


SCORING SYSTEM: edema and erythema formation graded from 0 to 4 (according to Draize)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: only readings on shaved skin taken into account
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
3.17
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: only readings on shaved skin taken into account

Any other information on results incl. tables

The mean value for erythema formation was 4, the mean value for edema formation was 3.17. As no full thickness necrosis was reported, the test substance is considered as irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:
other: moderately irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The mean value for erythema formation was 4, the mean value for edema formation was 3.17. As no full thickness necrosis was reported, the test substance is considered as irritating to the skin.The acute skin irritation study indicates that Butan-1-ol (Butyl alcohol) as a main constituent of IPETC/ O-isopropyl ethylthiocarbamate caused moderate irritation.
Executive summary:

The acute skin irritation study indicates that Butan-1-ol (Butyl alcohol) as a main constituent of IPETC/O-isopropyl ethylthiocarbamate caused moderate irritation.