Carbamic acid, N-butyl-, 2-propyn-1-yl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-02-7 to 1997-05-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well documented GLP based study according to EPA guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-propynyl-butylcarbamate

EC Number:

616-291-8

Cas Number:

76114-73-3

Molecular formula:

C8H13NO2

IUPAC Name:

2-propynyl-butylcarbamate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): only common name based on sponsor informaion is given, equivalent to:
Chemical name: Carbarmic acid, N-butyl-,2-propyn-1-yl ester
CAS: 76114-73-3
- Analytical purity: no data available
- Impurities (identity and concentrations): no data available
- Lot/batch No.: no data available

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Davidson Mill Breeding Laboratories in Jamesburg, New Jersey
- Age at study initiation: 3 month
- Weight at study initiation: 1.8 to 2.2 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum Lab Diet Certified Rabbit Diet 5322
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 - 23.8 °C (65° to 75° F)
- Humidity (%): was monitored,
- Photoperiod (hrs dark / hrs light): 12/12
:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): single dermal application of 0.5 ml of test article to appox. 6 square centimeters

VEHICLE
- no vehicle

Duration of treatment / exposure:

The test article was removed four hours following application.

Observation period:

14 days

Number of animals:

3 males (M) and 3 females (F)

Details on study design:

TEST SITE
- Area of exposure: 6 cm² at mid-dorsal area of the trunk, between scalpulae and pelvis
- Hair were clipped with Oster (R) small animal clipper
- Test article was covered with square surgical gauze pad (Johnson & Johnson gauze sponge) which was hold with three hypo-allergenic cloth tapes (Johnson & Johnson Dermicel)


REMOVAL OF TEST SUBSTANCE
- Washing: gently with water and paper towels
- Time after start of exposure: 4h

SCORING SYSTEM: Draize skin scoring scale

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: up to 14 days

Score:

0.42

Remarks on result:

other: mean score from all readings were averaged

Irritant / corrosive response data:

Some animals showed temporary very slight erythema as well as well-defined erythema, but all irritations subssided by 14 days. No relevant edema were observed. Hence, minimal to mild, transient irritation was noted. The animals did not exhibit any abnormal clinical signs for the duration of the study.

Any other information on results incl. tables

ER: Erythema

0: No Erythema

1: Very slight erythema

2: Well-defined erythema

Rabbit Number	4 h No. ER	24 h  No. ER	48 h  No. ER	72 h  No. ER	7 d  No. ER	14 d  No. ER
1	1	1	2	1	0	0
2	0	0	1	0	0	0
3	0	0	2	2	1	0
4	0	0	0	0	0	0
5	1	1	0	0	0	0
6	1	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The estimated primary irritation index is 0.42. Minimal to mild, transient irritation was noted. All induced erythema subsided within 14 days after exposure. The animals did not exhibit any abnormal clinical signs for the duration of the study.
According to EU classification, the item does not has to be classified
According to GHS classification, the item does not has to be classified

Executive summary:

The dermal irritation of Propargyl-N-butylcarbamat

was determined in rabbits according to the EPA guideline EPA OTS 798.4470 (Acute Dermal Irritation). The scoring was done in accordance with the method of Draize. The estimated primary irritation index was 0.42 and hence minimal to mild, transient irritation was noted. All induced erythema subsided within 14 days after exposure. The animals did not exhibit any abnormal clinical signs for the duration of the study.

The results showed short term mild irritation. The limits for classification were not surpassed. Concluding, Propargyl-N-butylcarbamat

does not have to be classified as skin irritant.