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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-03-18 to 1997-04-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well documented GLP based study according to standard procedure guideline

Data source

Reference

Reference Type:

other:

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Version / remarks:

(40 CFR Part 798.1100 Toxic Substances Control Act, Health Effects Testing Guidelines- Subpart B)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

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:

not specified

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

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Davidson Mill Breeding Labs in Jamesburg, NJ
- Age at study initiation:no data
- Weight at study initiation:2.00 - 2.28 kg
- Fasting period before study:no
- Housing:stainless steel cages with indirect bedding
- Diet: Lab Diet Certified Rabbit Diet 5322 ad libitum
- Water: ad libitum
- Acclimation period: six days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65 to 75
- Humidity: was monitored
- Photoperiod: 12 hour light/dark cycle

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure:mid-dorsal area of the trunk, between scalpulae and pelvis
- % coverage: 10%
- Type of wrap if used: porous gauze dressing and non-irritating tape, entire trunk was encased in impermeable plastic wrap fixed with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently with water
- Time after start of exposure: 14 days

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg of animal body weig
- For solids, paste formed: no

Duration of exposure:

24h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1,3,6 and 24 hours after treatment start and daily thereafter for a total of 14 days, dermal observations were recorded at 24 h
- Frequency of weighing: at day7 and terminally
- Necropsy of survivors performed: yes (all animals)
- Other examinations performed: clinical signs, body weight, histopathology
- Sacrificing: by intravenous injection of pentobarbital sodium

Statistics:

none, as no effects have been observed

Results and discussion

Preliminary study:

none

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: at limit dose of 2000 mg/kg bw no toxic effects were detectable

Mortality:

No dead rabbits were observed.

Clinical signs:

other: There were no clinical signs or dermal findings during the study.

Gross pathology:

There were no gross necropsy findings for any examined tissues.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the authors of the study report, Propargyl-N-butylcarbamat was interpreted to have no dermal toxicity.

Executive summary:

The acute dermal toxicity of Propargyl-N-butylcarbamat

was determined using rabbits according to a standard test guideline. The limit dose of 2000 mg/kg bw was used for the test. At this limit dose, no deaths, clinical signs, dermal findings, or significant body weight changes have been observed. Hence, the LD50 value was found to be greater than 2000 mg/kg bw.