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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-02-17 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 798.4500 (Acute Eye Irritation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye 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:

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Davidson Mil Breeding Labs, Jamesburg, NJ
- Age at study initiation: about 3 month
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: stainless steel cages
- Diet: ad libitum Lab Diet Certified Rabbit Diet 5322
- Water: ad libitum
- Acclimation period: 5 days prior test initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65° to 75° F
- Humidity (%): monitored, but no detailed data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): single dose of 0.1 ml per eye (only one eye per rabbit)
-The contralateral eye, remaining untreated, served as control.


VEHICLE
- No vehicle, substance used as received

Duration of treatment / exposure:

24 hours (unwashed after application)

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

6 (3 males and 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of all animals remained unwashed for 24 hours.


SCORING SYSTEM:
- According to Draize scale; mean daily scores were determined.

TOOL USED TO ASSESS SCORE: fluorescein sodium, hand held ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Total score

Basis:

mean

Time point:

other: 1 hour

Score:

7

Results 2

Irritation parameter:

other: Total score

Basis:

mean

Time point:

other: 24 hours

Score:

1

Results 3

Irritation parameter:

other: Total score

Basis:

mean

Time point:

other: 48 hours

Score:

0

Results 4

Irritation parameter:

other: Total score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Irritant / corrosive response data:

Shortly after injection (1 h), most rabbits showed effects in the Conjunctivae namely "vessels definitely above normal", "more diffuse, crimson red, individual vessels not easily discernible", "swelling above normal" and slight discharge. These effects subsided in all rabbits on the third day after substance application. Hence, the test item elicited minimal to mild conjunctival irritation. No fluorescin retention was noted at any interval.

Other effects:

The animals did not exhibit any abnormal clinical signs for the duration of the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information At 1 hour conjunctival redness = 2 in 4 out of 6 animals. However the score was less than 2 after 1 day and therefore, no classification is warranted in accordance with EU-CLP regulation table 3.3.2. Criteria used for interpretation of results: EU

Conclusions:

Propargyl-N-butylcarbamat elicited minimal to mild conjunctival irritation. No fluorescin retention was noted at any interval. The animals did not exhibit any abnormal clinical signs for the duration of the study.

Executive summary:

The eye irritation of the test item Propargyl-N-butylcarbamat

was determined by investigation of the ocular irritation in rabbits according to the EPA guideline EPA OTS 798.4500 (Acute Eye Irritation). Shortly after injection (1 h), most rabbits showed effects in the Conjunctivae. These effects subsided in all rabbits on the third day after substance application. Hence, the test item elicited minimal to mild conjunctival irritation. No fluorescin retention was noted at any interval. Moreover, the animals did not exhibit any abnormal clinical signs for the duration of the study.