tert-butyl 3-oxobutanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Range-Finding Toxicity Data: List VI

Author:

Smyth et.al

Year:

1962

Bibliographic source:

American Industrial Hygiene Association Journal, 1962

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the extent of ocular injury caused by the test chemical in animals

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethyl-3-oxobutyramide

EC Number:

218-059-8

EC Name:

N,N-dimethyl-3-oxobutyramide

Cas Number:

2044-64-6

Molecular formula:

C6H11NO2

IUPAC Name:

N,N-dimethyl-3-oxobutanamide

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report):N,N-dimethyl-3-oxobutanamide- Molecular formula:C6H11NO2- Molecular weight :129.158 g/mol- Substance type:Organic- Physical state:Liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5ml

Duration of treatment / exposure:

no data available

Observation period (in vivo):

no data available

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

no data available

Details on study design:

TEST SITEArea of exposure: eye% coverage: No dataType of wrap if used: no wrap used REMOVAL OF TEST SUBSTANCEWashing (if done): no dataTime after start of exposure: no dataSCORING SYSTEM:Grade 1 indicates at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn from 0.005 ml, and Grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water or propylene glycol

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: no data available

Score:

2

Max. score:

10

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No irritation observed

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Acute toxicity studies were carried out to estimate the toxicity of the test chemical.Primary Eye Irritation score for the test chemical was Grade 2.Based on the grade, the test chemical was considered to be not irritating to eyes.

Executive summary:

Acute toxicity studies were carried out to estimate the toxicity ofthe test chemical.

Eye injury in rabbits was recorded in a 10- grade ordinal series and was based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical. Grade 1 indicates at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn from 0.005 ml, and Grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water or propylene glycol.

Primary Eye Irritation score after 24 hours for the test chemical was Grade 2.

Based on the grade, the test chemicalwas considered to be not irritating to eyes.