N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Range-Finding Toxicity Data: List VI

Author:

Smyth H.F. and Carpenter C.P.

Year:

1962

Bibliographic source:

Am. Ind. Hyg. Ass. J., 23,|95-107

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

To evaluate the eye irritation potency of the test substance, a flooding volume (0.5 ml) was instilled directly into the eye of 5 rabbits (not rinsed). Eye injury in rabbits was then recorded in a 10-grade ordinal series and is based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine

EC Number:

229-761-9

EC Name:

N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine

Cas Number:

6711-48-4

Molecular formula:

C10H25N3

IUPAC Name:

N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine

Details on test material:

Name of test material (as cited in study report): N,N,N`,N`-Tetramethyldipropylenediamine

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
not reported


ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

Where dilution of a chemical is necessary, the preferred solvent was propylene glycol from a batch shown to cause no injury, followed by water, and in some cases a deodorized kerosene known as "Deobase" has been used.

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.005, 0.02, 0.1 or 0.5 mL. Guided by the result and the table of injury grades below, additional applications are made until the chemical can be assigned to one of the defined grades. If large volumes are applied, the lids are held closed for one minute before the animal is released.

Duration of treatment / exposure:

unrinsed

Observation period (in vivo):

18-24 h

Number of animals or in vitro replicates:

5

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM:
The individual numerical scores of eye treated with a given volume or concentration of a chemical are added together and then divided by the number of eyes (usually 5) to obtain the score injury caused by the treatment. The level of 5.0 was selected as representative of severe injury. This figure corresponds to necrosis visible only after staining and covering about three fourths of the surface of the cornea; or a more severe necrosis covering a smaller area.

1) Generally the symptoms were scored as followed:
- Symptom visible before Fluorescein staining:
cornea dull: 2 points
cornea opaque, less than half of area: 4 points
cornea opaque, more than half of area: 6 points (Maximum points)
Keratoconus: 6 points (Maximum points)
Iritis, slight internal congestion: 1 point
Iritis, marked internal congestion: 2 points (Maximum points)

- Symptom visible after Fluorescein staining:
Necrosis on less than 5% of cornea: 1 point
Necrosis on 5 to 12%: 2 points
Necrosis on 13 to 37%: 3 points
Necrosis on 38 to 62%: 4 points
Necrosis on 63 to 87%: 5 points
Necrosis on 88 to 100%: 3 points (Maximum points)

- Total maximum points: 20 points

2) The injury was then graded according to the following table:
- Grade 1: 0.5 ml undiluted gives injury of 0 to 1.0 points
- Grade 2: 0.5 ml undiluted gives injury of over 1.0 up to 5.0 points
- Grade 3: 0.1 ml undiluted gives injury of up to 5.0 points (0.5 ml gives over 5.0)
- Grade 4: 0.02 ml undiluted gives injury of up to 5.0 points (0.1 ml gives over 5.0)
- Grade 5: 0.005 ml undiluted gives injury of up to 5.0 points (0.02 ml gives over 5.0)
- Grade 6: excess of 40% solution gives injury of up to 5.0 points (0.005 ml gives over 5.0)
- Grade 7: excess of 15% solution gives injury of up to 5.0 points (40% gives over 5.0)
- Grade 8: excess of 5% solution gives injury of up to 5.0 points (15% gives over 5.0)
- Grade 9: excess of 1% solution gives injury of up to 5.0 points (5% gives over 5.0)
- Grade 10: excess of 1% solution gives injury of over 5.0 points

TOOL USED TO ASSESS SCORE: the eye is examined in strong diffuse daylight, then stained with fluorescein and the injury scored.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 18-24 h after treatment

Score:

9

Max. score:

10

Reversibility:

other: necrosis

Remarks on result:

other: The test substance was attributed to Grade 9 on a scale of 10, indicating that excess of 1% solution gives injury of up to 5.0 points (5% gives over 5.0), corresponding to necrosis on 63 to 87% of the cornea.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information