N,N-bis(3-aminopropyl)methylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: No GLP, no guideline followed (published literature).

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Male rabbits were employed for eye irritation studies. Eyes to be dosed, generally five per group were examined following application of fluorescein stain to ensure that no corneal lesions were present prior to testing. The amount of test material to be used was varied according to anticipated ocular injury. For large volumes, up to 0.5 mL, liquid was instilled by syringe into the inferior conjunctival sac. Smaller volumes, as low as 0.005 mL were placed directly on the cornea with a pipette. The test material was diluted with a suitable solvent. For solid samples an excess of powder was placed in the inferior conjunctival sac or 0.5 mL of solution or suspension of test material was used. After 18-24 h,the treated eye was rinsed with water and again stained with fluorescein.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N-bis(3-aminopropyl)methylamine

EC Number:

203-336-8

EC Name:

N,N-bis(3-aminopropyl)methylamine

Cas Number:

105-83-9

Molecular formula:

C7H19N3

IUPAC Name:

bis(3-aminopropyl)(methyl)amine

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

other: undiluted and diluted with water

Controls:

not required

Amount / concentration applied:

0.005 mL undiluted test susbtance
0.5 mL 15 % solution of the test substance in water
0.5 mL 5 % solution of the test substance

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

24 hours after application

Number of animals or in vitro replicates:

5 male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours after application

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Irritation parameter:

other: cornea, iris

Basis:

mean

Time point:

other: 24 hours

Remarks on result:

other: Severe corneal opacity and iritis after treatment with undiluted (0.005 mL) test substance and 15 % solution (0.5 mL). Minor cornea opacity and iritis after treatment with 5 5 (0.5 mL) solution.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU