Amines, polyethylenepoly-, tetraethylenepentamine fraction

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1974-1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Short summary of acute oral toxicity test, no GLP, no data on composition of the test substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Eyes not staining with 5% fluorescein in 20 sec contact were accepted. Single installation of 0.005, 0.02, 0.10 or 0.5 mL undiluted or 0.5 mL of 40, 15, 5 or 1% dilutions were made into conjunctival sac of 5 rabbits. Read immediately unstained and after fluorescein at 24 h, with one of 10 grades assigned. Trace or no injury from 0.5 mL undiluted is grade 1.

GLP compliance:

no

Remarks:

Before GLP

Test material

Test material information

Constituent 1

Reference substance name:

Amines, polyethylenepoly-, tetraethylenepentamine fraction

EC Number:

292-587-7

EC Name:

Amines, polyethylenepoly-, tetraethylenepentamine fraction

Cas Number:

90640-66-7

Molecular formula:

C8H23N5, C10H25N5

IUPAC Name:

(2-aminoethyl)[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amine; bis(2-aminoethyl)({2-[(2-aminoethyl)amino]ethyl})amine

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

No info, at least up to 24 h.

Number of animals or in vitro replicates:

5

Results and discussion

In vivo

Results

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h

Score:

5

Max. score:

10

Reversibility:

not specified

Remarks on result:

other: moderate corneal injury

Any other information on results incl. tables

Only a description of the results was given:

- 0.02 mL per eye: moderate corneal injury with iritis in 1/5 rabbits

- 0.005 mL per eye: minor injury

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Because 0.02 mL of the undiluted test substance caused moderate corneal injury, it is expected that the amount required according the current OECD guideline (0.1 mL) will induce more severe eye injury and the test substance is therefore considered to be at least 'highly irritating'.

Executive summary:

The test substance, Amines, polyethylenepoly-, tetraethylenepentamine fraction, was applied undiluted at a volume of 0.02 mL to the conjunctival sac of 5 rabbits. Rabbits showed moderate corneal injury, 1/5 rabbits showed iritis. A volume of 0.005 mL per eye showed minor injury. Because a volume of 0.02 mL was used, it is expected that the amount required according the current OECD guideline (0.1 mL) will induce more severe eye injury and the test substance is therefore considered to be at least 'highly irritating'. Because of lack on info when using a volume of 0.1 mL, and on reversibility, classification in OECD-GHS categories is not possible.