2-piperazin-1-ylethylamine

Endpoint summary

Description of key information

One key study was identified to determine the irritation/corrosivity of aminoethylpiperazine (AEP) to the skin and and another key study to the eyes of rabbits. 
Neat AEP is corrosive to the rabbits’ skin. The neat material also causes extensive irritation to the eyes resulting in blindness.  Ten percent solution produced moderate irritation in rabbits’ skin and produced slight but reversible conjunctivitis in rabbits’ eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2e: Meets generally accepted scientific standards, well-documented and acceptable for assessment

Principles of method if other than guideline:

Conducted prior to OECD and EC guidelines

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No data

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Not applicable

Duration of treatment / exposure:

Undiluted material was applied to the intact skin of a rabbit belly for 20 minutes.

Observation period:

Not applicable

Number of animals:

Not applicable

Details on study design:

Not applicable

Remarks on result:

other: The animal was sacrificed following first routine application due to severe damage to the belly.

Irritation parameter:

edema score

Remarks:

ear

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Irritation parameter:

edema score

Remarks:

intact abdomen

Basis:

animal #2

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Animal sacrificed - damage too great.

Irritation parameter:

edema score

Remarks:

abraded abdomen

Basis:

animal #3

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Animal sacrificed - damage too great.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

probability of severe irritation

Remarks:

animals 2 and 3 were sacrificed due to sever skin damage

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

probability of severe irritation

Remarks:

animals 2 and 3 were sacrificed due to sever damage on the skin

Irritant / corrosive response data:

Not applicable

Other effects:

Slight hyperemia and necrosis was observed after a single application.

Not applicable

Interpretation of results:

other: Severe damage to the belly

Conclusions:

The undiluted material has a severe effect upon intact skin. Contact to exposed skin for a matter of 15 or 20 minutes is likely to produce a mild burn. It is of utmost importance to avoid skin contact with the undiluted material.

Executive summary:

Not applicable

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2e: Meets generally accepted scientific standards, well-documented and acceptable for assessment.

Principles of method if other than guideline:

Conducted prior to guideline

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: Two drops
- Concentration (if solution): N/A

Duration of treatment / exposure:

The right eye is washed (within 30 seconds) for 2 minutes in a flowing stream of tepid water.

Observation period (in vivo):

1 hour; 24 hours; 48 hours; and 7 days

Number of animals or in vitro replicates:

Two per dose level

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washed and unwashed
- Time after start of exposure: The right eye is washed (within 30 seconds) for 2 minutes in a flowing stream of tepid water.

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: Immediate

Score:

<= 3

Max. score:

3

Reversibility:

not specified

Remarks on result:

other: LEFT EYE (UNWASHED) RESPONSE - PAIN 4; CONJUNCTIVA 3; CORNEA 2. RIGHT EYE (WASHED) RESPONSE - PAIN 2; CONJUNCTIVA 3; CORNEA 2.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: Immediate

Score:

<= 2

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: LFT EYE (UNWASHED)-CONJUNCTIVA(Soft tissue necrotic & swollen) 6 ; CORNEA: BEFORE STAIN 4; AFTER STAIN 4; INTERNAL EFFECTS 3 (IRITIS). RT EYE (WASHED)-CONJUNCTIVA 4; CORNEA: BEFORE STAIN 1; AFTER STAIN 4; INTERNAL EFFECTS 3 (IRITIS)

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: After 24 hours

Score:

<= 6

Max. score:

6

Reversibility:

not specified

Remarks on result:

other: LEFT EYE (UNWASHED)-CONJUNCTIVA 6 ; CORNEA: BEFORE STAIN 5; AFTER STAIN 5; INTERNAL EFFECTS No data. RIGHT EYE (WASHED)-CONJUNCTIVA 5; CORNEA: BEFORE STAIN 4; AFTER STAIN 4; INTERNAL EFFECTS 3 (IRITIS)

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 hours

Score:

<= 4

Max. score:

4

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: After 48 hours

Score:

<= 5

Max. score:

5

Reversibility:

not specified

Remarks on result:

other: LEFT EYE (UNWASHED)-CONJUNCTIVA 5 ; CORNEA: BEFORE STAIN 5; AFTER STAIN 4; INTERNAL EFFECTS No data. RIGHT EYE (WASHED)-CONJUNCTIVA 5; CORNEA: BEFORE STAIN 4; AFTER STAIN 3; INTERNAL EFFECTS 3 (CLOUDY & IRITIS)

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 48 hours

Score:

<= 5

Max. score:

5

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: After 7 days

Score:

<= 5

Max. score:

5

Reversibility:

not specified

Remarks on result:

other: LEFT EYE (UNWASHED)-CONJUNCTIVA 5 ; CORNEA: BEFORE STAIN 5; AFTER STAIN 4; INTERNAL EFFECTS 5 (Cloudy). RIGHT EYE (WASHED)-CONJUNCTIVA 5; CORNEA: BEFORE STAIN 4; AFTER STAIN 3; INTERNAL EFFECTS 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 7 days

Score:

<= 5

Max. score:

5

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

probability of severe irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

probability of severe irritation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

probability of severe irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

probability of severe irritation

Irritant / corrosive response data:

Extensively irritating to conjunctiva and cornea. Note: The washed eye was slightly less damaged than the unwashed. Iritis was also noted at the 24 hour time point.

Other effects:

Permanent blindness produced.

Neat material: Extensively irritating to conjunctiva and cornea. Permanent blindness produced. The washed eye was slightly less damaged than the unwashed.

10% solution: Slight conjunctivitis, essentially subsided in 24 hours.

Interpretation of results:

highly irritating

Remarks:

Migrated information

Conclusions:

The undiluted material is severely damaging to the eye. Gross contamination is most likely to result in permanent loss of vision. It is important to emphasize that immediate washing (15 seconds or less) is essential if the degree of damage is to be reduced. Chemical workers goggles should be worn where the likelihood of gross contamination exists.

These conclusions are based upon range finding toxicological tests and are limited to precautions for industrial handling of the material. Development of specific uses will require consideration of the health problems presented and of the need for further toxicological studies.

Executive summary:

Neat material: Extensively irritating to conjunctiva and cornea. Permanent blindness produced. The washed eye was slightly less damaged than the unwashed.
10% solution: Slight conjunctivitis, essentially subsided in 24 hours

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Neat aminoethylpiperazine (AEP) is corrosive to the rabbits’ skin and causes extensive irritation to the eyes resulting in blindness. Ten percent solution in propylene glycol produced moderate irritation in rabbits’ skin and produced slight but reversible conjunctivitis in rabbits’ eyes.

Justification for classification or non-classification

Aminoethyl piperazine meets the criteria for classification as Corrosive, sub category 1B according to the GHS criteria since necrosis was seen at the 20 minute time point rather than the 3 minute time point.