2-piperazin-1-ylethylamine

Endpoint summary

Description of key information

The acute oral LD50 in rats is 2140 mg/kg and the 24 hour dermal LD50 in rabbits is 866 mg/kg.  

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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

Qualifier:

no guideline available

Principles of method if other than guideline:

Groups of 5 male rats were dosed with the test material at various doses and observed for 14 days

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Carworth-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Animals were reared in the laboratory the study was conducted at and maintained on Rockland rat diet.

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

Test material was administered by oral gavage.

Doses:

Rats were dosed with 1.0, 2.0, 3.98 or 7.95 ml/kg AEP.

No. of animals per sex per dose:

5 males

Control animals:

not specified

Details on study design:

Carworth-Wister non-fasted rats, 5-6 weeks of age and 90-120 grams in weight were dosed at levels differing by a factor of 2.0 in a geometric series.

Statistics:

Thompson's method of calculating the median-effective dose (LD50) was applied to the 14-day mortality data.

Preliminary study:

Not applicable

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2 097 mg/kg bw

Mortality:

Two of five rats died at 2.0 ml/kg and all rats died at 3.98 and 7.95 ml/kg. All animals died within 24 hours.

Clinical signs:

other: No additional information available.

Gross pathology:

At necropsy, lungs were found to be slightly congested, livers mottled, kidneys congested internally but pale externally, and stomach, intestine and adrenal hemorrhaged.

Other findings:

No additional information available.

The oral LD50 was calculated to be 2.14 ml/kg. Given a density of 0.98 g/cc, the oral LD50 is considered to be 2097 mg/kg.

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The acute oral LD50 was 2097 mg/kg.

Executive summary:

The acute oral toxicity of aminoethylpiperazine was determined. The acute oral LD50 was 2097 mg/kg.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 140 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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

Qualifier:

no guideline available

Principles of method if other than guideline:

Essentially followed the method of Draize et al.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

Groups of four male New Zealand white rabbits, 3 to 5 months of age and averaging 2.5 kg were used.

The rabbits were procured locally and maintained on Rockland rabbit ration.

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

The fur is removed and the test material applied beneath an impervious plastic film

Duration of exposure:

The test material is in contact for 24 hours after which the plastic film is removed and the rabbits are held for a 14-day observation period.

Doses:

0.625 or 1.25 ml of test material/kg

No. of animals per sex per dose:

4 males/dose

Control animals:

not specified

Details on study design:

Rabbits were immobilized during the 24-hour skin contact period. Thereafter, the "Vinylite" sheeting used to retain the dose in contact with the clipped skin of the trunk was removed and the animals were caged for the remainder of the 14-day observation period.

Statistics:

Thompson's method of calculating the LD50 was used.

Preliminary study:

Not applicable

Sex:

male

Dose descriptor:

LD50

Effect level:

866 mg/kg bw

Mortality:

One of three male rabbits dosed with 0.625 ml/kg died and two of three male rabbits dosed with 1.25 ml/kg died. All deaths occurred within 2 days.

Clinical signs:

other: No additional information available.

Gross pathology:

Congestion of the lungs, mottling of the livers and pitting or speckling of the kidney surfaces was observed (not stated whether this was in the survivors or animals that died).

Other findings:

No additional information available.

These covered applications produced necrosis of the skin, congestion of the lungs, mottling of the livers and pitting or speckling of the kidney surf aces.

Aminopropyl rnorpholine has a comparable value of 1.2 m l /kg. and diethylene trimine 1.1 ml/kg.

Interpretation of results:

Category 3 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The 24 hour dermal LD50 was 0.88 ml/kg (866 mg/kg).

Executive summary:

By skin penetration on rabbits the LD50 is 0.88 (0.34 to 2.3) ml/kg (866 mg/kg). This is to be expected because of the necrotic action of the mixture on rabbit skin which destroys the skin barrier entirely.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

866 mg/kg bw

Additional information

The acute oral toxicity of aminoethyl piperazine is relatively low. The most realible study shows an LD50 in the rat of 2140 mg/kg. Other studies indicate LD50s >1000 mg/kg. The acute dermal LD50 is 866 mg/kg bw. Due to the low vapor pressure of the material, no inhalation LC50 was determined.

Justification for classification or non-classification

The substance has an acute oral LD50 of 2140 mg/kg and therefore meets the criteria for GHS acute oral toxicity class 5. EU is not adopting category 5; therefore, we consider AEP as not classifiable.

However, Annex VI to the CLP Regulation, as updated with the 1st ATP, indicates that AEP carries a GHS category 4 classification for the acute oral endpoint; therefore this classification will be used.

The substance has a acute dermal LD50 of 866 mg/kg bw and therefore meets the criteria for GHS acute dermal toxicity class of 3 and will be used.

Annex VI to the CLP REgulation, as updated with the 1st ATP, indicates that AEP carries a GHS category 4 classification for the acute dermal endpoint; along with an asterisk notation. This means the GHS category 4 is a minimum classification and a more strict classification should be applied if the manufacture has information to support this.