Polyethylene polyamine, pentaethylenehexamine fraction

Endpoint summary

Description of key information

There are only limited data available on the acute oral toxicity and no data on the acute dermal or inhalation toxicity of polyethylene polyamine, pentaethylenehexamine fraction. The substance is classified as corrosive thus no further information according to the standard information requirements in Annex VII and VIII of the Reach Regulation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1963

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

Only a summary table with results.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Rats were fed differenct doses of test material and the LD50 was estimated.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%

Doses:

1.0, 2.0, 3.98 g/kg

No. of animals per sex per dose:

2

Control animals:

no

Sex:

not specified

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

2/2 rats died at 3980 mg/kg bw; 1/2 rats died at 2000 mg/kg bw, 0/2 rats died at 1000 mg/kg bw

Clinical signs:

other: Animals appeared normal during and after feeding of 1000 mg/kg bw of test substance. No further information is given.

Gross pathology:

At 1000 mg/kg bw gross pathology appeared essentially negative. No further information is given.

g/kg	No animals dead	Reponse-remarks
1.0	0/2	Animals appeared normal during and after feeding. Gross pathology at autopsy appeared essentially negative.
2.0	1/2	Animals died 8 days following feeding.
3.98	2/2	One animal died in 2 hours the other In 4 days.

Interpretation of results:

other: CLP/EU GHS Category 4 (H302) according to Regulation (EC) No 1272/2008

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

no data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Qualifier:

no guideline followed

Principles of method if other than guideline:

Only LD50 given in secondary literature

GLP compliance:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

1 600 mg/kg bw

Based on:

test mat.

Interpretation of results:

other: CLP/EU GHS Category 4 (H302) according to Regulation (EC) No 1272/2008

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 600 mg/kg bw

Quality of whole database:

The available information comprises a worst case.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There are only limited data available on acute oral toxicity and no data on acute dermal toxicity of polyethylene polyamine, pentaethylenehexamine fraction. The substance is corrosive therefore no further testing is required according to the standard information requirements set out in Annex VII-VIII, 8.5. of Regulation (EC) No 1907/2006

 

Oral toxicity:

An acute oral toxicity study was performed with PEHA pre-guideline and pre-GLP with rats of unknown sex (Olson, 1963, reliability 4). The study report provided only limited information. 20% of the test substance in water was administered to the two rats in each doses of 1.0, 2.0, and 3.98 g/kg bw. No mortality was observed in the lowest dose group, 1/2 died in the mid-dose group and all rats died in the highest dose group. Thus, the LD50 was set to 2000 mg/kg based on the results of this study. In a secondary literature information (Spitz, 1979) a LD50 of 1600 mg/kg bw was described for PEHA.

  

Based on the results of the acute oral toxicity studies as a worst case approach the substance is classified as harmful if swallowed.

Justification for classification or non-classification

Data on acute oral toxicity indicate that the registered substance meets the criteria for classification with Category 4 (H 302) according to Regulation (EC) No. 1272/2008. As the substance is classified as corrosive no testing via oral or inhalation route is required.