Amines, polyethylenepoly-

Endpoint summary

Description of key information

No data are available on the skin irritation of PEPA. A limited eye irritation study is available. However a harmonised classification is available where PEPA is classified as corrosive (H314).

Key value for chemical safety assessment

Skin irritation / corrosion

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:

disregarded due to major methodological deficiencies

Study period:

no data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Short summary of test results

Reason / purpose for cross-reference:

reference to same study

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

no data

Duration of treatment / exposure:

eyes were washed and unwashed

Observation period (in vivo):

15 days

Number of animals or in vitro replicates:

no data

Irritant / corrosive response data:

Instillation of the test material into the eyes of a rabbit resulted in severe pain, moderate conjunctival irritation, and moderate, transient clouding of the cornea. No irritationwasobserved in either the washed or unwashed eye 15 days post-instillation.

Interpretation of results:

study cannot be used for classification

Conclusions:

Instillation of the test material into the eyes of a rabbit resulted in severe pain, moderate conjunctival irritation, and moderate, transient clouding of the cornea.

Executive summary:

A sample of polyethylenepolyamine neutralized, reference 30339-23-485, was submitted to the Acute Toxicology Laboratory of Health & Environmental Sciences-Texas for evaluation of acute percutaneous absorption and eye irritation potential. The test material, a reaction product of E-100, EDC,5 EPI/DETAand NaOH,also known as PAPA+1 (neutralized), was submitted by Chlor-Nitrogen Research.

 

Acute percutaneous absorption and eye Irritation tests were conducted using female Zealand albino rabbits (Ray Nichols Rabbitry).

  

Instillation of the test material into the eyes of a rabbit resulted in severe pain, moderate conjunctival irritation, and moderate, transient clouding of the cornea. No irritationwasobserved in either the washed or unwashed eye 15 days post-instillation. Chemical workers goggles should be worn whenever the likelihood of eye contact exists. If contact should occur, flush eyes with, plenty of flowing water.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There are no data available on skin irritation/corrosion and only limited data on eye irritation of polyethylenepolyamine (CAS 68131 -73 -7). The registered substance is harmonised classified as corrosive (H314). Therefore, according to the standard information requirements set out in Annex VII-VIII, 8.1 and 8.2 of Regulation (EC) No 1907/2006 nor further information is required.

Eye irritation

An eye irritation study with very limited information is available for the test substance (Dow, 1983). Since no information on the study design and no detailed scores are reported, this study cannot be used for hazard assessment and is thus disregarded. However, instillation of the test material into the eyes of a rabbit resulted in severe pain, moderate conjunctival irritation, and moderate, transient clouding of the cornea. This indicates that the substance might result in irreversible damage to the eyes.

Justification for classification or non-classification

A harmonised classification for skin irritation for PEPA is available (Skin Corr. Category 1B, H314). Reliable data from a structural analogue substance on skin and eye irritation indicates that the registered substance meets the criteria for classification according to Regulation (EC) No. 1272/2008. The test substance is therefore classified as corrosive to skin Cat. 1B (H314) and damaging to eyes Cat. 1 (H318).