Registration Dossier
Registration Dossier
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EC number: 268-626-9 | CAS number: 68131-73-7
Endpoint summary
Administrative data
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
- 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.
Reference
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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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