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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

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
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
no data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute percutaneous absorption test
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
female
Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
no data
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: After treatment, the rabbits appeared listless and had slight tremors. However, both recovered, appeared healthy, and gained weight during the 2-week observation period.
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
The LD50 via the dermal route appeared to be in excess of 2000 mg/kg bw.
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).

  

The acute percutaneous absorption potential is low; range-finding tests indicate the LD50 is>2000 mg/kg. Two female rabbits were treated with 2000 mg/kg of the test material in an acute percutaneous absorption test. After treatment, the rabbits appeared restless and had slight tremors. However, both recovered, appeared healthy and gained weight during the 2-week observation period.

 

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, polyethylenepoly-
EC Number:
268-626-9
EC Name:
Amines, polyethylenepoly-
Cas Number:
68131-73-7
Molecular formula:
Not applicable (i.e., complex UVCB substance)
IUPAC Name:
Amines, polyethylenepoly-
Details on test material:
Polyethylenepolyamine, neutralized
Reference number 30339-23-485
a reaction product of E-100, EDC, 5EPI/DETA, and NaOH, also known as PAPA+1 (neutralized)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

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

Results and discussion

In vivo

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.

Applicant's summary and conclusion

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.