Amines, polyethylenepoly-, tetraethylenepentamine fraction

Endpoint summary

Description of key information

Amines, polyethylenepoly-, tetraethylenepentamine fraction is corrosive.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

unknown

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Review paper with many chemicals tested, therefore no specific details available

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)

Principles of method if other than guideline:

This study was carried out for validation of the OECD 435 testing guideline.

GLP compliance:

not specified

Specific details on test material used for the study:

100%
pH of 10% solution is 11.85
No further details given

Test system:

artificial membrane barrier model

Vehicle:

unchanged (no vehicle)

Details on test system:

SOURCE AND COMPOSITION OF MEMBRANE BARRIER USED
- Was the Corrositex® test kit used: yes
- Components: dermal biobarrier and chemical detection system
- Apparatus and preparation procedures: not specified

WAS THE COMPATIBILITY TEST PERFORMED: yes

WAS THE TIMESCALE CATEGORY TEST PERFORMED: not specified

TEMPERATURE USED DURING TREATMENT: not specified

METHOD OF DETECTION
Chemical Detection System (CDS). The CDS consists of multiple chemical detectors which have demonstrated responsiveness with over 32 classes of chemicals.

METHOD OF APPLICATION: not specified

NUMBER OF REPLICATES: not specified

NUMBER OF INDEPENDENT EXPERIMENTS TO DERIVE FINAL PREDICTION: not specified

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if a color change occured after 1 hour to 4 hours (Cat. 1C), after 3 minuntes and 1 hour (Cat. 1B) and in less than 3 minutes (Cat. 1A)
- The test substance is considered to be non-corrosive to skin if no color change occured after 4 hours
- Justification for the selection of the cut-off point(s): according to guideline

Control samples:

other: evaluation for 75 chemicals and comparing to the in vivo data

Amount/concentration applied:

not specified

Duration of treatment / exposure:

until color change occurs

Number of replicates:

not specified

Irritation / corrosion parameter:

penetration time (in minutes)

Value:

61

Vehicle controls validity:

not examined

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Other effects / acceptance of results:

Test result of Tetraethylenepentamine (concentration neat, pH 11.85) showed a color change after 61 minutes (mean) without a standard deviation given

Interpretation of results:

other: CLP/EU GHS Category 1B (H314) according to Regulation (EC) No 1272/2008

Conclusions:

Based on this in vitro test, Amines, polyethylenepoly-, tetraethylenepentamine fraction should be classified as corrosive Cat. 1B (DOT Packaging Group II).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion:

An in vitro skin irritation study is available with Amines, polyethylenepoly-, tetraethylenepentamine fraction (Gordon, 1994). This study was carried out for validation purposes of the OECD 435 testing guideline. The Corrositex ® test kit was used. Only a summary table is available. Amines, polyethylenepoly-, tetraethylenepentamine fraction was tested as neat substance. The test substance showed a full-thickness destruction of the biobarrier membrane after 1 hour and 1 minute. Based on the definition given in the publication this would lead to a Corrosive Packing Group III which is equivalent to CLP/EU Category 1C. It was however indicated that the standard deviation was “not done” which seems to mean that it was tested only once. With a possible variation of e.g. a few minutes for such a one hour period it can be speculated that Amines, polyethylenepoly-, tetraethylenepentamine fraction could be classified as borderline between Cat. 1B and 1C. Ethylenediamine (100%) showed a barrier breakthrough of 13 minutes with a standard deviation of 30 seconds, resulting in classification into PG II (CLP corrosion Cat. 1B).  Amines, polyethylenepoly-, triethylenetetramine fraction showed a barrier breakthrough at 49 minutes (with a standard variation of 1.19 min) and as such should be classified in Cat. 1B. Although it was indicated that Amines, polyethylenepoly-, triethylenetetramine fraction was tested as a 60% concentration, but considering that breakthrough time seems to increase with increasing length of the ethylene amines (order EDA, TETA, TEPA), the results for 100% TETA can be expected also to fall into Cat. 1B. Considering the available data, classification in Cat. 1B seems most appropriate for Amines, polyethylenepoly-, tetraethylenepentamine fraction.

Two further skin irritation studies performed pre-GLP and pre-guideline with the registration substance are available (Myers, 1979 and Dow, 1965). The information on the study design is very limited and no detailed scores are reported. However, the test substance was applied to the bellies of rabbits. In one study 3 of 5 rabbits necrosis was observed (Myers, 1979) leading to the conclusion that the test substance is corrosive. In the second study the test substance led to crustations which healed without scars.

Based on the observed results the registration substance is considered to be corrosive to skin (Cat. 1B).

 

Eye irritation

Only limited data is available with Amines, polyethylenepoly-, tetraethylenepentamine fraction. Two eye irritation studies performed pre-GLP and pre-guideline with the registration substance indicate that the test substance might have eye damaging properties (Myers, 1979 and Dow, 1965). Since no information on the study design and no detailed scores are reported, those studies cannot be used for a final hazard conclusion. However, as described above Amines, polyethylenepoly-, tetraethylenepentamine fraction is considered to be corrosive to skin thus no further testing is required.

Justification for classification or non-classification

Reliable data with the registration substance on skin irritation indicate 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). As the registration substance is classified as corrosive to skin and thus leading to a classification as serious eye damage (Cat. 1, H318). No further testing on eye irritation is required.