Amines, polyethylenepoly-, tetraethylenepentamine fraction

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

publication

Title:

Dermal corrosion, the Corrositex system: a DOT accepted method to predict corrosivity potential of test materials

Author:

Gordon VC, Harvell JD, Maibach HI

Year:

1994

Bibliographic source:

Altern. Methods Toxicol. 10, 37-45

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Amines, polyethylenepoly-, tetraethylenepentamine fraction

EC Number:

292-587-7

EC Name:

Amines, polyethylenepoly-, tetraethylenepentamine fraction

Cas Number:

90640-66-7

Molecular formula:

C8H23N5, C10H25N5

IUPAC Name:

(2-aminoethyl)[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amine; bis(2-aminoethyl)({2-[(2-aminoethyl)amino]ethyl})amine

Test material form:

liquid

Specific details on test material used for the study:

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

In vitro test system

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

Results and discussion

In vitro

Results

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

Applicant's summary and conclusion

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).