N,N'-ethylenebis[N-acetylacetamide]

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not indicated

Rationale for reliability incl. deficiencies:

other: only a brief summary published in the TAED HERA report is available

Data source

Reference

Reference Type:

grey literature

Title:

HERA-draft: Tetraacetylethylenediamine (TAED)

Author:

HERA members

Year:

2002

Bibliographic source:

http://www.heraproject.com/RiskAssessment.cfm?SUBID=2

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 427 (Skin Absorption: In Vivo Method)

Deviations:

not applicable

Remarks:

; as the test was performed before the guideline has been established and only a brief summary of the study is available, deviations cannot be excluded

GLP compliance:

no

Remarks:

, study predated GLP

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-ethylenebis[N-acetylacetamide]

EC Number:

234-123-8

EC Name:

N,N'-ethylenebis[N-acetylacetamide]

Cas Number:

10543-57-4

Molecular formula:

C10H16N2O4

IUPAC Name:

N,N'-ethylenebis[N-acetylacetamide]

Radiolabelling:

yes

Remarks:

14C at the ethylene moiety

Test animals

Species:

rat

Strain:

Wistar

Sex:

not specified

Details on test animals or test system and environmental conditions:

no further data available

Administration / exposure

Type of coverage:

not specified

Vehicle:

other: chloroform and 2 different detergent bases (detergent A base and detergent B base + perborate)

Duration of exposure:

1, 5, 10, 20 min (formulated in detergent A base), 1, 5 min (formulated in detergent B base + perborate), continuous (formulated in chloroform); animals were sacificed after 2 days

Doses:

amount of TAED applied to skin: 40 µg/cm² (detergent A base), 134.8 µg/cm² (detergent B base + perborate), 112.4 µg/cm² (chloroform)

No. of animals per group:

no data

Control animals:

no

Details on study design:

Skin penetration studies using TA[14C]ED in detergent solutions and in chloroform were conducted in rats. One group of Wistar rats was treated with 0.2 ml of a 1% w/v detergent A base containing 400 μg TA[14C]ED applied over 10 cm2 of clipped dorsal skin. A second group was treated with 200 μl of a solution containing 6% powder detergent B base, 1% perborate and 0.5% TA[14C]ED (1348 μg TA[14C]ED) and a third group was treated with 50 μl chloroform containing 1124±40μg TA[14C]ED. (see also "Remarks on results including tables and figures")

Results and discussion

Signs and symptoms of toxicity:

not specified

Dermal irritation:

not specified

Absorption in different matrices:

- Skin wash: at the end of the 1, 5, 10 and 20 min exposure period
- Skin test site: 10 cm² of clipped dorsal skin
- Urine: predominate route of excretion
- Faeces: less than 3 %

see also "Remarks on results including tables and figures"

Total recovery:

not indicated

Percutaneous absorption

Percutaneous absorption 1

Dose:

40 µg TAED/cm²

Parameter:

percentage

Absorption:

0.1 %

Remarks on result:

other: 1 min exposure

Remarks:

TAED formulated in detergent A base

Percutaneous absorption 2

Dose:

40 µg TAED/cm²

Parameter:

percentage

Absorption:

1 %

Remarks on result:

other: 10 min exposure

Remarks:

TAED formulated in detergent A base

Percutaneous absorption 3

Dose:

40 µg TAED/cm²

Parameter:

percentage

Absorption:

1.7 %

Remarks on result:

other: 20 min exposure

Remarks:

TAED formulated in detergent A base

Percutaneous absorption 4

Dose:

134.8 µg TAED/cm²

Parameter:

percentage

Absorption:

0.2 %

Remarks on result:

other: 1 min exposure

Remarks:

TAED formulated in detergent B base + perborate

Percutaneous absorption 5

Dose:

134.8 µg TAED/cm²

Parameter:

percentage

Absorption:

0.9 %

Remarks on result:

other: 10 min exposure

Remarks:

TAED formulated in detergent B base + perborate

Percutaneous absorption 6

Dose:

112.4 µg TAED/cm²

Parameter:

percentage

Absorption:

4.3 %

Remarks on result:

other: 2 day exposure

Remarks:

TAED formulated in chloroform

Any other information on results incl. tables

Skin penetration of TA[¹⁴C]ED in rats.

Vehicle	Duration of contact before rinsing (min)		Amount of TA[^14C]ED in µg/cm^2				% of applied TA[^14C]ED penetrating skin
			applied to skin		penetrating skin after 2 days
Detergent A base	1		40		0.05		0.13
	5		40		0.18		0.45
	10		40		0.39		0.98
	20		40		0.69		1.73
Detergent B base + perborate	1		134.8		0.2		0.15
	10		134.8		1.2		0.89
Chloroform	left on skin		112.4		4.8		4.27

Of the TA[¹⁴C]ED which penetrated the skin, most was recovered in the urine while less than 3% was recovered in the feces.

Applicant's summary and conclusion

Conclusions:

The results indicate, that TAED can principally penetrate rat skin to a limited extent, increased contact time leading to increased penetration.