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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study does not meet the requirements of 40 CFR Part 160, and differs in the following ways. 1. This study references, and is based upon, that portion of the present submission entitled Subchronic Toxicity Study -90-days, OPPTS870.3250. and this subchronic study does meet 40 CFR Part 160.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
- This study references, and is based upon, that portion of the present submission entitled Subchronic Toxicity Study -90-days, OPPTS870.3250.
GLP compliance:
yes
Test type:
other:
Limit test:
no

Test material

Constituent 1
Chemical structure
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]

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Details on dermal exposure:
see executive summary
Duration of exposure:
6 hours for 90 days
Doses:
20, 200 and 2000 mg/kg/day
No. of animals per sex per dose:
10 rats/sex
Control animals:
yes
Details on study design:
see executive summary
Statistics:
not applicable as no death occurred

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
see executive summary
Clinical signs:
see executive summary
Gross pathology:
see executive summary

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

The toxicity study of tetraacetylethylenediamine (TAED) when delivered by dermal application once daily for six hours to the skin

of Sprague Dawley rats for 90 days is submitted to fulfill the acute toxicity requirement Guideline OPPTS870.1200 (see reference

study, Subchronic dermal toxicity study - 90 - day, Guideline OPPTS870.3250, TherImmune Study No.1152 - 103 for

complete study, Chapter 7.5). All data requirements for the acute study are fulfilled in the subchronic study, including the maximum

dose that may be applied to the animals.

In this study, groups of 10 rats/sex received TAED at levels of 20, 200, or 2000 mg/kg/day and a group of 10 rats/sex received the vehicle, 1% carboxymethylcellulose. All groups received their doses once daily for six hours to the skin. Parameters evaluated were

mortality / morbundity; clinical observations / physical examinations; body weight and food consumption; ophthalmoscopic

examinations; hematology, coagulations, and chemistry; organweights; and necropsy and histopathology findings.

One control male, two 200mg/kg/day females,and one 2000 mg/kg/day female did not survive to termination. These deaths were considered to be the result of the wrapping procedure and not the result of TAED, since no clinical signs suggestive of TAED were

noted prior to death.

No treatment related findings were noted at the 0, 20, or 200 mg/kg/day dose levels in clinical observations, body weight and food

consumption, ophthalmologic findings, clinical pathology, gross necropsy and organ weights. The only treatment-related finding was found at the high dose, 2000 mg/kg/day, was a minimal centrilobular hypertrophy (cytomegaly) in 8 of 10 and 4 of 10 males and females, respectively. Minimal centrilobular hypertophy was not noted in the lower dosed rats that died on study or had gross lesions associated with the liver.

Based on the effects in this study, tetraacetylethyldiamine (TAED), when administered to Sprague-Dawley rats, dermally for

6 hours / day for 90 days, produced a no-effect level that would be equal to or greater than 200 mg/kg/day.