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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Test material form:
other: Black red, fine grained and free-flowing solid
Details on test material:
- Storage condition of test material: room temperature in the dark
- Analytical purity: 100 % (UVCB)

Test animals

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hour
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Clinical signs:
other: No signs of systemic toxicity
Gross pathology:
No abnormalities
Other findings:
Signs of skin irritation: slight to well defined erythema, very slight to slight oedema

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The acute dermal LD50 was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

The toxic effects of FeNaEDDHA in Sprague Dawley rats were investigated according to the OECD Guideline 402 on Acute Dermal Toxicity. The animals were dosed dermally in a limit test with a single concentration of test material at a dose level of 2000 mg/kg body weight. The test material was applied to skin of test animals and left for 24 hours in semiocclusive contact.

All animals survived the 2000 mg/kg bw dermal application. No signs of systemic toxicity were noted in treated animals. Signs of skin irritation: slight to well defined erythema and very slight to slight oedema were observed. All animals showed expected bodyweight gain during the study. At necropsy, no deviations from normal morphology were found. The LD50 is greater than 2000 mg/kg body weight.