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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
Study period:
1975, not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, not carried out according to recognised guideline, although results documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 16 CFR 1500. 40
Deviations:
not specified
Principles of method if other than guideline:
The acute dermal toxicity study (single exposure) was conducted on adult albino rabbits selected from healthy, acclimated animals, as described in 16 CFR 1500. 40. No other information is specified.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Specified only as Product No . X-50; Kronitex 50 ; Lot 5-101.
No other information on the test material is provided within the report.

Test animals

Species:
rabbit
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
The acute dermal toxicity study (single exposure) was conducted on adult albino rabbits selected from healthy, acclimated animals, as described in 16 CFR 1500. 40. No other information is specified.

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data.
Duration of exposure:
14 days.
Doses:
10000 mg/kg
No. of animals per sex per dose:
No data.
Control animals:
not specified
Details on study design:
No data.
Statistics:
No data.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths.
Clinical signs:
No data.
Body weight:
No data.
Gross pathology:
No data.
Other findings:
None

Any other information on results incl. tables

Mortality data

Dose level mg/kg

No. rabbits dosed

deaths per day

Mortality after 14 days

1

2

3

4

5

6

7

8

9

10

11

12

13

14

10000

5 (Intact skin)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0/5

 

10000

5 (Abraded skin)

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0/5

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance demonstrated a 0% mortality rate and has been completed as a limit test at 10000 mg/kg. The LD50 is considered to be >10000 mg/kg.
Executive summary:

The test sample was dosed dermally to 5 animals with intact skin and 5 animals with abraded skin at a dose of 10000 mg/kg. Assessed over a 14 day period, 0 deaths occured and the study was completed as a limit test. The LD50 is considered >10000 mg/kg.

No classification is applicable based on the results.