Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 November - 16 December 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Acute Skin Absorption LD50 Test on Rabbits
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Nickel, tetrakis[tris(3-methyl-phenyl) phosphite-P]-, mixture with tetrakis[tris(4-methylphenyl)phosphite-P]nickel

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
No data.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
See below.
Duration of exposure:
24 h
Doses:
1000, 1500, 2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
The LD50 value was calculated from mortality data, using the method of D. J. Finney:
Finney, D. J., Probit Analysis, 3rd Ed., 1971, Cambridge University Press.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 129 mg/kg bw
Based on:
test mat.
95% CL:
>= 613 - <= 1 424
Remarks on result:
other: (corresponding to 508 mg/kg bw for the submission substance)
Mortality:
See table below. All deaths occurred within 2 days after dosing.
Clinical signs:
Prostration at 1500 and 2000 mg/kg.
Body weight:
Weight loss at all dose levels tested.

Any other information on results incl. tables

Dose as received         Average wt (g)              

Sex No.     mg/kg     Avg. mL            Initial       14 Days       Mortality     (mg/kg)

Male   6    2000        5.05                   2776          -                      6/6        1129

6    1500        3.20                   2344         2625                  5/6

6     1000        2.06                  2257         2631                  2/6

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Single dermal application of the test material caused lethality in male rabbits, resulting in an LD50 of 1129 mg/kg bw (corresponding to 508 mg/kg bw submission substance only).
Executive summary:

The test substance was subject to an acute dermal LD50 test on rabbits. Doses of 1000 to 2000 mg/kg were applied to intact skin under occlusive conditions for 24 hours. Deaths occured in all dose groups within 2 days after dosing. The LD50 is 1129 mg/kg bw, corresponding to 508 mg/kg bw for the submission substance only.