Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Experimental data was reviewed by the ECETOC Task Force, author of the JACC Report No. 53, “Cyanides of Hydrogen, Sodium and Potassium, and Acetone Cyanohydrin (CAS No. 74-90-8, 143-33-9, 151-50-8 and 75-86-5)”, 2007. The report is a weight of evidence approach to an extensive body of literature, much of which was undertaken prior to development of guidelines. The report was peer reviewed by the scientific non-governmental organization (NGO), which judged the data to be reliable with restrictions.
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Comparative acute toxicity of hydrogen cyanide and its salts
Author:
Ballantyne B
Year:
1984
Bibliographic source:
Proceedings of the Fourth Annual Chemical Defense Bioscience Review. Lindstrom R (ed) U.S. Army Medical Research Institute of Chemical Defense, MD
Reference Type:
publication
Title:
Acute percutaneous systemic toxicity of cyanides
Author:
Ballantyne B.
Year:
1994
Bibliographic source:
J Toxicol – Cut and Ocular Toxicol 13:249-262.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Animals were exposed to a solution of cyanide via a specially-designed application vessel attached to the shaved and depilitated skin, intact and abraded. Observations were made of clinical signs and death, and time to these signs was noted.
GLP compliance:
not specified
Test type:
other:
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified
Sex:
female

Administration / exposure

Type of coverage:
other: specially-designed phalanges for attachment of vessel containing HCN
Details on dermal exposure:
Exposed skin was depilitated, and a glass application vessel was attached using double-sided adhesive EEG electrode disks, cut in the middle to allow direct exposure. Solutions of cyanide were instilled into the well of the application chamber using a calibrated pipette, after which it was seals. A volume of 0.1 ml/kg was used. Animals were slightly restrained during the exposure, after which the cylinders were removed and the chambers washed out.
Duration of exposure:
up to 6 hours
No. of animals per sex per dose:
9-10
Control animals:
not specified
Details on study design:
The skin of some rabbits was abraded; the remaining rabbits' skin was intact.
Statistics:
95% Confidence Limits calculated

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 2.34 mg/kg bw
95% CL:
> 2.02 - < 2.61
Remarks on result:
other: in abraded skin
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 6.89 mg/kg bw
95% CL:
> 6.43 - < 7.52
Remarks on result:
other: in intact skin
Mortality:
50%
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
very toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 by the dermal route to rabbits with intact skin was 6.89 mg/kg bw. The LD50 in rabbits with abraded skin was 2.34 mg/kg bw. The onset of symptoms was rapid, within minutes.