Copper cyanide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

Since the LLNA is the preferred method for new in vivo testing, the use of the standard guinea pig tests to obtain new data on the skin sensitisation potential of a substance will be acceptable only in exceptional circumstances and will require scientific justification. However, existing data of good quality that were generated before 10 May 2017, or for which the study was initiated before 10 May 2017, and derived from such tests are acceptable. Here, the study has begun by the end of year 2016.

Test material

Test material information

Constituent 1

Reference substance name:

Copper cyanide

EC Number:

208-883-6

EC Name:

Copper cyanide

Cas Number:

544-92-3

Molecular formula:

CCuN

IUPAC Name:

λ¹-copper(1+) iminomethanide

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

64%

Day(s)/duration:

6 hours 3 times with a 1 week interval

Challenge

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

64%

Day(s)/duration:

6 hours

No. of animals per dose:

20 animals for the test article treatment group
10 animals/control groups (vehicle and positive control groups)

Positive control substance(s):

yes

Remarks:

DNCB

Results and discussion

Positive control results:

In all animals of positive control group, discrete or patchy erythema (grade 1), moderate and confluent erythema (grade 2) or intense erythema and swelling (grade 3) were observed, and the sensitization rate was 100 %. Therefore, sensitization potential of positive control group fell in the category of ‘very strong (grade V)'.

In vivo (non-LLNA)

Results

Key result

Group:

test chemical

Dose level:

64%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

There were no test article-related abnormal clinical signs.

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There were no test article-related clinical signs or abnormal body weight changes, and no skin reactions were recorded for the vehicle control group and the test article-treated group.
On the other hand, in positive control group, erythema was observed and the sensitization rate was 100 %. Therefore, sensitization potential of positive control group fell in the category of ‘very strong (grade V)'.
Based on the above results, under present experimental conditions, no dead animals, test article-related abnormal clinical signs or body weight changes were observed, and the sensitization rate was 0 % in the test article treatment group. Therefore, the sensitization potential of Copper cyanide (Copper(I) cyanide) was very weak (grade I).