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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
experimental phase was conducted between 08 July 2004 and 08 August 2004. The report was issued 20 September 2004.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Pre-existing study.

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetracopper hexahydroxide sulphate
EC Number:
215-582-3
EC Name:
Tetracopper hexahydroxide sulphate
Cas Number:
1333-22-8
Molecular formula:
Cu4H6O10S
IUPAC Name:
tetracopper(2+) hexahydroxide sulfate
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Male and female Hartley albino guinea-pigs obtained from S.C.E.A (24610 Villefranche-de-Lonchat, France) were used for the study. A total of nine animals were used for the preliminary testing and 16 for the main test. The animals were acclimatised for at least 5 days before the beginning of the test. They weighed less than or equal to equal to 500 g (main test).

Identification: each animal was identified individually by auricular ring and the corresponding number was written on a label put on its cage.

Housing: the animals were housed at the rate of 1 per cage, in 31 cm x 46 cm x 19 cm polypropylene cages with stainless steel lid. The litter renewed regularly was composed of dust-free wood shavings. The cages were placed in limited-access premises, of 7 m x 4 m x 3 m, maintained in slight over-pressure (a minimum of 10 mm of water), under air-conditioned temperature (t = 21 ± 3°C) and controlled relative humidity (RH = SO ± 20 %) except during washing cycles. Air changes of non-recycled filtered air was performed at the rate of about 10 cycles per hour. The artificial lighting ensured a sequence of 12 hours light, 12 hours dark.

Feeding: food was supplied in pelleted form 106, which guaranteed an appropriate ascorbic acid content and was sourced from UAR (91360 Epinay sur orge, France).

Drinking: the tap water was distributed in polypropylene bottles with stainless steel teat. A sample of water is taken at least every six months and subject for chemico-physical and bacteriological analysis at a specialist laboratory.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
other: distilled water
Concentration / amount:
80%, 0.1 ml
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: distilled water
Concentration / amount:
80% / 0.2ml
Day(s)/duration:
2
No. of animals per dose:
Control = 5.
Treated = 10.
Details on study design:
Intradermal injections

Control group = group 1
Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region cleared of hair on each side of the midline.

1) FCA diluted at 50 % with distilled water (v/v)
2) Distilled water (vehicle)
3) mixture 50/50 of the solutions 1 and 2 (v/v)

Treated group = group 2
Three pairs of intradermal injections of 0.1 ml volume were given in the same sites and order as in the control animals.

1) FCA diluted at 50 % with distilled water (v/v)
2) test item at the dose previously defined (MICm)
3) test item at the same dose as in 2 in a 50/50 mixture (v/v) of FCA and distilled water (v/v) (the mixture was homogenized by successive suckings and forcings back with a syringe without needle).

In injection 3, the water soluble test item was dissolved in the aqueous phase prior to mixing with FCA. Injections 1 and 2 were given close to each other and nearest the head, while the injection 3 was given towards the caudal part of the test area.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
80%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None reported.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
80%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None Reported
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
80%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None reported
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None reported.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None reported
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
None reported.
Key result
Reading:
other: The positive control was run as a separate study to confirm the responsiveness of the test animals.
Hours after challenge:
48
Group:
positive control
Dose level:
20% w/w
No. with + reactions:
10
Total no. in group:
10

Any other information on results incl. tables

Main Test.

 

No mortality occurred during the test.

The percentage of reactive treated animals was 0%.

The percentage of reactive control animals was 0%.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not a skin sensitiser based on the results of the test.
Executive summary:

Introduction

The potential of the test substance to induce skin sensitisation was assessed using the Magnusson and Kligman Maximisation Test according to OECD Guideline 406: Skin Sensitisation (17 July 1992).  

Method

Fifteen guinea-pigs (10 treated, 5 control) were used to assess the skin sensitisation potential of the test susstance. The effect was potentiated by the injection of Freund's Complete Adjuvant. The 10 treated animals were exposed to the test substance by intradermal injection at the concentration of 0.1 % with distilled water and epidermal application at the concentration of 80 % with distilled water. Concurrently, the 5 control animals received the vehicle (distilled water) only by intradermal and epidermal application.

Following a rest period of 10 to 14 days ending the induction period, all the animals were exposed to the non-irritant challenge dose of 80 % with distilled water. The extent and degree of skin reaction to the challenge exposure in the test animals were compared with those demonstrated by control animals.

Results

The percentage of animals that were sensitised was 0 out of 10 (0% sensitisation rate).  No reactions were observed in the five control animals (0% reaction rate).

Conclusion

The test item was found not to induce skin sensitisation and was therefore classified as negative for the potential to induce skin sensitisation.