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EC number: 231-842-9 | CAS number: 7758-89-6
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:
- other: This is a GLP study conducted in accordance with current guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
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:
- An LLNA study was not conducted because this method is prone to give false positive results for copper compounds and strong dermal irritants.
Test material
- Reference substance name:
- Copper chloride
- EC Number:
- 231-842-9
- EC Name:
- Copper chloride
- Cas Number:
- 7758-89-6
- Molecular formula:
- ClCu
- IUPAC Name:
- λ¹-copper(1+) chloride
- Details on test material:
- - Name of test material (as cited in study report): Cuprous chloride
- Substance type: Inorganic
- Physical state: Powder
- Analytical purity: 99.1%
- Lot/batch No.: 22006-01s
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories BV
- Age at study initiation: 4 - 5 weeks
- Weight at pretest initiation: 282 - 353 g
- Housing: Individually in Makrolon type-4 cages with standard softwood bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Four weeks for the test and contro groups of the main test. No acclimatisation for animals of the pre-test.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Concentration / amount:
- Intradermal induction: 1%
Epidermal induction: 10%
Epidermal challenge: 0.5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Concentration / amount:
- Intradermal induction: 1%
Epidermal induction: 10%
Epidermal challenge: 0.5%
- No. of animals per dose:
- 1 Intradermal Pretest (1): 1
2 Epidermal Pretest (1): 2
3 Control Group: 5
4 Test Group: 10
5 Intradermal Pretest (2): 1
6 Epidermal Pretest (2): 2 - Details on study design:
- RANGE FINDING TESTS:
Intradermal applications:
Four intradermal injections (0.1 ml/site) of a 1: 1 (v/v) mixture of Freund's Complete Adjuvant (FCA)/physiological saline were made into the shaved neck of one guinea pig. Six days later intradermal injections (0.1 ml/site) were made into the clipped flank of the same guinea pig at concentrations of 25%, 15% and 10% of the test item in PEG 300. Dermal reactions were assessed 24 and 48 hours later.
No concentration tolerated for intradermal exposure could be determined after the first intradermal pretest described above. Therefore, a second pretest was performed with one additional guinea pig, treated in the same way as those described previously. Six days later after four intradermal injections (0.1 ml/site) of a 1:1 (v/v) mixture of FCA/physiological saline into the shaved neck, intradermal injections (0.1 ml/site) were made into the clipped flank of the second guinea pig at concentrations of 5%, 1 % and 0.5% in PEG 300. Dermal reactions were assessed 24 hours later. Based on the results, the test item concentration of 1% was selected for intradermal induction in the main test.
Epidermal applications:
Four intradermal injections (0.1 ml/site) of a 1: 1 (v/v) mixture of FCA/physiological saline were made into the shaved neck of two guinea pigs. Six days later, four patches of filter paper (3 x 3 cm) were saturated with the test item at 75%, 50%, 25% and 15% in PEG 300 and applied to the shaved flanks of the same guinea pigs. The amount or volume of test item preparation applied was approximately 0.2 g at 75% and 0.2 ml at 50%, 25% and 15%. The occlusive dressings were left in place for 24 hours.
No highest non-irritating concentration could be determined after the epidermal pretest described above. Therefore, a second pretest was performed with two additional guinea pigs, treated in the same way as those described previously, with the concentrations of 10%, 5%, 1% and 0.5% in PEG 300, using an application volume of approximately 0.2 ml. For the second epidermal pretest, the reaction sites were assessed 24 and 48 hours after removal of the dressing for erythema and oedema. Based on the results the test item concentration selected for epidermal induction and challenge in the main test was 10% and 0.5%, respectively.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Injection / Performed on Test Day 1:
An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 mL/site) were made just within the boundaries of a 4 x 6 cm area in the clipped region as follows:
Test Group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test item at 1 % in PEG 300.
3) The test item at 1 % in a 1: 1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
Control group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) PEG 300.
3) 1: 1 (w/w) mixture of PEG 300 in a 1: 1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
Epidermal Induction / Performed on Test Day 8 :
One week after the intradermal injections, the scapular area (approximately 6 x 8 cm) was again shaved prior to epidermal induction. A 2 x 4 cm patch of filter paper was saturated with the test item at 10% in PEG 300 and placed over the injection sites of the test animals. The volume of test item preparation applied was approximately 0.3 ml. The patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The occlusive dressings were left in place for 48 hours. The epidermal application procedure described ensured intensive contact of the test item.
The guinea pigs of the control group were treated as described above with PEG 300 only, applied at a volume of approximately 0.3 ml.
The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema.
B. CHALLENGE EXPOSURE
The test and control guinea pigs were challenged two weeks after epidermal induction and treated in the same way.
Two patches (3 x 3 cm) of filter paper were saturated with the test item at the highest tested non¬irritating concentration of 0.5% (applied to the left flank) and the vehicle only (PEG 300 applied to the right flank) using the same method as for the epidermal application. The volume of test item preparation applied was approximately 0.2 ml and a volume of approximately 0.2 ml was used for the vehicle. The dressings were left in place for 24 hours. - Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYLCINNAMALDEHYDE
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Cuprous chloride, 0.5% in PEG 300
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Cuprous chloride, 0.5% in PEG 300. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: No clinical signs were observed..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Cuprous chloride, 0.5% in PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Cuprous chloride, 0.5% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs were observed..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: PEG 300. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs were observed..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: PEG 300. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs were observed..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Cuprous chloride, 0.5% in PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Cuprous chloride, 0.5% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No clinical signs were observed..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Cuprous chloride, 0.5% in PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Cuprous chloride, 0.5% in PEG 300. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No clinical signs were observed..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: PEG 300. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No clinical signs were observed..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: PEG 300. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No clinical signs were observed..
Any other information on results incl. tables
Viability / Mortality / Macroscopic Findings:
No intercurrent deaths occurred during the course of the study, hence no necropsies were performed.
Clinical Signs
No clinical signs were observed throughout the entire observation period.
Body Weights
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
Skin Reactions in the Intradermal Induction / Performed on Test Day 1:
Expected common findings were observed in the test and control groups after the different injections using FCA intradermally. These findings consisted of erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation.
Skin Reactions in the Epidermal Induction / Performed on Test Day 8:
Control Group
No erythematous or oedematous reaction was observed in the control animals treated with PEG 300 only.
Test Group
Discrete/patchy to moderate/confluent erythema was observed in all test animals at the 24-hour reading after treatment with the test item prepared at 10% in PEG 300. Discrete/patchy erythema was observed in 5/10 test animals at the 48 -hour reading. In addition, two of the five animals showed scaling at the local treated skin.
Skin Reactions in the Challenge / Performed on Test Day 22:
Control Group
No local skin reactions were observed in the control animals when treated with PEG 300 alone or when treated with the test item prepared at 0.5% in PEG 300.
Test Group
No local skin reactions were observed in the test animals when treated with PEG 300 alone. Discrete/patchy erythema were observed in 2/10test animals at the 24 -hour reading after treatment with the test item prepared at 0.5% in PEG 300.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the above mentioned findings in an adjuvant sensitisation test (M&K-test) in guinea pigs and in accordance to Regulation (EC) No 1272/2008, Cuprous Chloride does not have to be classified as a skin sensitizer.
- Executive summary:
In order to assess the cutaneous allergenic potential of Cuprous Chloride, a GLP Maximization- Test was performed in 15 (10 test and 5 control) female albino Dunkin Hartley guinea pigs, in accordance with OECD Guideline No. 406 and the Commission Regulation (EC) No 440/2008, B.6.
The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 1% dilution of the test item in PEG 300 and in an emulsion of FCA/physiological saline. The epidermal induction of sensitisation was conducted for 48 hours under occlusion with the test item at 10% in PEG 300 one week after the intradermal induction. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion.
Two weeks after epidermal induction the test and control animals were challenged by epidermal application of the test item at 0.5% in PEG 300 and PEG 300 alone under occlusive dressing.
No deaths occurred during the course of the study. No toxic signs were evident in the guinea pigs of the control or test group. 20% of the test animals showed skin reactions 24 hours after the challenge treatment with Cuprous Chloride at 0.5% (w/w) in PEG 300, but no skin reactions were observed 48 hours after treatment. No local skin effects were observed in any animals of the control group.
Based on the above mentioned findings in an adjuvant sensitisation test (M&K-test) in guinea pigs and in accordance to Regulation (EC) No1272/2008,Cuprous Chloride does not have to be classified as a skin sensitizer
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