Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Copper is the ion which will be interesest in toxiocolgy matters. So here will be make a data waiving form copper hydroxide to copper hydroxide nitrate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study peromemd before LLNA was a valid guideline

Test material

Constituent 1
Chemical structure
Reference substance name:
Copper dihydroxide
EC Number:
243-815-9
EC Name:
Copper dihydroxide
Cas Number:
20427-59-2
Molecular formula:
CuH4O2
IUPAC Name:
copper(II) dihydroxide
Details on test material:
URA-08740-F-O-WP

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright withe
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
other: interdermal in water, 5 %
Vehicle:
petrolatum
Concentration / amount:
0.1 to 5%
Day(s)/duration:
-
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.1 to 5%
Day(s)/duration:
-
Adequacy of challenge:
not specified
No. of animals per dose:
20 test and 20 controll animals
Positive control substance(s):
yes
Remarks:
-

Results and discussion

Positive control results:
-

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: all
Hours after challenge:
24
Group:
test chemical
Dose level:
all
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
score: 0
Remarks on result:
other: Reading: other: all. . Hours after challenge: 24.0. Group: test group. Dose level: all. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: score: 0.
Key result
Reading:
other: all
Hours after challenge:
48
Group:
test chemical
Dose level:
all
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
score: 0
Remarks on result:
other: Reading: other: all. . Hours after challenge: 48.0. Group: test group. Dose level: all. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: score: 0.
Key result
Reading:
other: all
Hours after challenge:
24
Group:
negative control
Dose level:
all
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: other
Remarks:
all
Key result
Reading:
other: all
Hours after challenge:
48
Group:
negative control
Dose level:
all
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: other
Remarks:
all
Key result
Reading:
other: all
Hours after challenge:
24
Group:
positive control
Dose level:
all
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: other
Remarks:
all
Key result
Reading:
other: all
Hours after challenge:
48
Group:
positive control
Dose level:
all
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
no data
Remarks on result:
other: other
Remarks:
all

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
No skin reactions were observed. no sensization occured.