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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
unknow
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium sodium (4-((5-chloro-2-hydroxyphenyl)azo)-2,4-dihydro-5-methyl-3H-pyrazol-3-onato(2-))(3-((4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl)azo)-4-hydroxy-5-nitrobenzenesulfonato(3-)) chromate(2-)
EC Number:
414-250-7
EC Name:
Lithium sodium (4-((5-chloro-2-hydroxyphenyl)azo)-2,4-dihydro-5-methyl-3H-pyrazol-3-onato(2-))(3-((4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl)azo)-4-hydroxy-5-nitrobenzenesulfonato(3-)) chromate(2-)
Cas Number:
149564-66-9
Molecular formula:
C27H19ClCrLiN9NaO9S

In vivo test system

Test animals

Strain:
other: guinea pig/ strain Bor: DHPW
Sex:
not specified
Details on test animals and environmental conditions:
Not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: Not specified
Vehicle:
not specified
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal: 1 %
b) Topic: 10 %
Day(s)/duration:
Concentration of test material and vehicle used at induction:
a) Intradermal: 1 %
b) Topic: 10 %
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: Not specified
Vehicle:
not specified
Concentration / amount:
Concentration of test material and vehicle used for each challenge:
a) 1. topic : 6 %
b) 2. topic : 3 %
Day(s)/duration:
Not specified
Adequacy of challenge:
not specified
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Details on study design:
Not specified
Challenge controls:
Not specified
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not specified

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
6%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
3%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 6 %
Signs of irritation during induction:
None
Evidence of sensitisation of each challenge concentration:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not classified as skin sensitizer.