Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 study was carried out in accordance with internationally valid GLP principles.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.6 ( Meerschweinchen-Maximierungstest (GPMT)( OECD 406
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Iron (III) tris(4-methylbenzenesulfonate)
EC Number:
420-960-8
EC Name:
Iron (III) tris(4-methylbenzenesulfonate)
Cas Number:
77214-82-5
Molecular formula:
C21H21FeO9S3
IUPAC Name:
iron(3+) tris(4-methylbenzene-1-sulfonate)

In vivo test system

Test animals

Species:
other: guinea pig, Albino Stamm: Hsd POC: DH, SPF-Zucht

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentartion of test material and vehicle used at induction:
a) intradermale induction: 2,5% w/w in physiolog. NaCl
b) topic: 25% in physiolog. NaCl
Concentration of test material and vehicle used for each challenge:
a) topic: 12 % in physiol: Kochsalzlsg. (0,5 ml)
Challenge
Concentration / amount:
Concentartion of test material and vehicle used at induction:
a) intradermale induction: 2,5% w/w in physiolog. NaCl
b) topic: 25% in physiolog. NaCl
Concentration of test material and vehicle used for each challenge:
a) topic: 12 % in physiol: Kochsalzlsg. (0,5 ml)
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
12%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 12%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Signs of irritation during induction: none

Evidence of sensitisation of each challenge concentration: none

Other observation:

In the case of provocation tests, no skin reactions were observed.

Appearance, behavior and body weight development of animals in the test groups the same as in the control.

Applicant's summary and conclusion

Interpretation of results:
other: not classified