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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted in compliance with GLP standards according to Guideline 84/449/EWG, B.6 and OECD 406 (1981). However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 84/449/EG, B.6, OECD Guideline 406 (1981)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
EC Number:
403-530-4
EC Name:
Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
Cas Number:
129423-54-7
Molecular formula:
C17H13CaClN4O7S2
IUPAC Name:
calcium 4-chloro-5-methyl-2-{2-[3-methyl-5-oxo-1-(3-sulfonatophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazen-1-yl}benzene-1-sulfonate

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White Hoe: DHPK (SPF Lac)

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
i.c.: 1% in 50 % FCA Paraffin
p.c.: 25% in Vaseline

Concentration of test material and vehicle used for each challenge:
p.c.: 25% in Vaseline
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
i.c.: 1% in 50 % FCA Paraffin
p.c.: 25% in Vaseline

Concentration of test material and vehicle used for each challenge:
p.c.: 25% in Vaseline
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:
25 %
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: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The study was carried out in compliance with GLP according to guideline 84/449/EG, B.6 and OECD 406. The substance is non-sensitizing in nature.
Executive summary:

The sensitisation potential of the test substance was investigated in a guinea pig maximisation study. 10 animals were induced with test material, 5 animals with vehicle. There were no signs of toxicity observed in any animal. No sensitization was observed in animals in this study. The result of this study is used as a key value for hazard assessment and classification and labelling.