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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only data summary seen from SNIF docs

Data source

Reference
Reference Type:
other: ECHA
Title:
Unnamed
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-amino-4-[2-methyl-5-(4-methylphenylsulfonylamino)phenylamino]anthraquinone-2-sulfonate
EC Number:
400-100-8
EC Name:
Sodium 1-amino-4-[2-methyl-5-(4-methylphenylsulfonylamino)phenylamino]anthraquinone-2-sulfonate
Cas Number:
84057-97-6
Molecular formula:
C28H22N3NaO7S2
IUPAC Name:
sodium 1-amino-4-[2-methyl-5-(4-methylphenylsulfonylamino)phenylamino]anthraquinone-2-sulfonate
Details on test material:
Not defined in record seen - SNIF

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
5% for injections
25% for topical challenges with material soaked onto paper
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
water
Concentration / amount:
5% for injections
25% for topical challenges with material soaked onto paper
No. of animals per dose:
10 male and 10 female
5 male and 5 female used as control

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other:
Group:
test chemical
Dose level:
25% challenge
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No adverse effects reported
Remarks on result:
other: Reading: other:. Group: test group. Dose level: 25% challenge. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse effects reported.

Any other information on results incl. tables

Very little detail provided in the NONS summary

Applicant's summary and conclusion

Conclusions:
Data obtained through ECHA Inquiry under the 12 year rule.
Executive summary:

other: not classified

Data obtained through ECHA Inquiry under the 12 year rule.