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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
17. Nov to 18. Dec 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline stuidy; the tested substance is a precursor or Reactive Black 5 Bis-Vinyl and hydrolyses in aqueous solution from the bis-ester to the bis-vinyl form

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Reactive Black 5
IUPAC Name:
Reactive Black 5
Details on test material:
Preparation of Reaktiv Schwarz 5: Remazol Schwarz B flüssig 50

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 240 to 334 g
- Housing: group-housing (5/cage)
- Diet: ERKA Nr 8300 ad libitum
- Water: tap water ad libitum
- Acclimation period: ca. 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 17. Nov To: 18. Dec 1987

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Intradermal: 5%
dermal induction: 100%
dermal challenge: 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Intradermal: 5%
dermal induction: 100%
dermal challenge: 100%
No. of animals per dose:
Determination of primary not irritating concentration: 6
Determination of intradermal tolerability: 3
Sentinel group: 5
Control group: 5
Treatment group: 10
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100% challenge
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
blue staining of skin
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: blue staining of skin.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
blue staining of skin
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: blue staining of skin.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test item is not sensitizing in pirbright white guinea pigs.

Classification: not sensitizing