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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:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
OECD guidelines for LLNA not available at the time of testing

Test material

Constituent 1
Reference substance name:
Acid Black 52
IUPAC Name:
Acid Black 52
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Storage: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group,
respectively, initially weighing between 318 to 388 g.
The animals were housed i n d i v i d u a l l y in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags, kept at a constant room temperature of 22+3°C, at a r e l a t i v e humidity of 30 to 70% and a 12 hours light cycle day. The animals received ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG and fresh water.
All batches of the diet are assayed for n u t r i t i v e ingredients and contamination level by the manufacturer. Analytical results are available at the animal supply office. The drinking water quality fulfilled the critical parameters in the specifications of the "Schweizerisches Lebensmittelbuch"
(Edition 1972). The results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschütz) are available to CIBA-GEIGY Limited, as well as the results of inhouse chemical analysis by the analytical laboratories of the Pharmaceutical Division, CIBA-GEIGY Limited.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
Intradermal induction: 5% FAT40307/B in physiological saline (w/v)
5% FAT 40307/B in the adjjuvant/saline mixture (w/v)
Epidermal induction: 50% vaseline
Epidermal challenge: 30% vaseline

The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 40307/B have been examined on separate animals for the determination of the maximum subirritant concentration:
10, 20, 30, and 50% in vaseline.
Erythema reactions were observed with 50% FAT 40307/B in vaseline.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
Intradermal induction: 5% FAT40307/B in physiological saline (w/v)
5% FAT 40307/B in the adjjuvant/saline mixture (w/v)
Epidermal induction: 50% vaseline
Epidermal challenge: 30% vaseline

The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 40307/B have been examined on separate animals for the determination of the maximum subirritant concentration:
10, 20, 30, and 50% in vaseline.
Erythema reactions were observed with 50% FAT 40307/B in vaseline.
No. of animals per dose:
10 male and 10 female in the test group
5 male and 5 female in the control
Details on study design:
2.5. Auxiliary compounds
- Physiological saline (0.9 %), s t e r i l e solution (Hausmann, St. Gallen, Switzerland)
- Bacto Adjuvant, Complete, Freund (Difco Lab. Detroit, Michigan USA)
- Vaseline (white petrolatum) Ph, Zofingen, Switzerland)
Challenge controls:
A control group of 10 animals (5 m/5 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals.
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30%
No. with + reactions:
2
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
30%
No. with + reactions:
1
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1%
No. with + reactions:
9
Total no. in group:
10

Any other information on results incl. tables

The negative controlled was induced only with vehicle and challenged both with vehicle and the test article at the same concentration of the tes group

Applicant's summary and conclusion

Interpretation of results:
other: not classified unde Regulation 1272/2008
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for skin sensitisation following OECD 406-Guinea Pig Maximisation Test. Under the experimental conditions the substance is not considered as skin sensitizer.
Executive summary:

The substance was tested for skin sensitisation following OECD 406-Guinea Pig Maximisation Test.The induction was performed intradermal and epicutaneous with the help of an adjuvant at the dose of 50% in vaseline. Challenge was performed by occlusive epidermal application of a 30% concentration of the substance in vaseline. 10 females and 10 males were used as test group while 5 females and 5 males as control group. Challenge reactions were determined by scoring erythema and edema after 24 and 48 hours removal of the dressing. 10% and 5% of the animals showed positive response after 24 and 48h showing no potential to be a skin sensitizer.