Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

The skin sensitisation potential of FAT 40278/A (Disperse Blue 077 content: 45 %) has been investigated in a study conducted using Magnusson and Kligman maximation method as described in OECD Guideline 406. In this study, a group of guinea pigs containing 10 males and 10 females, received FAT 40278/A at 1 % concentration in the intradermal induction phase and at 10 % concentration during the epidermal induction phase. The day before epidermal induction, the application sites were pretreated with 10 % sodium lauryl sulfate as open application. Two weeks after the epidermal induction application the animals were challenged with the occluded epidermal application for 24 h on the flank with FAT 40278/A (concentration 3 %) in vaseline and the vehicle alone. 95 % of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings. Hence, FAT 40278/A was considered to be a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted May 12, 1986
Deviations:
yes
Remarks:
Positive control not reported
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN 37761.62
- Expiration date of the lot/batch: October 1991

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility of the test substance in the solvent/vehicle: 1g/l water
Species:
guinea pig
Strain:
Pirbright-Hartley
Remarks:
Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
Test System
The albino guinea pig is the recommended species for skin sensitization studies.
- Animal strain: Pirbright White Strain (Tif: DHP)
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Date of acclimatization: January 5, 1987

Husbandry
- The test was performed on 10 male and 10 female guinea pigs per group weighing between 334 to 417 g (approx. 10 weeks old).
- The animals were housed individually in Macrolon cages (Type 3), assigned to the different groups by means of random numbers generated by the random number generator, identified with individual ear tags, kept at a constant room temperature of 22±3°C, at a relative humidity of 30 to 70 % and a 12 h light cycle day.
- The animals received ad libitum standard guinea pig pellets - NAFAG No.847, Gossau SG and fresh water.
- All batches of the diet are assayed for nutritive ingredients and contamination level by the manufacturer. Analytical results are available at the animal supply office.
- The drinking water is examined periodically by the IWB (Industrielle Werke Basel), results are available to CIBA-GEIGY Ltd.
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1 ml per injection
- adjuvant and saline (1:1)
- 1% test compound FAT 40278/A in physiological saline
- 1% test compound FAT 40278/A in the adjuvant saline mixture
Day(s)/duration:
At the start
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
0.4 g paste of 10 % FAT 40278/A in vaseline
Day(s)/duration:
one week after intradermal induction
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
approx. 0.2 g paste of 3 % FAT 40278/A in vaseline
Day(s)/duration:
Two weeks after the epidermal induction
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 males and 10 females per group
Details on study design:
RANGE FINDING TESTS:
The concentration of the test compound for the induction and challenge periods were determined on separate animals.

MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal induction)
- No. of exposures: 1
- Test groups: 1
- Control group: 1
- Site: shaved neck
- Frequency of applications: once
- Concentrations: 1%

B. INDUCTION EXPOSURE (Epidermal induction)
- No. of exposures: 1
- Test groups: 1
- Control group: 1
- Site: neck of the animals
- Frequency of applications: once
- Duration of exposure: 48 h
- Concentrations: 10% (with prior application of SDS 10%)

C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after epidermal induction
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: flank
- Concentrations: 3%
- Evaluation (hr after challenge): 24 h after removing the dressing
Positive control substance(s):
not specified
Positive control results:
None
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Intradermal induction: 1 %, Epidermal induction: 10 %, challenge: 3 %
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
clinical observations not specified
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Intradermal induction: 1 %, Epidermal induction: 10 %, challenge: 3 %
No. with + reactions:
19
Total no. in group:
20
Clinical observations:
clinical observations not specified
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Under the experimental conditions employed, 95 % of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings.

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
FAT 40278/A was considered to be a skin sensitiser.
Executive summary:

The skin sensitisation potential of FAT 40278/A (Disperse Blue 077 content: 45 %) has been investigated in a study conducted using Magnusson and Kligman maximation method as described in OECD Guideline 406. In this study, a group of guinea pigs containing 10 males and 10 females, received FAT 40278/A at 1 % concentration in the intradermal induction phase and at 10 % concentration during the epidermal induction phase. The day before epidermal induction, the application sites were pretreated with 10 % sodium lauryl sulfate as open application. Two weeks after the epidermal induction application the animals were challenged with the occluded epidermal application for 24 h on the flank with FAT 40278/A (concentration 3 %) in vaseline and the vehicle alone. 95 % of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings. Hence, FAT 40278/A was considered to be a skin sensitiser.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the findings in the skin sensitisation study, Disperse Blue 077 is to be classified as Skin Sensitiser 1A according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.