Registration Dossier

Administrative data

Description of key information

Acid Violet 109 was assessed for the skin sensitisation potential in couple studies.FAT 21016/C was investigated in the albino guinea-pigs according to OECD TG 406 (GPMT method) and EU Method B. 6. Based on the results of the pre-test, the test group was exposed to following concentrations during the different phases of the study: intradermal induction: 5 % in Oleum arachidis, epidermal induction: 50 % in vaseline and challenge: 5 % in vaseline on one flank and vaseline only on the other flank. None of the animals of the test group showed skin reactions 24 and 48 hours after challenge exposure. Hence it was concluded that,FAT 21016/C did not show skin sensitising (contact allergenic) potential in albino guinea pigs.

FAT 20200/B was also assessed in a study conducted according to OECD Guideline 406 using Guinea pig maximisation technique. No animals from the test group showed any hypersensitivity after challenge exposure. hence, FAT 20200/B is also concluded as not being a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
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: 400047.32
- Expiration date of the lot/batch: December, 1998

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: between 317 to 408 g
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Diet : standard guinea pig pellets - NAFAG No. 845, Gossau SG, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Route:
intradermal
Vehicle:
other: Oleum arachidis
Concentration / amount:
5 %
Day(s)/duration:
Day 0
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Remarks:
Vaseline
Concentration / amount:
50 %
Day(s)/duration:
Day 8
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Remarks:
(vaseline)
Concentration / amount:
5 %
Day(s)/duration:
Day 21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Test Group: 10/sex

Control group:
10 animals of same sex
Details on study design:
RANGE FINDING TESTS:
Intradermal Induction:
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest. The following concentration of test article has been used for intradermal injection:
5 % in Oleum arachidis (w/v).
Since 5 % FAT 21016/C in Oleum arachidis could be injected and was well tolerated, this concentration was used for the intradermal induction.

Epidermal Applications (induction and challenge)
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 21016/C have been examined on separate animals for the determination of the maximum subirritant concentration (see also Table 4):
1, 5, 10, 20, 30, and 50 % in vaseline.
50 % was the highest possible concentration of the test article in vaseline.
Reactions were observed with 10, 20, 30, and 50 % FAT 21016/C in vaseline.

MAIN STUDY
A. INDUCTION EXPOSURE
DAY 0: INDUCTION, intradermal injections:
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % FAT 21016/C in Oleum arachidis (w/v)
- 5 % FAT 21016/C in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- Oleum arachidis

DAY 8: INDUCTION, epidermal application
In the test group FAT 21016/C was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours).
The control group was treated with the vehicle only.
Test group:
- 50 % FAT 21016/C in vaseline
Control group:
- vaseline only

B. CHALLENGE EXPOSURE
- Exposure period: 24 hrs
- Test groups: The test group animals were tested on one flank with FAT 21016/C in vaseline (w/w) and on the other flank with the vehicle alone
- Control group: The control group animals were tested on one flank with FAT 21016/C in vaseline (w/w) and on the other flank with the vehicle alone
- Site: flank
- Concentrations: 0.2 g per patch
- Evaluation (hr after challenge): 24 h
Positive control substance(s):
yes
Remarks:
mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.
Positive control results:
Positive control groups showed weak sensitisation potential
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
intradermal induction: 5 %; epidermal induction: 50 % and challenge: 5 %
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:
test group
Dose level:
intradermal induction: 5 %; epidermal induction: 50 % and challenge: 5 %
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:
negative control
Dose level:
intradermal induction: 0 %; epidermal induction: 0 % and challenge: 5 % FAT 21016/C and vehicle on separate flanks
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
intradermal induction: 0 %; epidermal induction: 0 % and challenge: 5 % FAT 21016/C and vehicle on separate flanks
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
intradermal induction: 5 %; epidermal induction: 50 % and challenge: 30 %
No. with + reactions:
12
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
intradermal induction: 5 %; epidermal induction: 50 % and challenge: 30 %
No. with + reactions:
13
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation

Induction reactions:

After removal of the dressing on day 10, irritation of the epidermal application site was observed in 20/20 test group animals.

Challenge reactions:

Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. The challenge reactions showed 0 score for erythma and edema.

General

The body weight was recorded at start and end of the test. Body weights were not affected by treatment.

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 21016/C did not show skin sensitising potential in albino guinea pigs.
Executive summary:

Evaluation of the skin sensitisation potential of FAT 21016/C was performed in the albino guinea-pigs according to OECD TG 406 (GPMT method) and EU Method B. 6, using maximisation technique. Based on the results of the pre-test, the test group was exposed to following concentrations during the different phases of the study: intradermal induction: 5 % in Oleum arachidis, epidermal induction: 50 % in vaseline and challenge: 5 % in vaseline on one flank and vaseline only on the other flank. None of the animals of the test group showed skin reactions 24 and 48 hours after challenge exposure. Hence it was concluded that, FAT 21016/C did not show skin sensitising (contact allergenic) potential in albino guinea pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the findings in the skin sensitisation studies, Acid Violet 109 should be classified as non-sensitiser according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.