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Description of key information

The source substance is found to be skin sensitising in guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

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Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was not valid at time of test conduct
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production,4332 Stein / Switzerland
- Weight at study initiation: between 312 to 412 g
- Housing: The animal s 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 by individual ear tags
- Diet (e.g. ad libitum): ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG
- Water (e.g. ad libitum): ad libitum, fresh water
- Acclimation period: November 19, 1992

ENVIRONMENTAL CONDITIONS
- Temperature (°C):2 2+-3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
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 concentrations of test article have been prepared for intradermal injection: 5 % in physiological saline.
Since 5% FAT 41001/F in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
- 5% FAT 41001/F in physiological saline (w/v)
- 5% FAT 41001/F in the adjuvant/saline mixture (w/v)
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations have been examined on separate animals for the determination of the maximum sub irritant concentration :
10, 20, 30, and 50% in Vaseline.
The tested concentrations did not induce erythema reactions, therefore the following concentration was selected:
Epidermal induction
Concentration of test article: 50%
Vehicle: Vaseline
No skin irritation was observed in the pretest. Therefore the application site was pretreated with 10% sodium-lauryl sulfate (open application) 24 hours prior to the epidermal induction application.
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations have been examined on separate animals for the determination of the maximum sub irritant concentration: 10, 20, 30, and 50% in Vaseline.
The tested concentrations did not induce erythema reactions, therefore the following concentration was selected for epidermal challenge:
Concentration of test article: 50%
Vehicle: Vaseline

Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Test groups: 10 male and 10 female
Control groups: 5 males and 5 females
Details on study design:
Test procedure

Induction procedure (weeks 1 and 2):
The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later.
First induction week, intradermal injection
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article FAT 41001/F in physiological saline (w/v)
- test article FAT 41001/F in the adjuvant/saline mixture (w/v)
Second induction week, epidermal application
In the second week of induction FAT 41001/F was incorporated in Vaseline (w/w) and applied on a filter paper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g paste per patch; occluded administration for 48 hours).
Rest period
During weeks 3 and 4 no treatments were performed.
Challenge (week 5)
The animals were teste d on the flank with FAT 41001/F in Vaseline (w/w) and the vehicle alone (patch 2x2 cm; approx. 0.2 g paste per patch; occluded administration for 24 hours).
Control group
A control l group of 10 animals (5 m/5 f) was treated d 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 t article e to check the maximum sub irritant concentration of the test article e in adjuvant treated animals.
Positive control substance(s):
yes
Remarks:
potassium dichromate
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
18
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
1%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

None

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test substance is classified as skin sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.
Executive summary:

A sensitisation test in albino guinea pigs was performed to determine the contact allergenic potency of FAT 41001/F in albino guinea pigs . This test was based on the OECD Guideline No. 406, adopted May 12, 1981, adapted July 17, 1992, by the OECD council

100 and 90 % of the animals were sensitised by the test subsance under the experimental conditions employed.

According to the maximisation grading the test substance showed skin-sensitising (contact allergenic ) effects in albino guinea pigs .

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the source and the target substance have very similar physicochemical and (eco)toxicological properties because their chemical structures are nearly identical. An analogue approach has thus been employed. The target substance is the meta-isomer of the dye Reactive Blue 049, where the sulphonate group is bound at the meta-position of the aminobenzene moiety. The source chemical is the reaction mass of both the meta-isomer and the para-isomer of Reactive Blue 049.
The presence of sulphonate groups make both dyes highly water soluble and therefore less critical for human health and environmental issues. Based on their chemical similarity, similar properties are expected in both humans and the environment.

2. SOURCE AND TARGET CHEMICAL(S)
Source: Reactive Blue 49 meta/para (CAS# 72214-18-7 / EC# 276-481-8)
Target: Reactive Blue 49 meta (CAS# 72927-99-2 / EC# 277-040-2)

3. ANALOGUE APPROACH JUSTIFICATION
see attachment under 4.2 Melting point / freezing point
Reason / purpose:
read-across source
Justification for non-LLNA method:
Test was not valid at time of test conduct
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
18
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
1%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test substance is classified as skin sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.
Executive summary:

A sensitisation test in albino guinea pigs was performed to determine the contact allergenic potency of Reactive Blue 49 (meta/para) in albino guinea pigs . This test was based on the OECD Guideline No. 406, adopted May 12, 1981, adapted July 17, 1992, by the OECD council

100 and 90 % of the animals were sensitised by the test subsance under the experimental conditions employed.

According to the maximisation grading the test substance showed skin-sensitising (contact allergenic ) effects in albino guinea pigs .

The structurally related target substance will show the same behaviour and will therefore be classified as a skin sensitiser.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

A sensitization study was performed to determine the contact allergenic potency of the test substance in albino guinea pigs. This test was based on the OECD Guideline No. 406, adopted May 12, 1981, adapted July 17, 1992, by the OECD council.

In this study, 100 and 90 % of the animals showed positive skin reactions after 24 and 48 hours, respectively, under the experimental conditions employed. According to the maximisation grading the test substance showed skin-sensitising (contact allergenic) effects in albino guinea pigs .


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Reactive Blue 49 (meta/para) is found to be sensitising to skin in guinea pigs. The structurally related target substance will show the same behaviour and will therefore also be classified as a skin sensitiser.