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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
August 12, 1992 - December 17, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
EC Number:
254-879-2
EC Name:
3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
Cas Number:
40306-75-0
Molecular formula:
C8H10N2O5S
IUPAC Name:
3-acetamido-5-amino-4-hydroxybenzenesulfonic acid
Specific details on test material used for the study:
Test article: FAT 92333/A
Batch No.: K37 19.5.92
Contents of active ingredients: 97.2%
Physical properties: solid
Storage conditions: room temperature
Validity: June 1, 1993
Test article received: June 25, 1992

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. H. VI (Siegfried AG, Zofingen, Switzerland)







In vivo test system

Test animals

Species:
guinea pig
Strain:
other: 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 sensitisation studies.
Animal strain: Pirbright White Strain (Tif: DHP)
Breeder: CIBA-GEIGY Limited
Animal Production
4332 Stein / Switzerland
Date of acclimatisation: August 19, 1992

Group Size and Husbandry
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 300 to 392 g. 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 by individual ear tags, kept at a constant room temperature of 2 2+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 nutritive 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 Gewaesserschutz) 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.

Sensitivity of strain
The sensitivity of the strain is checked once or twice per year with a known sensitiser, such as mercaptobenzothiazole, benzocaine, or potassium-dichromate.

Study design: in vivo (non-LLNA)

No. of animals per dose:
10
Details on study design:
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 92333/A in physiological saline (w/v)
- test article FAT 92333/A in the adjuvant /saline mixture (w/v)

Second induction week, epidermal application
In the second week of induction FAT 92333/A 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 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 tested on the flank with FAT 92333/A 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 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.

Concent rat ions
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 concentrations of test article have been prepared for intradermal injection:
5 % in physiological saline.
Since 5% FAT 92333/A in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
- 5 % FAT 92333/A in physiological saline (w/v)
- 5 % FAT 92333/A in the adjuvant/saline mixture (w/v)

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 92333/A have been examined on separate animals for the determination of the maximum subirritant 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-laurylsulfate (open application) 24 hours prior to the epidermal induction application.

Epidermal challenge
Concentration of test article: 50 %
Vehicle: vaseline

Observations and records
Induction reactions
After the intradermal and the epidermal induction application irritant reactions are normally induced by the adjuvant, the high test article concentration, or the sodium lauryl sulfate pretreatment. Because most of the reactions are treatment related and not compound related, the reactions are only described in special cases in the section of results.

Challenge reactions
Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.

General
The sensitising potential of FAT 92333/A was classified according to the grading of Magnusson and Kligman. The body weight was recorded at start and end of the test.
Challenge controls:
Yes
Positive control substance(s):
yes
Remarks:
Potassiumdichromate

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Under the experimental conditions employed, 95 and 90 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. FAT 92333/A is, therefore, classified as an extreme sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
95 % and 90 % of the animals were sensitised by FAT 92333/A under the experimental conditions employed. According to the maximisation grading FAT 92333/A showed an extreme grade of skin-sensitising (contact allergenic) potential in albino guinea pigs.
Executive summary:

The substance showed skin-sensitising (contact allergenic)