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Diss Factsheets

Administrative data

Description of key information

The test substance did not show a skin - sensitizing (contact allergenic) potential in albino guinea pigs.

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:
31 January 1994 - 17 May 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (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.

Reason for selection
The maximisation test has been selected , because i t is one of the recommended tests in th e OECD guidelin e 406, adopted May 12, 1981, adapted July 17, 1992, a s well a s in Annex V, Part B
of Council Directiv e 67/548/EEC (Commission Directive 92/69/EEC of Jul y 31, 1992), and because the sensitivit y of the method is well known. The test has been performed in essence according to the origina l protoco l of Magnusson and Kligman (J. invest .Dermatol. 52, 268-276, 1969; Contac t Dermatitis 6, 46-50,1980).
Specific details on test material used for the study:
Code number: FAT - 20'035/C
EN-Nr.: 140200.31
Appearance: solid
Solubility: 20g/l [in water]
Storage: room temperature
Expiration date: 10/98
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:310 to 449 g.
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Diet: ad libitum standard guinea pig pellets -NAFAG No. 845, Gossau SG
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%):30 to 70
- Photoperiod (hrs dark / hrs light): a 12 hours light cycle day.
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5 % / 0.1 ml
Day(s)/duration:
Day 0
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
50 % / patch 2x4 cm; approx. 0.4 g per patch
Day(s)/duration:
Day 8
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
30 % / patch 2x2 cm; approx. 0.2 g per patch
Day(s)/duration:
Day 21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
5 per sex
Details on study design:
Test procedure:

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 20035/C in physiological saline (w/v)
- 5 % FAT 20035/C in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline

DAY 8: INDUCTION, epidermal application
The application site of all animals was pretreated with 10 % sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application.
In the test group FAT 20035/C was incorporated in physiological saline and applied on a filter paper 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 20035/C in physiological saline
Control group:
- physiological saline only

DAY 21: Challenge
The test and control group animals were tested on one flank with FAT 20035/C in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 2 4 hours).
Test and control group:
- 30 % FAT 20035/C in physiological saline
- physiological saline only
Challenge controls:
The test and control group animals were tested on one flank with FAT 20035/C in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 2 4 hours).
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole puriss
Positive control results:
None
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
30 %
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 chemical
Dose level:
30 %
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:
test chemical
Dose level:
50 %
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 chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Erythema in one animal
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
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:
0 %
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:
30 %
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
Erythema and edema
Remarks on result:
positive indication of skin sensitisation
Remarks:
2-Mercaptobenzothiazole puriss
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Erythema and edema
Remarks on result:
positive indication of skin sensitisation
Remarks:
2-Mercaptobenzothiazole puriss
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20035/C did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.
Executive summary:

A GLP-compliant study was performed to detect the sensitisation potential of FAT 20035/C in the guinea pig maximisation test, by following the OECD Guideline No. 406, adopted May 12, 1981 and on Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992). During induction phase on zero day test substance was delivered by 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. On day 8 of induction epidermal application of the test substance was done. In the test group FAT 20035/C was incorporated in physiological saline and applied on a filter-paper 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. And in the Challenge phase the test and control group animals were tested on one flank with FAT 20035/C in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).


No animal of the test group was sensitised by FAT 20035/C under the experimental condition employed. FAT 20035/C did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.

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

A key study was performed in compliance with GLP guidelines according to the OECD Guideline No. 406. During induction phase on zero day test substance was delivered by intradermal injections. On day 8 of induction epidermal application of the test substance was done, and in the Challenge phase the test and control group animals were tested on one flank with FAT 20035/C in physiological saline and on the other flank with the vehicle alone. No animal of the test group was sensitised by FAT 20035/C under the experimental conditions employed. According to the EEC classification criteria (Commission Directive 93/21/EEC, April 27, 1993) FAT 20035/C did not show a skin - sensitizing (contact allergenic) potential in albino guinea pigs.


In a supporting study, which was performed as per the method recommended in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO), demonstrated no difference between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis. Hence, at 30 % epidermal application there was no sensitising potential considered with FAT 20035/B. 


Another supporting study showed twenty percent of the animals were sensitized by FAT 20'035/B (purity: not known) under the experimental conditions employed. According to the maximization grading FAT 20035/B showed a mild skin-sensitizing (contact allergenic) potential in albino guinea pigs.


Considering the results from all the three studies it can be concluded that FAT 20035 is non-sensitising.



Migrated from Short description of key information:
FAT 20035/C did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.

Justification for selection of skin sensitisation endpoint:
GLP guideline study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the finding of the skin sensitisation study, the test substance does not need to be classified according EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.