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Diss Factsheets

Administrative data

Description of key information

FAT 21095/C was found to be sensitizer to skin (contact allergenic) 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:
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
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
92/69/EEC, B.6.
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:
Test article: FAT 21095/C
Batch No.: 34
Additional specification: Lanacron Brown S-BRL crude moist lab dried
Contents/ Purity: ca.80 %
Physical properties: solid
Storage conditions: room temperature
Validity: July, 1999
Test article received: April 13, 1994
Species:
guinea pig
Strain:
other: Pirbright White strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: CIBA-GEIGY Limited, Animal Production 4332 Stein / Switzerland
- Housing: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.
- Diet (e.g. ad libitum):The animals received ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG.
- Water (e.g. ad libitum):fresh water ad libitum.
- Acclimation date: August 17, 1994.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5%
Day(s)/duration:
0
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
50%
Day(s)/duration:
8
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
1%
Day(s)/duration:
21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
5 per sex for the test group and 5 of one sex for controls.
After the challenge procedure, it was not possible to conclude if the test substance is a sensitiser or not and therefore testing in additional animals was performed to give a toal of 20 test and 10 control animals.
Details on study design:
Test procedure and concentrations used.

PRETEST
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 physiological saline (w/v). Since 5 % FAT 21095/C in physiological saline 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 21095/C have been examined on separate animals for the determination of the maximum subirritant concentration. 1, 5, 10, 20, 30, and 50% in physiological saline. 50 % was the highest possible concentration of the test article in physiological saline.

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 21095/C in physiological saline (w/v)
- 5 % FAT 21095/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
In the test group FAT 21095/C was incorporated in physiological saline 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 21095/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 21095/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).

Test and control group:
- 1 % FAT 21095/C in physiological saline
- physiological saline only
Challenge controls:
Challenge
The test and control group animals were tested on one flank with FAT 21095/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).
Test and control group:
- 1 % FAT 21095/C in physiological saline
- physiological saline only
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole puriss.
Positive control results:
In test group, 20/20animals were affected after 24 hours and 48 hours.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Intradermal induction - 5 %, Epicutaneous induction - 50 % and Epicutaneous challenge - 1 %
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Intradermal induction - 5 %, Epicutaneous induction - 50 % and Epicutaneous challenge - 1 %
No. with + reactions:
8
Total no. in group:
20
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:
10
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:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Intradermal induction - 5% in olive oil, Epidermal induction - 50% in vaseline, Epidermal challenge - 30% in vaseline.
No. with + reactions:
20
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% in olive oil, Epidermal induction - 50% in vaseline, Epidermal challenge - 30% in vaseline.
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
According to the EEC classification criteria (Commission Directive 93/21/EEC, April 27, 1993) FAT 21095/C did show skin-sensitising (contact allergenic) potential in albino guinea pigs.
Executive summary:

A GLP-compliant study was performed to determine the skin sensitisation potential of FAT 21095/C according to the OECD Guideline No. 406, adopted May 12, 1981, adapted July 17, 1992, by the OECD council, and on Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992). A total of 20 test and 10 control animals (guinea pigs) were used to perform the experiment. Based on the findings of the pretest, 5 % and 50 % of FAT 21095/C was used as intradermal (Day 0) and epidermal induction (Day 8) respectively. 1 % of FAT 21095/C in physiological saline was used for challenge. Under the experimental conditions employed, 35 % and 40 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. FAT 21095/C is, therefore, classified as a moderate sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman. According to CLP-criteria a test article is classified as a sensitiser in the case where a positive response is noted in at least 30 % of the animals. Hence, according to the CLP-Regulation FAT 21095/C was found to be sensitizer to skin (contact allergenic) in albino guinea pigs.

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

A GLP-compliant key study was performed to determine the skin sensitisation potential of FAT 21095/C according to the OECD Guideline No. 406, adopted May 12, 1981, adapted July 17, 1992, by the OECD council, and on Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992). A total of 20 test and 10 control animals (guinea pigs) were used to perform the experiment. Based on the findings of the pretest, 5 % and 50 % of FAT 21095/C was used as intradermal (Day 0) and epidermal induction (Day 8) respectively. 1 % of FAT 21095/C in physiological saline was used for challenge. Under the experimental conditions employed, 35 % and 40 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. FAT 21095/C is, therefore, classified as a moderate sensitiser in albino guinea pigs according to the grading of Magnusson and Kligman. Hence, according to the CLP classification criteria FAT 21095/C was found to be sensitizer to skin (contact allergenic) in albino guinea pigs.



Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the GHS classification criteria FAT 20077/C did show a skin-sensitising (contact allergenic) potential in albino guinea pigs.