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Diss Factsheets

Administrative data

Description of key information

The test substance is considered as a skin sensitizer 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:
12 September 1994 to 2 December 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 (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
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:
Code number: FAT-20044/B
Batch-Nr.: 99
Appearance: solid
Solubility: 60 g/l [in water]
Storage: room temperature
Expiration date: 07/99
Species:
guinea pig
Strain:
Pirbright-Hartley
Remarks:
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
- Weight at study initiation:
348 to 424 g
- Housing:
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: standard guinea pig pellets - NAFAG No. 845, Gossau SG ad libitum
- Water: ad libitum
- Acclimation period:
5 day

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 % / 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:
10 %
Day(s)/duration:
Day 21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
5 male and 5 female
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 20044/B in physiological saline (w/v)
- 5 % FAT 20044/B 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 20044/B 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 20044/B in physiological saline
Control group:
- physiological saline only
DAY 21: Challenge
The test and control group animals were tested on one flank with FAT 20044/B 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:
- 10 % FAT 20044/B in physiological saline
- physiological saline only
Observations and records
Induction reactions
After removal of the dressing on day 10, irritation of the epidermal application site was observed in 10/10 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.
General
The body weight was recorded at start and end of the test.
Interpretation of results
The sensitizing potential of FAT 20044/B was classified according to the grading of Magnusson and Kligman. According to the guide to the labelling of dangerous substances and the criteria for the choice of sentences indicating particular hazards (R sentences) attributed to dangerous substances (Commission Directive 93/21/EEC, April 27, 1993) a test article was classified as a sensitiser in the case where a positive response was noted in at least 30 % of the animals.
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole puriss
Positive control results:
All animals treated with 2-Mercaptobenzothiazole puriss showed erythema and almost all showed edema after 24 and 48 h.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
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:
5
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
Erythema and edema
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
Erytema and edema
Remarks on result:
positive 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:
Edema and erythema
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
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

Body weights were not affected by treatment. Under the experimental conditions employed, 80% and 60% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. Therefore, FAT 20044/B is considered as a moderate skin sensitizer in albino guinea pigs.

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
FAT 20044/B is considered as a skin sensitizer in albino guinea pigs.
Executive summary:

Skin Sensitisation test with FAT 20044/B was carried out using Guinea Pig Maximisation Test according to OECD guideline 406. The test t was performed on 5 male and 5 female guinea pigs in the test group and 5 female guinea pigs in the control group.


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 20044/B in physiological saline (w/v)


- 5 % FAT 20044/B 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 20044/B 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 20044/B in physiological saline


 


Control group:


- physiological saline only


 


DAY 21: Challenge


The test and control group animals were tested on one flank with FAT 20044/B 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:


- 10 % FAT 20044/B in physiological saline


- physiological saline only


 


Observations and records


Induction reactions


After removal of the dressing on day 10, irritation of the epidermal application site was observed in 10/10 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 body weight was recorded at start and end of the test. In a pre-test, reactions were observed with 20, 30, and 50 % FAT 20044/B in physiological saline. In main test, body weights were not affected by treatment. Under the experimental conditions employed, 80 % and 60 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. Based on the study results, FAT 20044/B is considered as a moderate skin sensitizer in albino guinea pigs.

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

Skin Sensitisation test with FAT 20044/B was carried out using Guinea Pig Maximisation Test according to OECD guideline 406. The test was performed on 5 male and 5 female guinea pigs in the test group and 5 female guinea pigs in the control group. In a pre-test, reactions were observed with 20, 30, and 50 % FAT 20044/B in physiological saline. In main test, body weights were not affected by treatment. Under the experimental conditions employed, 80 % and 60 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. Based on the study results, FAT 20044/B is considered as a moderate skin sensitizer in albino guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the findings in the skin sensitisation study, the test substance should be classified as Skin Sensitiser 1B according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.