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Description of key information

The skin sensitization potential of FAT 20290/B was evaluated in a study conducted according to OECD Guideline 406. The Guinea pigs tested included 10 (5 males and 5 females) animals in control group, 20 (10 males and 10 females) in the test group. The test group received following test concentrations: intradermal induction: 5 %, epidermal induction 50 %, epidermal challenge 10 %.

Under the experimental conditions employed, 15 % and 20 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. Hence, it can be concluded that FAT 20290/B 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:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in May 12, 1981
Deviations:
no
Principles of method if other than guideline:
None
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.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.
Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 316-417 g
- Housing: Housed individually in Macrolon cages (Type 3)
- Diet: Standard guinea pig pellets- NAFAG No. 845, Gossau SG, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: 1 week


SENSITIVITY OF STRAIN
- The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole,
hexyl cinnamic aldehyde or potassiumdichromate

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 30-70 %
- Photoperiod: 12 h light/12 h dark
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5 %
Day(s)/duration:
Day 0
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
50 %
Day(s)/duration:
Day 8
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
10 %
Day(s)/duration:
Day 21
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Main test: 10 control animals and 20 treated animals (10 males and 10 females).
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
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, intradermal injection: Three pairs of intradermal injections (0.1 mL per injection) were made simultaneously into the shaved neck of the animals as follows:
- adjuvant and saline (1:1)
- test substance in physiological saline
- test substance in the adjuvant/saline mixture

- Second induction, epidermal application: One week later test substance was incorporated in vaseline and applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm2; occluded administration for 48 h).
Dose of application: Approximately 0.4 g paste of 50 % test substance in vaseline.

B. CHALLENGE EXPOSURE
Two weeks after the epidermal induction application the animals were tested on the flank with test substance in vaseline and the vehicle alone (patch 2 x 2 cm²; occluded administration for 24 h).
Dose of application: Approximately 0.2 g paste of 10 % test substance in vaseline
The concentrations of the test substance for the induction and challenge periods were determined on separate animals.
Control group: A control group 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 substance (at least 10 animals) to control the maximum subirritant concentration of the test substance in adjuvant treated animals.


OBSERVATIONS:
Induction reactions
After the intradermal and the epidermal induction application irritant reactions are normally induced by the adjuvant and the high test article concentration. 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 body weight was recorded at start and end of the test.
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole puriss
Positive control results:
Not available
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Inradermal induction: 5 %, Epidermal induction 50 %, Epidermal challenge 10 %
No. with + reactions:
3
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Inradermal induction: 5 %, Epidermal induction 50 %, Epidermal challenge 10 %
No. with + reactions:
4
Total no. in group:
20
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:
2-Mercaptobenzothiazole puriss- Inradermal induction: 5 %, Epidermal induction 50 %, Epidermal challenge 30 %
No. with + reactions:
20
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
2-Mercaptobenzothiazole puriss- Inradermal induction: 5 %, Epidermal induction 50 %, Epidermal challenge 30 %
No. with + reactions:
20
Total no. in group:
20

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20290/B did not show a skin sensitizing (contact allergenic) potential in albino guinea pigs.
Executive summary:

The skin sensitisation potential of FAT 20290/B was evaluated in a study conducted according to OECD Guideline 406. The Guinea pigs tested included 10 (5 males and 5 females) animals in control group, 20 (10 males and 10 females) in the test group. The test group received following test concentrations: intradermal induction: 5 %, epidermal induction 50 %, epidermal challenge 10 %.

Under the experimental conditions employed, 15% and 20% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively. Hence, it can be concluded that FAT 20290/B did not show a skin sensitizing (contact allergenic) potential in albino guinea pigs.

 

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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