Registration Dossier

Administrative data

Description of key information

FAT 40554 is considered to be a non sensitizer.

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:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
None
Reference:
Composition 1
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Principles of method if other than guideline:
None
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
None
Test material information:
Composition 1
Specific details on test material used for the study:
None
Details on study design:
None
Details on study design:
None
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles river, Japan- Weight at study initiation: 306 - 420 g- Housing:aluminium cages- Diet (e.g. ad libitum): (GC-4, oriental Yeast Co.) ad libitum- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: 12 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 24 +- 2°C- Humidity (%): 55+-15%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
Concentration of test material and vehicle used at induction: a) 0,5 g of the test substance was added to small amounts of corn oil.Concentration of test material and vehicle used for each challenge: a) 0,5 g of the test substance was added to small amounts of corn oil
Route:
epicutaneous, occlusive
Vehicle:
maize oil
Concentration / amount:
Concentration of test material and vehicle used at induction: a) 0,5 g of the test substance was added to small amounts of corn oil.Concentration of test material and vehicle used for each challenge: a) 0,5 g of the test substance was added to small amounts of corn oil
No. of animals per dose:
Number of animals in test group: 10Number of animals in negative control group: 10
Details on study design:
None
Challenge controls:
0.5% DNCB in acetone- control animals were treated with acetone similarly
Positive control substance(s):
yes
Remarks:
2,4 -dinitrochlorobenzene.
Positive control results:
None
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Cellular proliferation data / Observations:
None

No skin reactions were observed in any D-523 treated animals during the induction period. 24 and 48 hours after the challenge application with D-523, any skin reactions were observed neither in the sensitised animals with D-523 nor in the D-523 control animals.

In the DNCB sensitised group, slight to moderate erythema and slight sweeling were observed in all animals after the second induction. Moderate erythema and slight to moderate swelling were observed in all animals after the third induction. 24 hours after the challenge application with DNCB, slight to moderate erythema and slight swelling were observed in all animals. Slight erythema was observed in all animals and slight swelling was observed in 3 animals 48 hours after challenge. No skin reactions were observed in the DNCB control group 24 and 48 hours after the challenge with DNCB. Thus, it was shown that DNCB was a definite skin sensitizer and that the test systems worked properly.

From the results, it was concluded that D-523 is not a skin sensitiser.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance FAT 40554 is non sensitiser in animals.
Executive summary:

A study was performed to determine the skin sensitisation potential of FAT 40554 in guinea pigs according to EU Method B.6 (Skin Sensitisation). Skin sensitisation test with D-523 was conducted in male guinea pigs by using Buehler's method.

A dose of 0.5g of the test material was topically applied for induction to the flank of each animal with a lint patch once a week, 3 times in total with the time interval of 1 week. 2 weeks after the last treatment, the animals were challenged with the test material in the same manner as the induction treatment. Any allergic reactions were not observed 24 and 48 hours after the challenge in the animals sensitised with the test material.

On the other hand, well defined skin reactions such as erythema and swelling were observed in the animals treated with a positive control, 2,4 -dinitrochlorobenzene.

Based on the above findings, it was concluded that D-523 is not a skin sensitiser.

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

A key study was performed to determine the skin sensitisation potential of FAT 40554 in guinea pigs according to EU Method B.6 (Skin Sensitisation). Skin sensitisation test with D-523 was conducted in male guinea pigs by using Buehler's method.

A dose of 0.5g of the test material was topically applied for induction to the flank of each animal with a lint patch once a week, 3 times in total with the time interval of 1 week. 2 weeks after the last treatment, the animals were challenged with the test material in the same manner as the induction treatment. Any allergic reactions were not observed 24 and 48 hours after the challenge in the animals sensitised with the test material.

On the other hand, well defined skin reactions such as erythema and swelling were observed in the animals treated with a positive control, 2,4 -dinitrochlorobenzene.

Based on the above findings, it was concluded that D-523 is not a skin sensitiser.


Migrated from Short description of key information:
Based on the above mentioned results, the substance does need to be classified according to CLP regulation (Regulation EC No. 1272/2008) and DSD (Directive 67/548/EEC).

Justification for selection of skin sensitisation endpoint:
Non GLP guideline study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to CLP regulation (Regulation EC No. 1272/2008) and DSD (Directive 67/548/EEC), FAT 40554 did not show a skin sensitisation potential in guinea pigs.