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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Principles of method if other than guideline:
None
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

In vitro test system

Test system:
other: dermal application
Source species:
rabbit
Source strain:
New Zealand White
Details on animal used as source of test system:
TEST ANIMALS- Source: Kitayama Labes Co., Ltd., Japan- Age at study initiation: 9 -10 weeks old- Weight at study initiation: 2.42 - 2.90 kg- Housing: Individually housed in aluminium cages.- Diet (e.g. ad libitum): 100 g/day diet (RC-4, Oriental Yeast Co., Ltd)- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: 25- 26 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +-2 °C- Humidity (%): 55 +- 15%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Justification for test system used:
None
Vehicle:
water
Details on test system:
None
Amount/concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 10gm mixed with 10ml water- Concentration (if solution): 0.75 mlVEHICLE- Amount(s) applied (volume or weight with unit): 10ml water
Duration of treatment / exposure:
72 hours
Duration of post-treatment incubation (if applicable):
None
Number of replicates:
None

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Kitayama Labes Co., Ltd., Japan- Age at study initiation: 9 -10 weeks old- Weight at study initiation: 2.42 - 2.90 kg- Housing: Individually housed in aluminium cages.- Diet (e.g. ad libitum): 100 g/day diet (RC-4, Oriental Yeast Co., Ltd)- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: 25- 26 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +-2 °C- Humidity (%): 55 +- 15%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: none
Controls:
yes
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
Skin reactions of erythema and edema were scored 0.5, 24, 48 and 72 hours after removal of patch according to the method of Draize.
Number of animals:
3
Details on study design:
None

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d.; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d.; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
No reactions were observed in any rabbits during observation period.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The irritation potential of the material was found to be 0, and therefore classified as non irritating.
Executive summary:

The aim of this study was to determine the potential of FAT 40554 to induce irritation to rabbits skin. The study was carried out according to GLP methodology and OECD Guideline 404; 92/69/EEC, B.4.

One half of the test material was spread on the 1 inch square lint patch and applied to the intact skin of 3 rabbits with an occlusive tape for 4 hours.

At the end of exposure period, the patches were removed from the skin and the treated area was wiped to remove any remaining material by absorbent cotton dipped in acetone.

Skin reactions of erhthema and edema were scored 0.5, 24, 48 and 72 hours after removal of patch according to the method of Draize. The evaluation of irritation potency of the test material was performed by using primary irritation score.

No skin reactions such as erythema and edema were observed in any rabbits during the observation period. primary irritation score was 0. Therefore, the irritation potential of the material was judged to be negative.

According to the EEC classification of the results obtained 0.5 to 72 hours after removing the bandages FAT 40554 can be classified as non-irritant in albino rabbits.