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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The test material is insufficiently characterized in the report, and no analytical purity was given. However, according to " Triclosan supplement I to EU dossier submitted 18 August 2009", the purity of CIBA-produced Triclosan exceeded 99%, and for FAT 80023/A, a degree of purity of 99.3% was reported. The concentration and quantity of triclosan applied to the test site was not provided in the study report. The study design deviates from current guidelines. However, the study results allow the conclusion that triclosan is a skin irritant, and thus, the study is scientifically acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize Test
Principles of method if other than guideline:
Patch Test as described in the US Association of Food and Drug Officials: "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959)
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FAT 80023/A
- Analytical purity: not specified; however, according to " Triclosan supplement I to EU dossier submitted 18 August 2009", the purity of CIBA-produced Triclosan exceeded 99%, and for FAT 80023/A, a degree of purity of 99.3% was reported.
- No further data provided

Test animals

Species:
rabbit
Strain:
other: Russian Breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): standard rabbit food, ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 1 °C
- Humidity (%): 55 +/- 5%
- Photoperiod (hrs dark / hrs light): 10 hrs/14 hrs

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved, abraded and non-abraded
Vehicle:
water
Controls:
other: untreated skin areas served for control
Duration of treatment / exposure:
24 hour(s)
Observation period:
72 hours after application (i.e. 48 hours after removal of the dressing)
Number of animals:
6
Details on study design:
For treatment a gauze patch of 2.5 x 2.5 cm soaked with the test item was applied to the prepared abraded and non abraded skin.
The patches were covered with an impermeable dressing and were fastened to the body of the rabbit with adhesive tape.
The effects on both intact and abraded skin were tested.
The Draize scale (see table below) was used for scoring the skin reactions at 0 and 48 h post exposure; only the findings referring to the intact skin were considered for assessment of the irritant potential of the test item.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(mean value)
Basis:
animal #1
Time point:
other: 24 - 48 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 48 hours
Irritation parameter:
erythema score
Remarks:
(mean value)
Basis:
animal #2
Time point:
other: 24 - 48 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Remarks:
(mean value)
Basis:
animal #3
Time point:
other: 24 - 48 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 48 hours
Irritation parameter:
erythema score
Remarks:
(mean value)
Basis:
animal #4
Time point:
other: 24 - 48 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 48 hours
Irritation parameter:
erythema score
Remarks:
(mean value)
Basis:
animal #5
Time point:
other: 24 - 48 h
Score:
1.5
Max. score:
2
Reversibility:
not fully reversible within: 48 hours
Irritation parameter:
erythema score
Remarks:
(mean value)
Basis:
animal #6
Time point:
other: 24 - 48 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
(mean value)
Basis:
animal #1
Time point:
other: 24 - 48 h
Score:
1.5
Max. score:
2
Reversibility:
not fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
(mean value)
Basis:
animal #2
Time point:
other: 24 - 48 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
(mean value)
Basis:
animal #3
Time point:
other: 24 - 48 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
(mean value)
Basis:
animal #4
Time point:
other: 24 - 48 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
(mean value)
Basis:
animal #5
Time point:
other: 24 - 48 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
(mean value)
Basis:
animal #6
Time point:
other: 24 - 48 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 48 hours

Applicant's summary and conclusion