Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
An extension of the observation period to up to 21 days could have helped to obtain a more reliable classification for eye irritation. However, it is likely that eye irritation would have persisted for three weeks and that no classification would have been the result of an extended observation period. Classification with R36 is therefore deemed to be a conservative decision.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
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
- Physical state: powder
- 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2 to 3 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 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10%
- Photoperiod (hrs dark / hrs light): 14 hrs/10 hrs

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served for control
Amount / concentration applied:
amount applied 0.1 g
Duration of treatment / exposure:
unspecified as the eyes were not rinsed.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
The test substance (0.1 g) was instilled into the conjunctival sac of the left eye of each test animal. The treated eyes were not rinsed. Ocular reactions were scored at 24, 48 and 72 h, and 4 and 7 days after test substance administration. The Draize scoring system was used for assessment of the ocular lesions, for details, see table below.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 48 - 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 48 - 72h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: (score at day 7 was 2)
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 - 48 - 72h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: (score at day 7 was 1)
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24 - 48 - 72h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24 - 48 - 72h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24 - 48 - 72h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: (score at day 7 was 1)
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 - 48 - 72h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: (score at day 7 was 1)
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 24 - 48 - 72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 24 - 48 - 72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Remarks:
(for each of the following animals)
Basis:
animal: 1, 2, 3 and 5
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 d in two cases (animal 2 and 3)
Remarks on result:
other: (score at day 7 for animal 2 and 3, respectively, was 1; effect was fully reversible within 7 days for animal 1 and 5)
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 24 - 48 - 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 24 - 48 - 72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Remarks:
(for each of the following animals)
Basis:
animal: 1 and 5
Time point:
other: 24 - 48 - 72 h
Score:
0.6
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Remarks:
(for each of the following animals)
Basis:
animal: 2 and 3
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: (score at day 7 for animal 2 and 3, respectively, was 1)
Irritation parameter:
iris score
Remarks:
(for each of the following animals)
Basis:
animal: 4 and 6
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: (no effect seen)
Irritant / corrosive response data:
Triclosan produced irritation characterized by corneal and iridial involvement and conjunctival irritation. The average score of the 24, 48, and 72-h observations for animals ranged from 0.66 to 2.33 for conjunctival redness, from 0.66 to 2.33 for chemosis, from 0.33 to 1 for corneal opacity and from 0 to 1 for iritis. Non reversibility of findings after 7 days was observed in some cases; thus, one criterion for assigning R41 according to the EU Directive 67/548/EEC is met. However, since the OECD 405 recommends an extended period of observation up to 21 days post instillation, it is likely that the findings seen after 7 days would have fully recovered by this time. In the current (29th) ATP of Annex I to Directive 67/548/EEC, triclosan is classified with R36, it is therefore proposed to adopt this current classification.
Other effects:
Ocular discharge was reported in all treated animals; in two cases, discharge still was seen at test ending (i.e. day 7).

Any other information on results incl. tables

Summary of the eye scores for each animal at different reading time points:

Reading time point(h: hour; d: day)

Animal

Treated eyes

Conjunctiva

Cornea

Iris

Erythema

Chemosis

Secretion

Opacity

Area

24 h

1

2

2

2

1

4

1

2

3

3

2

1

4

1

3

3

3

3

1

4

1

4

1

1

2

1

1

0

5

3

2

3

1

4

1

6

2

2

2

1

1

0

48 h

1

2

1

2

1

2

1

2

2

2

2

1

4

1

3

2

2

2

1

4

1

4

1

1

1

0

0

0

5

2

2

3

1

4

1

6

2

1

2

1

1

 0

72 h

1

2

1

2

1

2

0

2

2

2

2

1

4

1

3

1

2

2

1

2

1

4

0

0

1

0

0

0

5

2

0

1

1

1

0

6

0

0

0

0

0

0

7 d

1

0

0

0

0

0

0

2

2

1

2

1

4

1

3

1

1

2

1

2

1

4

0

0

0

0

0

0

5

0

0

0

0

0

0

6

0

0

0

0

0

0

Applicant's summary and conclusion