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EC number: 222-182-2 | CAS number: 3380-34-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
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:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Triclosan
- EC Number:
- 222-182-2
- EC Name:
- Triclosan
- Cas Number:
- 3380-34-5
- Molecular formula:
- C12H7Cl3O2
- IUPAC Name:
- 5-chloro-2-(2,4-dichlorophenoxy)phenol
- 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
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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