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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP study; however, GLP was not compulsory at the time the study was conduced, and the report contains signed QAU statement. The test conduct was in principle quite similar to the OECD TG 402, however with some deviations: - The number of animals used is lower than prescribed by the guideline, however, newer guidelines for acute toxicity studies use only 3 animals per sex and dose and therefore this reduced number should also be sufficient. - Only two dose levels were employed. Moreover, 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. Despite of some deviations and deficiencies the study is scientifically acceptable and suitable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test was conducted according to the method of Noakes and Anderson (A method for determining the dermal toxicity of pesticides. Brit. J. Industr. Med. 26: 59-64, 1969), which was in general compliance with the OECD TG 402.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
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
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: animals bred and raised on the premises
- Age at study initiation: young adult animals were used
- Weight at study initiation: 2 to 3 kg
- Housing: individually, in wire cages
- Diet (e.g. ad libitum): rabbit food - NAFAG, No. 814, Gossau SG, 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%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 14 hrs/10 hrs
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- polyethylene glycol
- Details on dermal exposure:
- FAT 80023/A was suspended to achived the corresponding dosage level, using polyethylene glycol (PAG 400; Fluka AG) as vehicle.
Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
The application volume was 5 and 12 mL/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 0, 1000, 6000 mg/kg bw
- No. of animals per sex per dose:
- Three animals/sex/group were used
- Control animals:
- yes
- Details on study design:
- Approximatively 24 hours prior application, an area of the back of each test animal was shaved.
The test compound was applied onto the skin and the application site was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage.
After 24 hours, the dressing was removed and the application site of each animal was cleaned with lukewarm water.
The skin reaction was assessed by means of the Draize scoring system.
Depending on the dose level, the animals were observed for up to14 or 21 days for mortality and clinical signs of toxicity.
The body weights were recorded immediately prior to dosing and after 7, 14 and 21 days.
At the end of the observation period, the animals were sacrificed for the purpose of necropsy. - Statistics:
- The LD50 including 95% confidence limits was calculated by the Logit model
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 6 000 mg/kg bw
- Mortality:
- One male rabbit of the 6000 mg/kg bw group died on day 8 post exposure.
- Clinical signs:
- other: Compound-related clinical signs in the 1000 and 6000 mg/kg bw groups included sedation, dyspnoea, exophthalmos, ruffled fur, and curved body position. In addition, ataxia was noted in the 6000 mg/kg bw group only. The animals of the control group showed
- Gross pathology:
- Necropsy of the animals sacrificed at the end of the observation period revealed partially congested organs.
- Other findings:
- Skin irritation findings:
In the 1000 mg/kg bw group, skin examination revealed minimal to slight signs of irritation from day 1 to 13 post exposure (erythema with maximal mean score value of 1.3, and edema with maximal mean score value of 0.5)
In the 6000 mg/kg bw group, skin examination revealed minimal to moderate signs of irritation from day 1 to day 21 (erythema with maximal mean score value of 2.8 and edema with maximal mean score value of 2), and moderate necrosis formation was observed at the application site from day 6 to 19.
Any other information on results incl. tables
Mortality data:
Dose [mg/kg bw] |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
|
Males |
|||||
0 |
0/0/3 |
– |
– |
0 |
|
1000 |
0/3/3 |
day 1 - day 19 |
– |
0 |
|
6000 |
1/3/3 |
day 1 - day 19 |
day 8 |
33.3 |
|
LD50 > 2000 mg/kg bw |
|
||||
Females |
|||||
0 |
0/0/3 |
– |
– |
0 |
|
1000 |
0/3/3 |
day 1 - day 19 |
– |
0 |
|
6000 |
0/3/3 |
day 1 - day 19 |
– |
0 |
|
LD50 > 5000 mg/kg bw |
* first number = number of dead animals
second number = number of animals with signs of toxicity
third number = number of animals used
Body weight changes:
FAT 80023/A, acute dermal toxicity in rabbits, body weight findings |
|||
Test dose |
0 |
1000 mg/kg bw |
6000 mg/kg bw |
Mean body weight (kg), males (N=3) |
|||
Day 1 |
2.65 ± 0.15 |
2.53 ± 0.14 |
2.77 ± 0.15 |
Day 7 |
2.81 ± 0.02 |
2.53 ± 0.22 |
2.51 ± 0.01 |
Day 14 |
2.59 ± 0.01 |
2.56 ± 0.44 |
2.81 ± 0.06 |
Day 21 |
n.a. |
n.a. |
2.98 ± 0.03 |
Mean body weight (kg), females (N=3) |
|||
Day 1 |
3.16 ± 0.13 |
2.97 ± 0.26 |
2.91 ± 0.12 |
Day 7 |
3.21 ± 0.27 |
3.01 ± 0.31 |
2.87 ± 0.08 |
Day 14 |
3.20 ± 0.31 |
3.08 ± 0.31 |
3.05 ± 0.18 |
Day 21 |
n.a. |
n.a. |
3.22 ± 0.27 |
n.a., not applicable as sacrifice at day 14 |
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.