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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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Nine induction exposures, and reduced number of animals (10 and 5 instead of 20 and 10 for treated and control, respectively)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was performed before LLNA was formally validated and available as OECD guideline in 2002.
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): Triclosan
- Physical state: white crystalline powder
- Analytical purity: 99.7%
- Lot/batch No.: #5.2.0211.0
- Stability under test conditions: stable at room temperature for 5 years
- Storage condition of test material: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farms, South Brunswick, NJ
- Age at study initiation: young adult animals were used
- Weight at study initiation: males 305-345 g, females 304-361 g
- Housing: group housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): Pelleted purina Guinea Pig Chow, ad libitum
- Water (e.g. ad libitum): Filtered tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22 °C
- Photoperiod (hrs dark / hrs light): 12 hrs / 12 hrs
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- For induction, a test dose of 25% test item in propylene glycol was initially selected, however, due to the severity of irritation after the second and fourth application, the induction concentration was reduced to 10% for inductions 3 and 4, and further decreased to 2% for inductions 5 through 9.
For challenge, a dose of 5% test item in propylene glycol was selected on the basis on a preliminary range-finding test.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- For induction, a test dose of 25% test item in propylene glycol was initially selected, however, due to the severity of irritation after the second and fourth application, the induction concentration was reduced to 10% for inductions 3 and 4, and further decreased to 2% for inductions 5 through 9.
For challenge, a dose of 5% test item in propylene glycol was selected on the basis on a preliminary range-finding test.
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
Prior to testing for sensitisation, a pre-test was conducted for determination of the primary irritation of the test material. For this purpose, the fur was removed by clipping the dorsal area and flanks of each test animal. This area was divided into 4 test sites and the test substance was diluted with propylene glycol to yield concentrations of 95%, 75%, 50%, 25%, 10%, 7%, 5%, 2% and 1%. Each concentration was applied to a test site using an occlusive 25 mm Hilltop Chamber. The sites were wrapped with non-allergenic Durapore adhesive tape. After 6 hours of exposure, the chambers were removed. Twenty-four hours after application, each site was evaluated for local skin reactions (erythema). From these results, the highest concentration that produced responses in 4 guinea pigs no more severe than 2 scores of 0.5 and 2 scores of zero was established and used for challenge. Based on these findings, the selected concentration for challenge was 5% solution ot test item in propylene glycol.
MAIN TEST:
On the day before initiation, the fur of the test animals was removed by clipping the dorsal area and flanks.
A-INDUCTION
Initially, a test dose of 25% test item in propylene glycol was selected for induction; however, due to the severity of irritation after the second and fourth application, the induction concentration was reduced to 10% for inductions 3 and 4, and further decreased to 2% for inductions 5 through 9.
The test substance was applied onto the skin of each test animal 3 times each week for a 3 week induction period total of 9 applications). The application site was maintained under occlusive conditions for an exposure period of 6 hours; after removal of the dressing, the application sites were gently wiped with 95% ethanol and a clean tewel to remove any residual substance.
B-CHALLENGE
Twelve days after the last induction, a challenge dose of the test item (5% in propylene glycol) was applied to a naive site on each guinea pig, similarly as described above. These sites were evaluated for a sensitization response (erythema) at 24 and 48 hours after the challenge application.
READING:
Approximately 24 and 48 hours after each induction and challenge dose, the application sites were examined for skin reactions, and the findings were scored according to following system:
0 = no reaction
0.5 = very faint erythema, usually non-confluent
1 = faint erythema usually confluent
2 = moderate erythema
3 = severe erythema with or without edema
EVALUATION OF THE SENSITIZING RESPONSE:
In order to evaluate the sensitization response, 2 indices were used; one for incidence and one for severity for both test and positive control animals.
The incidence index was calculated to evaluate the incidence of erythema (sensitization response) 24 and 48 hours after challenge according to the following formula: lncidence Index = Number of erythema scores> 0.5/Number of animals evaluated
The severity index (sensitization produced) at 24 and 48 hours after challenge was calculated using the following formula:
Severity Index = Sum of erythema scores /Number of animals evaluated
The following criteria were used to classify the test substance as a potential contact sensitizer:
1 - At the 24 and/or48 hour scoring interval, 20% or more (i.e. incidence index of 0.2 or more) of the test animals exhibit a positive response (scores>
0.5) in the absence of similar results in the naive control group.
2 - The positive reaction must persist to 48 hours in at least one test animal - Challenge controls:
- Two naïve control groups (5 animals for the test substance and 5 for the positive control) were maintained under the same environmental conditions and treated with the test or positive control substance at challenge only.
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-Dinitrobenzene (DNCB)
Results and discussion
- Positive control results:
- Positive Control Animals (0.03% DNCB in acetone): Twenty-four hours after challenge, all control sites exhibited signs of a sensitization response (faint to severe erythema; these reactions persisted to 48 hours in all animals.
Positive Naive Control Animals (0.03% DNCB in acetone): Very faint erythema was noted at 3 of 5 positive naive control sites 24 hours after challenge. Irritation persisted to 48 hours in 2 guinea pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% test item in propylene glycol
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema graded 0.5 was reported for the 6 test sites
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% test item in propylene glycol. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: very faint erythema graded 0.5 was reported for the 6 test sites.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% test item in propylene glycol
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- the findings as decribed above persisted in 5 cases
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% test item in propylene glycol. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: the findings as decribed above persisted in 5 cases.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: naive test animals treated with the test item at challenge only.
- Dose level:
- 5% test item in propylene glycol
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Clinical observations:
- very faint erythema graded 0.5 was noted in 2 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: other: naive test animals treated with the test item at challenge only.. Dose level: 5% test item in propylene glycol. No with. + reactions: 2.0. Total no. in groups: 5.0. Clinical observations: very faint erythema graded 0.5 was noted in 2 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.03% DNCB in acetone
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- all animals showed signs indicative of skin sensitisation (faint to severe erythema)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.03% DNCB in acetone. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: all animals showed signs indicative of skin sensitisation (faint to severe erythema).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.03% DNCB in acetone
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- reaction similar as seen after 24 hours
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.03% DNCB in acetone. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: reaction similar as seen after 24 hours.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: positive naive control treated with DNCB at challenge only
- Dose level:
- 0.03% DNCB in acetone
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Clinical observations:
- very faint erythema graded 0.5 was seen in 3 cases
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: other: positive naive control treated with DNCB at challenge only. Dose level: 0.03% DNCB in acetone. No with. + reactions: 3.0. Total no. in groups: 5.0. Clinical observations: very faint erythema graded 0.5 was seen in 3 cases.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: positive naive control treated with DNCB at challenge only
- Dose level:
- 0.03% DNCB in acetone
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Clinical observations:
- the findings seen after 24 hours persisted in 2 cases to 48 hours
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: positive naive control treated with DNCB at challenge only. Dose level: 0.03% DNCB in acetone. No with. + reactions: 2.0. Total no. in groups: 5.0. Clinical observations: the findings seen after 24 hours persisted in 2 cases to 48 hours.
Any other information on results incl. tables
INDUCTION:
All test sites exhibited very faint to severe erythema during the induction phase.
Edema, desquamation, hyperkeratosis and/or eschar were noted at many sites.
Due to the severity of irritation after the second and fourth inductions, the induction concentration of the test substance was reduced from a 25% solution in propylene glycol to a 10 and then a 2% solution. A decrease in the overall severity of irritation was noted following each reduction in induction concentration.
CHALLENGE:
Twenty-four hours after challenge, very
faint erythema was noted at 6 test sites. Irritation persisted in 5
animals through 48 hours. Although no irritation was noted at any naive
sites 24 hours after challenge, 2 naive animals exhibited very faint
erythema at 48 hours.
All positive control sites exhibited very faint to severe erythema
during the induction phase. Eschar, hyperkeratosis and/or desquamation
were evident at all sites. Twenty-four and 48 hours after challenge, all
positive control sites exhibited signs of a sensitization response
(faint to severe erythema). Twenty hours after challenge, very faint
erythema was noted at 3 of 5 positive naive control sites.Irritation
persisted to 48 hours in 2 affected animals.
CLINICAL SYMPTOMS:
All animals gained weight and no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour were reported.
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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