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EC number: 418-420-1 | CAS number: -
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 September 1998 - 04 March 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: Waxy solid
- Details on test material:
- Test material name: TBE
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three male young adult New Zealand White rabbits were used. They were within the weight range 2.55-2.70 kg on arrival, and were supplied by Harlan UK, Shaw's Farm, Blackthorn, Bicester, OX6 0TP. They arrived at Elphinstone Research Centre (Inveresk) on 18 August 1998.Animals were acclimatised for at least 7 days prior to commencement of the study.Animals were housed individually in stainless stell cages (77 x 70 x 50 cm) with a Noryl moulded dual lever interior and perforated floor beneath which was an absorbent paper lined tray. Each cage was supplied with an automatic watering valve and a food hopper. Water (mains supply) and Tekland Diet food were supplied ad libitum throughout the study. Cabbage and hay were offered as a supplement to each animalca. twice weekly. Food and water were analysed and were not considered to contain any additional substances in sufficient concentration to have any influence on the outcome of the study.Mean environmental temperatures ranged from minimum and maximum values of 19-20 °C. Mean relative humidity was 47 %. A 12 h light/dark cycle was utilised (light hours 0700-1900) with a minimum of 15 air changes per hour.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g TBE was applied topically to each animal to the wetted dorsal trunk and covered with a water moistened gauze patches (2.5 cm x 2.5 cm), semi-occlusive tape and elastic bandage.
- Duration of treatment / exposure:
- After a contact period of 4 h, the patch was removed and remaining test item washed from the contact area using distilled water. The test sites were delineated.
- Observation period:
- Test sites were examined 1, 24, 48 and 72 h after patch removal. Observations continued up to Day 18 to fully evaluate the reversibility of the reactions, however, as the reactions were deemed irreversible the study was concluded.
- Number of animals:
- 3
- Details on study design:
- 0.5 g TBE was applied topically to each animal to the wetted dorsal trunk and covered with a water moistened gauze patches (2.5 cm x 2.5 cm), semi-occlusive tape and elastic bandage.After a contact period of 4 h, the patch was removed and remaining test item washed from the contact area using distilled water. The test sites were delineated.Test sites were examined 1, 24, 48 and 72 h after patch removal. Skin reactions were graded according to the scoring system detailed in Table 1 and Table 2.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.3
- Max. score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2.7
- Max. score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.3
- Max. score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1.3
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0.3
- Max. score:
- 1
- Irritant / corrosive response data:
- Erythema and oedema skin reaction scores are presented in Table 3 and Table 4, respectively.No oedema was noted in any animal during the observation period.Very slight Erythema was noted in 2 animals and well defined in the third animal 1 h after patch removal. Well defined erythema was noted from 24 h after patch removal up to Day 6 in all animals. Very slight to well defined erythema was noted from Day 7 up to Day 14 in all aniamls.
- Other effects:
- Additional observations (dry and flaky skin) was noted from Day 6 to 18 in two animals and from Day 7 to 18 in the third animal.
Any other information on results incl. tables
Table 3 Erythema Reaction Scores and Body Weight
Animal | Body Weight at Dosing (kg) | Time After Patch Removal (or Day of Study) Reaction Scores | ||||||||||
1 h | 24 h | 48 h | 72 h | Day 5 | Day 6* | Day 7 | Day 9 | Day 11 | Day 14 | Day 15 | ||
1 | 3.35 | 2 | 3 | 3 | 2 | 2 | 2 | 1 | 1 | 0 | 0 | - |
2 | 3.07 | 1 | 2 | 3 | 3 | 3 | 2 | 2 | 1 | 1 | 0 | - |
3 | 3.23 | 1 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 0 |
* animal shaved
- animal not observed
see Table 1 for scoring system
Table 4 Oedema Reaction Scores
Animal | Time After Patch Removal (or Day of Study) Reaction Scores | ||||||||||
1 h | 24 h | 48 h | 72 h | Day 5 | Day 6* | Day 7 | Day 9 | Day 11 | Day 14 | Day 15 | |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
* animal shaved
- animal not observed\
see Table 2 for scoring system
Table 5 Additional Observations
Animal | Observation | Day of Study |
1 | Dry flaky skin evident at test sight | 7, 9, 11, 14, 15, 18 |
2 | Dry flaky skin evident at test sight | 6, 7, 9, 11, 14, 15, 18 |
3 | Dry flaky skin evident at test sight | 6, 7, 9, 11, 14, 15, 18 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of the study , TBE is considered to be irritating to rabbit skin.
- Executive summary:
The acute dermal irritation of TBE was investigated in New Zealand White rabbits.
One group of 3 male rabbits was subjected to a 4 h exposure of 0.5 g of TBE, as supplied, on to the wetted dorsal trunk under a water moistened semi-occlusive patch. The test sites were examined for evidence of irritation 1, 24, 48 and 72 h after patch removal. Observations were continued up to Day 18 to fully evaluate the reversibility of the reactions.
No oedema was noted in any animal during the observation period.
Very slight Erythema was noted in 2 animals and well defined in the third animal 1 h after patch removal. Well defined erythema was noted from 24 h after patch removal up to Day 6 in all animals. Very slight to well defined erythema was noted from Day 7 up to Day 14 in all aniamls.
Dry flaky skin was noted at the test site from Days 6 or 7.
Under the conditions of the study, TBE is considered to be irritating to rabbit skin.
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