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EC number: 203-929-1 | CAS number: 112-03-8
- 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

Endpoint summary
Administrative data
Description of key information
Based on the results from the in vivo irritation study, C18 TMAC is considered to be corrosive to skin as well as eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 09, 1996 to February 09, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae 88400, Biberach
- Age at study initiation: About 3-5 month
- Weight at study initiation: 2.7-3.8 kg
- Housing: In fully air-conditioned rooms in seperate cages arranged in a battery
- Diet: Ssniff K-H (V2333), ad libitum and hay (approximately 15g daily)
- Water: Automatic water dispensers, ad libitum
- Acclimation period: 1 wk under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 50 ± 20%
- Photoperiod: 12h light/12h dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- 0.5g of the test substance pasted with 0.3 mL isotonic saline
- Duration of treatment / exposure:
- 4 hours as well as 3 minutes
- Observation period:
- Examination of the skin took place after 30-60 minutes as well as 24, 48 and 72 hours after removal of the patches. If the irritation persists 72 hours after removal of the patch (treatment 4h), additional reading were performed after 7, 14 and 22 days.
- Number of animals:
- 1 (treatment 4 hours) and 3 (treatment 3 minutes).
- Details on study design:
- The substance was applied over the whole surface of a 2.5x2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. After the exposure, all remnants of the test substance were carefully removed from the skin with warm tap water. Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded
- Irritation parameter:
- erythema score
- Remarks:
- 4 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 22d
- Irritation parameter:
- edema score
- Remarks:
- 4 h exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- erythema score
- Remarks:
- 3 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3 min exposure
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Treatment 4 hours: 30-60 minutes upto 22 days after removal of the plaster the animal showed a very slight to well defined erythema. One day up to 7 days after application a very slight oedema was noted. During the observation period, the treated skin area was sporadically dry, rough, indurated, encrusted, chapped and discoloured large beige. 22 days after application pink coloured new skin and a scar was noted.
Treatment 3 minutes: No sigh of irritation was observed during the whole observation period. - Conclusions:
- Under the study conditions, the test substance was found to be corrosive to rabbit skin.
- Executive summary:
A study was conducted to determine the skin irritation / corrosion of the test substance, C18 TMAC (79.8% active) according to OECD Guideline 404 and EU Method B.4, in compliance with GLP. A paste containing 0.5 g of the test substance (purity of 79.8%) with 0.3 mL isotonic saline was applied under semi-occlusive patches to the clipped dorsal area of four rabbits. One animal was exposed for 4 h and three animals were exposed for 3 min. The test sites were examined for evidence of primary irritation and scored according to Draize method. No signs of irritation were observed during the whole observation period after exposure to 3 min. However, a 4 h exposure resulted in slight to well defined erythema and a slight oedema, visible 30-60 min up to 22 days after removal of the plaster. Between one and seven days after application, slight oedema was noted. During the observation period, the treated skin area was sporadically dry, rough, indurated, encrusted, chapped and discoloured. Twenty-two days after application, pink coloured new skin and a scar was noted. Under the study conditions, the test substance was found to be corrosive to rabbit skin (Kreiling, 1996).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
A study was conducted to determine the skin irritation / corrosion of the test substance, C18 TMAC (79.8% active) according to OECD Guideline 404 and EU Method B.4, in compliance with GLP. A paste containing 0.5 g of the test substance (purity of 79.8%) with 0.3 mL isotonic saline was applied under semi-occlusive patches to the clipped dorsal area of four rabbits. One animal was exposed for 4 h and three animals were exposed for 3 min. The test sites were examined for evidence of primary irritation and scored according to Draize method. No signs of irritation were observed during the whole observation period after exposure to 3 min. However, a 4 h exposure resulted in slight to well defined erythema and a slight oedema, visible 30-60 min up to 22 days after removal of the plaster. Between one and seven days after application, slight oedema was noted. During the observation period, the treated skin area was sporadically dry, rough, indurated, encrusted, chapped and discoloured. Twenty-two days after application, pink coloured new skin and a scar was noted. Under the study conditions, the test substance was found to be corrosive to rabbit skin (Kreiling, 1996).
Eye
In accordance with Annex VII, Section 8.2, Column 2, eye irritation studydoes not need to be conducted because the substance is classified as corrosive to the skin.
Justification for classification or non-classification
Based on the results of thein vivoskin irritation study, the test substance warrants a corrosive, ‘Skin Corr. 1C; H314: Causes severe skin burns and eye damage’ as well as serious eye damage, ‘Eye dam. 1; H31: Causes serious eye damage’ classification according to the EU CLP criteria (Regulation EC 1272/2008). Labelling for this endpoint is covered by the above classifications for skin effects.
With regard to respiratory tract irritation, although C18 TMAC is a very corrosive substance, its low vapour pressure prohibits the occurrence of respiratory irritation by vapour. Further, the classification of corrosive is already considered to implicitly cover the potential of RTI; therefore, an additional Cat.3 is considered to be superfluous (Guidance CLP Ch. 3.8.2.5).
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