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EC number: - | 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
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Nanomaterial Zeta potential
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- Endpoint summary
- Stability
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- 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)
Endpoint summary
Administrative data
Description of key information
Based on the oral and dermal LD50 values available for the read across substances, C12 -14 TMAC can be considered to be of moderate acute toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 03, 1982 to August 24, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- Groups of 10 female Wistar rats were exposed to the test substance via oral gavage at 0, 250, 400, 630 and 1000 mg/kg bw. Clinical signs, mortality and bodyweight were recorded during 14 d post-dosing. At study end, a gross macroscopic examination was conducted. LD50 values were calculated by PROBIT analysis.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Präpagen 2916
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst breeding
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Weight at study initiation: 233-253 g
- Fasting period before study: 16 h
- Diet (e.g. ad libitum): Altromin 1324 (Altromin GmbH, Germany)
- Water (e.g. ad libitum): tap water
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test substance was prepared as a 25% solution in water.
- Doses:
- 0, 250, 400, 630 and 1000 mg/kg bw.
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- LD50 calculated by PROBIT analysis (method of Linder and Weber). Confidentiality limits calculated according to Fieller.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 448 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 322 - ca. 593
- Mortality:
- 250 mg/kg bw, 25% concentration: mortality = 2/10 animals
400 mg/kg bw, 25% concentration: mortality = 4/10 animals
630 mg/kg bw, 25% concentration: mortality = 6/10 animals
1000 mg/kg bw, 25% concentration: mortality = 10/10 animals - Clinical signs:
- other: Clinical signs included hyperactivity, high leg posture, crouching, stomach and flanks tucked in, exophtalmia, noisy and sometimes irregular breathing, as well as rapid breathing. On Day 2, all surviving rats still showed noisy breathing. At 630 mg/kg bw,
- Gross pathology:
- Macroscopic examination revealed blood in the lungs, which were in part grey-red discolored, dark brown discoloration of the liver and diffuse digestive tract, in part strongly reddened. The gastrointestinal tract was gelatinous with isolated petechial bleedings. Its appearance was transparent and it was mostly filled with a yellow-reddish mass.
- Interpretation of results:
- other: Category 4 based on CLP criteria
- Conclusions:
- Under the study conditions, the acute oral LD50 for the test substance in rats was equivalent to 448 mg/kg bw (CL = 322 - 593 mg/kg bw).
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance, C12-14 TMAC (active ingredient 40%), in rats. Groups of 10 female Wistar rats were exposed to the test substance via oral gavage at 0, 250, 400, 630 and 1000 mg/kg bw. The test substance was prepared as a 25% solution in water. As it is not clear if the active ingredient corrections have been applied, the doses are mentioned as such. Clinical signs, mortality and bodyweight were recorded during 14 d post-dosing. At study end, a gross macroscopic examination was conducted. LD50 values were calculated by PROBIT analysis. Clinical signs included hyperactivity, high leg posture, crouching, stomach and flanks tucked in, exophtalmia, noisy and sometimes irregular breathing, as well as rapid breathing. On Day 2, all surviving rats still showed noisy breathing. At 630 mg/kg bw, high leg posture and flanks tucked in were recorded until end of Day 4. No clinical signs were apparent as of Day 5. Bodyweights of surviving animals were within normal ranges throughout the study. Macroscopic examination revealed blood in the lungs, which were in part grey-red discolored, dark brown discoloration of the liver and diffuse digestive tract, in part strongly reddened. The gastrointestinal tract was gelatinous with isolated petechial bleedings. Its appearance was transparent and it was mostly filled with a yellow-reddish mass. Under the study conditions, the acute oral LD50 for the test substance in rats was equivalent to 448 mg/kg bw (CL = 322 - 593 mg/kg bw) (Mayer and Weigand, 1982).
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- From 12 June, 1986 to 13 September, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- KL 2 due to RA
- Justification for type of information:
- Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- One animal in the lowest dose group was not observed for clinical findings at 4 h after dosing on Day 0. this deviation does not affect the scientific validity or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- One animal in the lowest dose group was not observed for clinical findings at 4 h after dosing on Day 0. this deviation does not affect the scientific validity or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- other: Toxic Substances Control Act (TSCA) Health Effects Test Guidelines
- Deviations:
- yes
- Remarks:
- One animal in the lowest dose group was not observed for clinical findings at 4 h after dosing on Day 0. this deviation does not affect the scientific validity or integrity of the study.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, Michigan
- Weight at study initiation: 205-262 g
- Fasting period before study: 18 h
- Housing: Individually housed in wire-mesh cages
- Diet: Purina certified rodent chow # 5002, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: Minimum 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): more than 40%
- Photoperiod (h dark/h light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 0.93 mL/kg
- Doses:
- 0, 512, 620, 750 and 908 mg/kg bw .
- No. of animals per sex per dose:
- Five animals per sex per dose except for the highest dose which has only 5 males.
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of clinical observation: 1, 2.5 and 4 h after dosing on Day 0 and subsequently once daily for 14 d.
- Frequency of weighing: On Days 0, 7 and 14
- Necropsy of survivors performed: Yes
- Examinations performed: Clinical signs, body weight and gross pathological examination. - Statistics:
- LD50 values and slopes (with 95% confidence limit) were calculated by method of Litchfield and Wilcoxon.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 684 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 629 - ca. 743
- Remarks on result:
- other: i.e., equivalent to 226 mg a.i./kg bw
- Mortality:
- There was no mortality in the 512 mg/kg bw group while 3 out of 10 and 7 out of 10 rats died in the 620 and 750 mg/kg bw groups, respectively. All the five animals died receiving the highest tested dose of 908 mg/kg bw.
- Clinical signs:
- other: Four males in the 512 mg/kg bw group had yellowish anogenital staining during early study period and one of these animals had diarrhoea. Several animals in the 620, 750 and 908 mg/kg bw showed anogenital staining, diarrhoea, brown staining around the mout
- Gross pathology:
- Changes were observed in the adrenal glands, brain, kidneys, stomach and intestines for more than one and half of all rats died during study. Abnormalities in the liver were found in of 7/15 of the dead rats. No significant changes for all tissues examined for rats that were terminally sacrificed, including control group.
- Interpretation of results:
- other: Category 3 based on CLP criteria
- Conclusions:
- Based on the results of the read across study, the oral LD50 value of the test substance can also be considered to be equivalent to 226 mg a.i./kg bw).
- Executive summary:
A study was conducted to determine the acute oral toxicity of the read across substance, Coco TMAC (active ingredient 33%), in Sprague-Dawley rats according to OECD 401 and EPA OPP 81-2 Guidelines, in compliance with GLP. Groups of 10 fasted animals (five males and five females per dose except for five males only at the highest dose) were administered 0, 512, 620, 750 or 908 mg/kg bw of the test substance via the oral route. The animals were observed for 14 days after dosing and then sacrificed and subjected to gross pathological examination. There was no mortality in the 512 mg/kg bw group while 3 out of 10 and 7 out of 10 rats died in the 620 and 750 mg/kg bw groups, respectively. All five animals in the highest dose group (908 mg/kg bw) died. Under the study conditions, the acute oral LD50 of the test substance in Sprague-Dawley rats was determined to be 684 mg test substance/kg bw (i.e., equivalent to 226 mg a.i./kg bw) with 95% confidence limits of 629−743 mg/kg bw (Naas, 1987). Based on the results of the read across study, the oral LD50 value of the test substance can also be considered to be equivalent to 226 mg a.i./kg bw).
Referenceopen allclose all
In the range-finding study, all the rats dosed at 1000, 1500 and 2000 mg/kg bw died while rats dosed at 500 mg/kg bw survived.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 226 mg/kg bw
- Quality of whole database:
- Good quality study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- From 22 February, 1988 to 24 March, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- KL2 due to RA
- Justification for type of information:
- Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Toxic Substances Control Act (TSCA) acute dermal toxicity guideline
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mochican Valley Rabbitry, Loidonville, Ohio
- Weight at study initiation: 2140 to 2990 g
- Housing: individual suspended wire-mesh cages
- Diet (e.g. ad libitum): Purina Certified rabbit chow # 5322, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: Minimum 7 d
ENVIRONMENTAL CONDITIONS
- Humidity (%): 49-74%
- Photoperiod (h dark / h light): 12 h / 12 h - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Shaved intact dorsal skin
- % coverage: 20%
- Type of wrap if used: Test substance was applied under gauze binders that were secured with non-irritating tape. - Duration of exposure:
- 24 h
- Doses:
- 0, 520, 1020 and 2000 mg/kg bw.
- No. of animals per sex per dose:
- Five animals per sex per test group, three animals per sex in control group.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: Animals were observed at 1, 3 and 4 h post-dosing on Day 0 and twice daily for mortality and once daily for clinical observations for 14 d. Application sites were examined for erythema, oedema and other dermal findings at 30−60 min after bandage removal and daily thereafter for 13 d. Erythema and oedema were graded according to Draize method.
- Frequency of observations and weighing: Day 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- LD50 and slopes (with 95% confidence limits) were calculated by method of Litchfield and Wilcoxon.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 300 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 800 - ca. 1 900
- Remarks on result:
- other: i.e., equivalent to 429 mg a.i./kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 900 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 1 500 - ca. 2 400
- Remarks on result:
- other: i.e., equivalent to 627 mg a.i./kg bw
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 600 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 1 200 - ca. 2 100
- Remarks on result:
- other: i.e., equivalent to 588 mg a.i./kg bw
- Mortality:
- Control: 0/6 animals
520 mg/kg bw: 0/10 animals
1020 mg/kg bw: 2/5 males and 0/5 females
2000 mg/kg bw: 4/5 males and 3/5 females - Clinical signs:
- other: Lethargy and ataxia were major clinical findings. Other findings included hypothermia, decreased respiratory rate, laboured respiration, nasal discharge, decreased defecation, emaciation, red staining around the mouth, diarrhoea.
- Gross pathology:
- Treatment-related abnormality on the application sites of all rabbits. No substance-related internal abnormalities in rabbits that died during study or terminally sacrificed.
- Other findings:
- Test substance induced moderate to severe erythema and oedema with other significant dermal findings such as necrosis, desquamation, scabbing, eschar, exfoliation, fissuring and blenching. Subcutaneous haemorrhage was present on the application sites of one rabbit in the 2000 mg/kg bw group that survived and all animals that died.
- Interpretation of results:
- other: Category 3 based on CLP criteria
- Conclusions:
- Based on the results of the read across study, the acute dermal LD50 value of the test substance, C12-14 TMAC, can also be considered to be 528 mg a.i./kg bw (429-627 mg a.i./kg bw for males and females).
- Executive summary:
A study was conducted to determine the acute dermal toxicity of the read across substance, Coco TMAC (active ingredient 33%), in albino rabbits according to OECD 402 Guideline, in compliance with GLP. The test substance at 0, 520, 1,020 or 2,000 mg/kg bw was applied under semi-occlusive conditions for 24 h in a single application to the shaved, intact skin of groups of 10 rabbits (five per sex). Animals were observed at 1, 3 and 4 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, clinical signs and skin response for 14 d. There was no mortality in the control or 520 mg/kg bw group. Two males died in the 1,020 mg/kg bw group while 4 males and 3 females died in the 2,000 mg/kg bw group. Under the conditions of the test, the acute dermal LD50 for male and female albino rabbits were determined to be 1,300 mg/kg bw (i.e., equivalent to 429 mg a.i./kg bw) and 1,900 mg/kg bw (i.e., equivalent to 627 mg a.i./kg bw) respectively, and the combined dermal LD50 value for males and females was determined to be 1,600 mg/kg bw (i.e., equivalent to 528 mg a.i./kg bw). Considering the generally low dermal absorption potential of Coco TMAC (<10% in Bartnik and Wingen, 1979 study), the observed systemic effects and mortality were attributed to the severe corrosive properties of the test substance following 24 h exposure rather than real systemic toxicity. This is supported by the relatively limited observations on internal organs upon necropsis of the animals that died (Naas, 1988). Based on the results of the read across study, the acute dermal LD50 value of the test substance, C12 -14 TMAC, can also be considered to be 528 mg a.i./kg bw (429-627 mg a.i./kg bw for males and females).
Reference
Only (systemic) pathology observed in animals sacrificed at termination were kidney abnormalities (pale, reddened, pitted) in 5/21 of the terminally sacrificed dosed rabbits. Pale kidneys were also observed for one female in the control group. The skin of the animals that died showed eschar, subcutaneous haemorrhage, blanching and thickening. Internal abnormalities included hemorrhagic thymus glands (6/9) (typical agonal change), red foci or dark red area in the stomach (3/9), brain haemorrhages (3/9) and liver soft or pale and soft (2/9). No internal abnormalities were observed among rabbits that died which could be attributed to the test substance. There were no test substance related internal changes for rabbits that were terminally sacrificed.
Considering the generally low dermal absorption of Coco TMAC (<10% in Bartnik and Wingen, 1979 study), it is likely that severe corrosive effects upon the 24 h exposure of the concentrated product were more cause to the death of the animals, than real systemic toxicity. This is supported by the relatively limited observations on internal organs upon necropsis of the animals that died. The most commonly observed internal abnormalities were hemorrhagic thymus glands (6/9), which is a typical agonal change, and likely not a specific sign of toxicity.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 528 mg/kg bw
- Quality of whole database:
- Guideline and GLP compliant study
Additional information
Oral
Study 1: A study was conducted to determine the acute oral toxicity of the test substance, C12-14 TMAC, in rats. Groups of 10 female Wistar rats were exposed to the test substance via oral gavage at 250, 400, 630 and 1000 mg/kg bw. Clinical signs, mortality and bodyweight were recorded during 14 d post-dosing. At study end, a gross macroscopic examination was conducted. LD50 values were calculated by PROBIT analysis. Clinical signs included hyperactivity, high leg posture, crouching, stomach and flanks tucked in, exophtalmia, noisy and sometimes irregular breathing, as well as rapid breathing. On Day 2, all surviving rats still showed noisy breathing. At 630 mg/kg bw, high leg posture and flanks tucked in were recorded until end of Day 4. No clinical signs were apparent as of Day 5. Bodyweights of surviving animals were within normal ranges throughout the study. Macroscopic examination revealed blood in the lungs, which were in part grey-red discolored, dark brown discoloration of the liver and diffuse digestive tract, in part strongly reddened. The gastrointestinal tract was gelatinous with isolated petechial bleedings. Its appearance was transparent and it was mostly filled with a yellow-reddish mass. Under the study conditions, the acute oral LD50 for the test substance in rats was equivalent to 448 mg/kg bw (CL = 322 - 593 mg/kg bw) (Mayer and Weigand, 1982).
Study 2: A study was conducted to determine the acute oral toxicity of the read across substance, Coco TMAC (active ingredient 33%), in Sprague-Dawley rats according to OECD 401 and EPA OPP 81-2 Guidelines, in compliance with GLP. Groups of 10 fasted animals (five males and five females per dose except for five males only at the highest dose) were administered 0, 512, 620, 750 or 908 mg/kg bw of the test substance via the oral route. The animals were observed for 14 days after dosing and then sacrificed and subjected to gross pathological examination. There was no mortality in the 512 mg/kg bw group while 3 out of 10 and 7 out of 10 rats died in the 620 and 750 mg/kg bw groups, respectively. All five animals in the highest dose group (908 mg/kg bw) died. Under the study conditions, the acute oral LD50 of the test substance in Sprague-Dawley rats was determined to be 684 mg test substance/kg bw (i.e., equivalent to 226 mg a.i./kg bw) with 95% confidence limits of 629−743 mg/kg bw (Naas, 1987). Based on the results of the read across study, the oral LD50 value of the test substance can also be considered to be equivalent to 226 mg a.i./kg bw).
In absence of purity correction details for the study with the test substance, the oral LD50 value from the read across substance has been considered further for hazard assessment.
Dermal
A study was conducted to determine the acute dermal toxicity of the read across substance, Coco TMAC (active ingredient 33%), in albino rabbits according to OECD 402 Guideline, in compliance with GLP. The test substance at 0, 520, 1,020 or 2,000 mg/kg bw was applied under semi-occlusive conditions for 24 h in a single application to the shaved, intact skin of groups of 10 rabbits (five per sex). Animals were observed at 1, 3 and 4 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, clinical signs and skin response for 14 d. There was no mortality in the control or 520 mg/kg bw group. Two males died in the 1,020 mg/kg bw group while 4 males and 3 females died in the 2,000 mg/kg bw group.Under the conditions of the test, the acute dermal LD50 for male and female albino rabbits were determined to be 1,300 mg/kg bw (i.e., equivalent to 429 mg a.i./kg bw) and 1,900 mg/kg bw (i.e., equivalent to 627 mg a.i./kg bw) respectively, and the combined dermal LD50 value for males and females was determined to be 1,600 mg/kg bw (i.e., equivalent to 528 mg a.i./kg bw). Considering the generally low dermal absorption potential of Coco TMAC (<10% in Bartnik and Wingen, 1979 study), the observed systemic effects and mortality were attributed to the severe corrosive properties of the test substance following 24 h exposure rather than real systemic toxicity. This is supported by the relatively limited observations on internal organs upon necropsis of the animals that died (Naas, 1988). Based on the results of the read across study, the acute dermal LD50 value of the test substance, C12 -14 TMAC, can also be considered to be 528 mg a.i./kg bw (429-627 mg a.i./kg bw for males and females).
Inhalation
The substance is a coarse grained solid with a low vapour pressure at room temperature. Due to its physical state and physical chemical properties it is unlikely that this substance will form inhalable dust, mist or fumes during normal processing and use conditions. In case inhalable forms of the substance are created under particular conditions (e.g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.
Justification for classification or non-classification
Based on the acute toxicity data (oral LD50 = 226 mg a.i./kg bw and dermal LD50 = 528 mg a.i./kg bw) of the read across substance, Coco TMAC, C12-14 TMAC is considered to be classified as 'Acute Tox.3, H301: toxic if swallowed' for oral route and 'Acute Tox.3, H311: toxic in contact with skin' for dermal route, according to EU CLP criteria (Regulation EC 1272/2008).
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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