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Diss Factsheets
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EC number: 222-048-3 | CAS number: 3327-22-8
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The key oral study, conducted in a manner similar to (the now deleted) OECD 401 involved gavage administration of one of five doses of a 60% solution of CHPTAC to male and female rats. An LD50 value of 3.2 mL/kg bw was reported (equivalent to 3688 mg/kg bw, or 2213 mg/kg bw for pure CHPTAC).
The key dermal study, conducted according to OECD 402, involved 24-h occluded contact with the test material (65% aqueous CHPTAC). An LD50 value in rats greater than 2348 mg/kg bw was derived for the test material, that has been said to equate to 1526 mg/kg bw for 100% CHPTAC.
No suitable data are available for the inhalation route.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific pinciples
- Principles of method if other than guideline:
- Method: other: LD50 was calculated according to the method of Weil (Biometrics 8 (1952), 249-263)
Method similar to the (now deleted) OECD 401. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: SPF-bred albino rats (Cpb: WU; Wistar random)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for the breeding of laboratory animals, TNO, Zeist, NETHERLANDS.
- Weight at study initiation: 84-116 g (males); 76-100 g (females)
- Fasting period before study: not stated
- Housing: stainless steel cage (numer/cage not stated)
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 1
- Humidity (%): no data
- Air changes (per hr): 'well ventilated'
- Photoperiod (hrs dark / hrs light): no data
- Route of administration:
- oral: gavage
- Vehicle:
- other: undiluted
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED: - Doses:
- 1.92, 2.30, 2.76, 3.31, 3.98 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighed on days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- LD50 according to: Weil (1952). Biometrics 8, 249.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3.2 mL/kg bw
- 95% CL:
- 2.66 - 3.84
- Remarks on result:
- other: 60% CHPTAC
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 688 mg/kg bw
- Remarks on result:
- other: 60% CHPTAC
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 213 mg/kg bw
- Remarks on result:
- other: 100% CHPTAC
- Mortality:
- See Table 1 in "Any other information on results incl. tables".
- Clinical signs:
- No clinical signs amongst survivors.
- Body weight:
- No treatment-related effect on body weight.
- Gross pathology:
- No abnormal gross pathology.
- Other findings:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A reliable study conducted very largely in compliance with a standard guideline but without GLP, identified an LD50 value for 60% CHPTAC of 3.20 mL/kg bw in male and female rats. This would be equivalent to an LD50 for 100% CHPTAC of 2213 mg/kg bw.
- Executive summary:
In an acute toxicity study, the toxic potential of CHPTAC was tested dermally on male and female rats. A LD 50 value for 60% CHPTAC of 3.20 mL/kg bw was identified in male and female rats. This would be equivalent to an LD50 for 100% CHPTAC of 2213 mg/kg bw.
Reference
Table 1: Mortality
Dose |
Mortality (dead/total) |
||
Male |
Female |
Combined |
|
1.67 |
1/5 |
0/5 |
1/10 |
2.00 |
0/5 |
1/5 |
1/10 |
2.40 |
2/5 |
1/5 |
3/10 |
2.88 |
4/5 |
3/5 |
7/10 |
3.46 |
4/5 |
2/5 |
6/10 |
Death occurred within 1 h of dosing; survivors recovered and there were no overt signs of toxicity. No gross abnormalities were identified on examination.
LD50 (Servon XRK 60) = 3.20 mL/kg bw. or 3.68 g/kg bw (TS specific gravity 1.15)
Equivalent to an LD50 for 100% CHPTAC of 2213 mg/kg bw/day
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 213 mg/kg bw
- Quality of whole database:
- Study conducted similar to guideline
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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: Guideline study witha acceptable restrictions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 h
- Doses:
- 2 mLkg bw 65% CHPTAC (1174 mg/mL for 65% CHPTAC) = 2348 mg/kg bw
- No. of animals per sex per dose:
- 5
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 348 mg/kg bw
- Remarks on result:
- other: 65% CHPTAC
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 526 mg/kg bw
- Remarks on result:
- other: for 100% CHPTAC (according to RAR, 2008).
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The dermal LD50 value was found to be greater than 2348 mg/kg bw which corresponds to 1526 mg/kg of pure CHPTAC.
- Executive summary:
A limit test was conducted to assess the dermal toxicity of the test substance (65% CHPTAC). Under the experimental conditions the dermal LD50 value was found to be greater than 2348 mg/kg which corresponds to 1526 mg/kg of pure CHPTAC.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 526 mg/kg bw
- Quality of whole database:
- Guideline study
Additional information
ORAL
The key oral study was chosen from 4 studies of reliability 2 (reliable with restrictions) as the most recent of those for which sufficient data were available for review during entry to IUCLID5. Findings from the remaining three studies supported those of the key study. Where adequate data were available the LD50 values for pure CHPTAC were in every case greater than 2000 mg/kg bw/day. For a further two studies (reliability 4) an LD50 of >2000 mg/kg bw/day was also given, apparently in relation to an aqueous solution of CHPTAC, giving a conversion to an LD50 lower than 2000 mg/kg bw/day for the pure substance. However, sufficient details were not available during entry to IUCLID5 for this to be reliably ascertained.
The study selected by FIN to provide the LD50 used in risk characterization (Kynoch et al., 1982/Dynamit Nobel, 1982) was not available during entry to IUCLID5. The LD50 value identified in this study is very similar to that of the key study.
DERMAL
The key dermal study was chosen from two very similar studies in the rat. The findings of the supporting study confirm those of the key study.
Justification for classification or non-classification
Based on the available data, classification via the oral route is not required (Regulation (EC) No 1272/2008; Directive 67/548/EEC).
The studies identified do not indicate classification via the dermal route for the test material (Regulation (EC) No. 1272/2008; Directive 67/548/EEC). However, conversion to account for the concentration of CHPTAC in the test material means that the tested dose of pure CHPTAC was slightly lower than the upper value (2000 mg/kg bw) above which classification would not be required.
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.
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