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EC number: 216-971-0 | CAS number: 1709-70-2
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study not performed to any reported guidance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Not specified
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- 3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol
- EC Number:
- 216-971-0
- EC Name:
- 3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol
- Cas Number:
- 1709-70-2
- Molecular formula:
- C54H78O3
- IUPAC Name:
- 3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol
- Details on test material:
- A 100 kg sample of lonox 330, batch number 89/5/6232, purity 98% was supplied by Shell Chemical Company, Carrington.
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 26 Beagle hounds, aged about five months and bred at this laboratory were used. The dogs were inoculated at three months with a vaccine consisting of living, modified, tissue culture adapted distemper virus, inactivated canine hepatitis virus and inactivated leptospira bacteria. They were also treated for nematode parasites with piperazine adipate.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- Not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2000, 10000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 0 - 5 males & 5 females
2000 - 4 males & 4 females
10000 - 4 males & 4 females - Control animals:
- yes, plain diet
- Details on study design:
- Groups of four males and four females, housed individually, received diets containing 2,000 and 10,000 ppm Ionox 330, an intake of 1 ppm in the dogs used for this experiment being equivalent to 0.05 mg/kg/day.
Control groups, five males and five females, received untreated powdered diet (Powdered 'More-Meat' Dog Food. Quaker Oats Ltd., Southall, Middlesex). Dogs within each of the available litters were allocated at random to the various treatments. Here this allocation was not possible animals of a similar age and weight were used. - Positive control:
- Not specified
Examinations
- Observations and examinations performed and frequency:
- Daily records of general health and behaviour were made and body weights were recorded weekly. Blood samples were taken prior to the experiment. After six and 12 weeks exposure and thereafter at three monthly intervals. Haematological examinations carried out on all blood samples comprised haemoglobin and packed cell volume determinations and erythrocyte, leucocyte and di-ferential leucocyte counts. Clinical chemical determinations were made of serum urea and total protein. Serum protein fractions were determined by paper electrophoresis using LKB paper electrophoresis equipment (LKB buffer pH 8.6, μ = 0.1). Urine examinations and bromsulphthalein (BSP) liver function tests were carried out on the control and top dose groups every four months.
- Sacrifice and pathology:
- At autopsy, a gross pathological examination was made and the major visceral organs weighed. Histopathological examination was made of haematoxylin and eosin stained sections of liver, thyroid, parathyroid, heart, lungs, spleen, kidneys, adrenals, small and large intestines, stomach, pancreas, skin, skeletal muscle, salivary glands, lymph nodes, bladder, testes, prostate, uterus, ovaries, Fallopian tubes, eye and brain of all animals.
- Other examinations:
- No data
- Statistics:
- Not specified
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Throughout the experiment, the general health, behaviour and body weights of the dogs remained unaffected by the feeding of Ionox 330. During the first 12 weeks of the experiment, one female from each treatment group, all from one litter, became lethargic, anorexic and pyrexial. Other symptoms developed and distemper was diagnosed. These symptoms occurred four weeks after vaccination for distemper, leptospirosis and hepatitis of all puppies in the kennel. As a result of this infection, the 2,000 ppm dog was killed in the fourth week and the 10,000 ppm animal in the 12th week of the experiment. The pathological findings confirmed the clinical diagnosis. During the eighth week, the affected control group female recovered within seven days and showed no further effects.
No changes in organ weights or organ/body weight ratios were observed. The haematology and clinical chemistry of the dogs remained unaffected throughout the exposure, the minor variations observed not being considered of any biological significance.
At autopsy, no gross or microscopic changes attributable to the exposure were found. Lesions associated with ascarid infestation were detected in the livers of both treated and control animals. Evidence of pulmonary and renal disease was also found in all the animals.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 10 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1 – Summary of the pathological findings in dogs fed Ionox 330 for two years
1a - Dogs killed during the experiment
Dietary Concn (ppm) |
Animal Number |
Time of Exposure (weeks) |
Gross and microscopic pathological findings |
2000 |
357 Female |
4 |
Focal meningitis, Peri-arteritis of large intestine. Haemorrhage of lymph nodes. |
10000 |
360 Female |
12 |
Bronchopneumonia with numerous abscesses. |
1b - After two years
Dietary Concn (ppm) |
Animal Number |
Sex |
Gross and microscopic pathological findings |
10000 |
340 |
Male |
Hepatic granulomas. Nephritis. |
|
348 |
Male |
Negative. |
|
351 |
Male |
Hepatic granulomas. Nephritis. |
|
352 |
Male |
Bronchopneumonia. Pyelonephritis. |
|
321 |
Female |
Pneumonitis with granulomas. Hepatic granulomas. Nephritis. |
|
343 |
Female |
Hepatic granulomas. |
|
356 |
Female |
Hepatic granulomas. Nephritis. |
2000 |
361 |
Male |
Pulmonary fibrosis. Parathyroid adenoma. |
|
363 |
Male |
Focal pneumonitis. |
|
339 |
Male |
Hepatic granulomas. Nephritis. |
|
354 |
Male |
Hepatic granulomas. |
|
342 |
Female |
Pneumonitis with granulomas. Hepatic ganulomas. Pyelitis. |
|
338 |
Female |
Nephritis and pyelitis. |
|
345 |
Female |
Hepatic granulomas. Renal abscess. Resolving pneumonia. |
0 |
347 |
Male |
Hepatic – peripertal inflammation. |
|
349 |
Male |
Focal pulmonary fibrosis. Fatty infiltration myocardium. |
|
350 |
Male |
Interstitial pneumonitis with fibrosis. Mild pyelitis. |
|
353 |
Male |
Bronchitis. |
|
355 |
Male |
Patchy pneumonitis. Hepatic granulomas. |
|
359 |
Female |
Hepatic granulomas. Nephritis. |
|
341 |
Female |
Pneumonitis. Hepatic granulomas. Pyelitis. |
|
344 |
Female |
Hepatic granulomas. Nephritis. |
|
346 |
Female |
Patchy pneumonitis. Hepatic granulomas. Nephritis. |
|
358 |
Female |
Hepatic granulomas. |
Table 2 – The organ weights and organ/body weight ratios of dogs fed Ionox 330 for two years
Dietary Concn (ppm) |
Number of Animals |
Terminal body wt (kg) |
Organ weight (g) |
|||||
Brain |
Heart |
Liver |
Kidneys |
Testes |
||||
Males |
|
|||||||
0 |
5 |
14.8 |
83.5 |
126.1 |
451 |
678 |
16.2 |
|
2000 |
4 |
15.2 |
85.4 |
128.3 |
487 |
71 |
17.2 |
|
10000 |
4 |
14.9 |
84.6 |
118.6 |
410 |
67 |
17.9 |
|
S.E. of a treatment mean |
5 |
± 0.61 |
± 3.28 |
± 6.76 |
± 32.5 |
± 3.2 |
± 1.05 |
|
4 |
± 0.69 |
± 3.67 |
± 7.55 |
± 36.3 |
± 3.6 |
± 1.05 |
||
Females |
|
|||||||
0 |
5 |
12.5 |
78.3 |
91.7 |
349 |
48 |
|
|
2000 |
3 |
13.0 |
74.8 |
93.7 |
332 |
46 |
|
|
10000 |
3 |
13.3 |
77.3 |
96.0 |
349 |
51 |
|
|
S.E. of a treatment mean |
5 |
± 0.42 |
± 2.62 |
± 4.73 |
± 25.2 |
± 4.2 |
|
|
3 |
± 0.54 |
± 3.38 |
± 6.11 |
± 32.6 |
± 5.4 |
|
||
|
Organ/body weight ration (g/100 g body weight) |
|||||||
Male |
|
|||||||
0 |
5 |
|
0.57 |
0.85 |
3.02 |
0.45 |
0.11 |
|
2000 |
4 |
|
0.57 |
0.85 |
3.21 |
0.47 |
0.12 |
|
10000 |
4 |
|
0.57 |
0.80 |
2.75 |
0.45 |
0.12 |
|
S.E. of a treatment mean |
5 |
|
± 0.033 |
± 0.044 |
± 0.145 |
± 0.018 |
± 0.011 |
|
4 |
|
± 0.037 |
± 0.049 |
± 0.162 |
± 0.020 |
± 0.011 |
||
Females |
|
|||||||
0 |
5 |
|
0.61 |
0.73 |
2.77 |
0.38 |
|
|
2000 |
3 |
|
0.59 |
0.72 |
2.54 |
0.35 |
|
|
10000 |
3 |
|
0.59 |
0.72 |
2.63 |
0.38 |
|
|
S.E. of a treatment mean |
5 |
|
± 0.013 |
± 0.028 |
± 0.135 |
± 0.021 |
|
|
3 |
|
± 0.016 |
± 0.036 |
± 0.174 |
± 0.027 |
|
||
Applicant's summary and conclusion
- Conclusions:
- In conclusion, this experiment shows Ionox 330 produces no effects when fed to dogs for two years at dietary concentrations of up to 10,000 ppm.
- Executive summary:
lonox 330 was fed to dogs for two years at dietary concentrations of 0, 2,000 and 10,000 ppm. Observations were made on the health, behaviour and body weight of all animals. Blood samples were taken regularly for routine haematologica1 and clinical chemical examinations. Liver function tests were carried out at intervals on the control and top dose groups. At autopsy, major visceral organs were weighed and a histopathological examination made of all tissues.
The general health, behaviour and growth rate of the dogs remained unaffected throughout the experiment. No changes were observed in the organ weights and organ/body weight ratios, haematology and clinical chemistry of the animals.No lesion attributable to the exposure to lonox 330 was detected.
A dietary concentration of 10,000 ppm lonox 330 did not produce any toxicological effects when fed to dogs for two years.
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