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EC number: 416-600-4 | 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
HAT ISO was tested for acute toxicity by oral and dermal application in fixed dose studies in the rat. These studies showed a LD50 > 2000 mg/kg bw in both application routes. A study for investigating the toxicity by inhalation was waived, as the risk of exposure to HAT ISO by the inhalation route is not likely. For more details on exposure assessment see risk assessment report in section 13.
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:
- 1993-07-09 to 1993-11-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- EC 92/69
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Analytical purity: >= 99.65 %
Lot/batch No.: 93.166; - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Crédo: B.P. 0109; 69592 L'Arbresle Cedex - France;
- Age at study initiation: adult 5 to 7 weeks old;
- Weight at study initiation: males: 130 to 230 g; females: 120 to 180 g;
- Fasting period before study: over night (15 to 20 hours) before treatment;
- Housing: in groups of 5 (2 for preliminary study) of same sex and dosing group in polycarbonate cages type FI (preliminary study) or type MI (main study)
- Diet: ad libitum; pelleted complete diet; rat-mouse diet reference AO4 C10; supplier: Usine d'Alimentation Rationelle, Villemoisson s/Orge, France;
- Water: ad libitum; filtered (0.2 µm) mains drinking water;
- Acclimation period: 5 days minimum between arrival of animals and start of treatment;
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70 R.H.
- Air changes (per hr): min. 8;
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- The test article was administered once only as a 10 % (w/v) suspension in a 1 % aqueous dispersion of carboxymethylcellulose and at the dose levels of 2000 mg/kg; by the oral route (gavage) in the Sprague-Dawley rat (5 males + 5 females);
- Doses:
- males: 2000 mg/kg bw;
females: 2000 mg/kg bw; - No. of animals per sex per dose:
- 5 males;
5 females; - Details on study design:
- The test article was administered once only as a 10 % (w/v) suspension in a 1 % aqueous dispersion of carboxymethylcellulose and at the dose levels of 2000 mg/kg; by the oral route (gavage) in the Sprague-Dawley rat (5 males + 5 females).
Examinations for mortality and abnormal clinical signs were performed 15 minutes after intubation, then at 1, 2 and 4 hours, and then daily for the 14 day study period.
All the animals were weighed the day before treatment (Day-1), immediately before administration of the test article (Day 1), on Days 8 and 15.
A necropsy was performed for all the animals after the final in vivo observation on Day 15. - Statistics:
- LD50 deviation
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: None visible.
- Gross pathology:
- Effects on organs: No macroscopically detectable abnormality was noted.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- HAT ISO was tested for acute oral toxicity in a fixed dose study in the rat. The LD50 for male and female rats was found to be > 2000 mg/kg bw. No classification and labelling is necessary according to Regulation 1272/2008/EC (CLP).
- Executive summary:
HAT ISO was tested for acute oral toxicity in a fixed dose study in the rat. The LD50 for male and female rats was found to be > 2000 mg/kg bw.
Under the conditions of the applied test, HAT ISO can be regarded as practically non-toxic.
Reference
MORTALITY:
Dose Level Mg/ |
Sex |
Cumulative Mortality |
TOTAL MORTALITY % |
|||||||||||||||||
DAY 1 |
DAY |
|||||||||||||||||||
1/4 |
1 |
2 |
4 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
|||
Hours |
|
|||||||||||||||||||
2000 |
M |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
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
- Study period:
- 1993-07-09 to 1993-10-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- EC92/69
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Analytical purity: >= 99.65 %
Lot/batch No.: 93.166; - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Crédo, B.P. 0109; 69592 L'Arbresle Cedex - France;
- Age at study initiation: adult 5 to 7 weeks old;
- Weight at study initiation: 200 to 300 g;
- Fasting period before study: no
- Housing: individually in polycarbonate cages type FI;
- Diet: ad libitum; pelleted complete rat-mouse diet, reference AO4 C10; Usine d'Alimentation Rationelle, Villemoisson s/Orge, France;
- Water: ad libitum, filtered (0.2 µm) drinking water;
- Acclimation period: 5 days minimum between animal arrival and start of treatment;
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25;
- Humidity (%): 30 to 70 R.H.
- Air changes (per hr): min. 8;
- Photoperiod (hrs dark / hrs light): 12 / 12; - Type of coverage:
- semiocclusive
- Vehicle:
- other: Aqueous dispersion of 1 % carboxymethylcellulose
- Details on dermal exposure:
- Preparation of animals:
The day before the application of the test article, the back and the flanks of each animal will be carefully clipped, to expose an area of the skin which should not be less than 10 % of the total body surface. At the time of the application, only those animals showing a perfectly healthy skin and no sign of macroscopic irritation will be kept for the test.
Application of the test article:
The test article was applied, once only as a 58.47 % (W/V) paste in a 1 % aqueous dispersion of carboxymethylcellulose and at the dose level of 2000 mg/kg by the cutaneous route. - Duration of exposure:
- 24 h
- Doses:
- males: 2000 mg/kg bw;
females. 2000 mg/kg bw; - No. of animals per sex per dose:
- 5 males; 5 females;
- Control animals:
- no
- Details on study design:
- The test article was applied, once only as a 58.47 % (w/v) paste in a 1 % aqueous dispersion of carboxymethylcellulose and at the dose level of 2000 mg/kg, by the cutaneous route in the Sprague Dawley rat (5 males and 5 females).
Examinations for mortality and abnormal clinical signs were performed 15 minutes after application, then at 1, 2 and 4 hours, and then daily for the 14 day study period.
Cutaneous examinations were performed from day 2 to 15.
All animals were weighed, immediately before application of the test article (Day 1), on Day 8 and 15.
A necropsy was performed for all the animals after the final in vivo observation on Day 15. - Statistics:
- LD50 deviation
- Preliminary study:
- No preliminary study was performed
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: There were no changes in behaviour or clinical signs in any of the treated animals during the observation period.
- Gross pathology:
- There were no macroscopic findings that could be associated with treatment.
- Other findings:
- Cutaneous examinations:
The local tolerance of the test article was good: no cutaneous lesion (erythema or oedema) was noted to the application site of the test article during the observation period - Interpretation of results:
- GHS criteria not met
- Conclusions:
- HAT ISO was tested for acute dermal toxicity in a fixed dose study in the rat. The LD50 for male and female rats was found to be > 2000 mg/kg bw. No classification and labelling is necessary according to Regulation 1272/2008/EC (CLP).
- Executive summary:
HAT ISO was tested for acute dermal toxicity in a fixed dose study in the rat. The LD50 for male and female rats was found to be > 2000 mg/kg bw.
Under the conditions of the applied test, HAT ISO can be regarded as practically non-toxic.
Reference
MORTALITY:
Dose Level Mg/ |
Sex |
Cumulative Mortality |
TOTAL MORTALITY % |
|||||||||||||||||
DAY 1 |
DAY |
|||||||||||||||||||
1/4 |
1 |
2 |
4 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
|||
Hours |
|
|||||||||||||||||||
2000 |
M |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
HAT ISO was tested for acute oral toxicity in a fixed dose study in the rat according to EU Method B.1 / OECD Guideline 401.
The LD50 for male and female rats was found to be > 2000 mg/kg bw.
Under the conditions of the applied test, HAT ISO can be regarded as practically non-toxic.
HAT ISO was tested for acute dermal toxicity in a fixed dose study in the rat according to EU Method B.3 / OECD Guideline 402.
The LD50 for male and female rats was found to be > 2000 mg/kg bw.
Under the conditions of the applied test, HAT ISO can be regarded as practically non-toxic.
The testing of acute toxicity by inhalation was waived. Due to the risk assessment report of HAT ISO, exposure by the inhalation route is not likely.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on acute toxicity, the test item does not require classification
according to Regulation (EC) No 1272/2008 (CLP), as amended for the
tenth time in Regulation (EU) No 2017/776.
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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