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EC number: 282-438-4 | CAS number: 84204-70-6
- 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
Acute oral toxicity: LD50 male/female: 2717 mg/Kg bw
Acute dermal toxicity: LD50 male/female: > 2000 mg/Kg bw
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 the 30th March to the 2th of May, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to internationally accepted guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
Acclimatization March 30 to April 5, 1990
Observation April 6 to May 2, 1990
Source: BRL, Biological Research Laboratories Ltd, Wolferstrasse 4, CH-4414 Fullinsdorf
Mumber of animals 5 males per group 5 females
Total number of animals 20 males, 20 females
Age at start of treatment males: 9 to 10 weeks, females: 11 to 12 weeks
Body weight at start males: 200 — 290 g of treatment females: 178 — 211 g
Identification: By unique cage number and corresponding color—coded spots on the tail.
Randomization: Randomly selected at time of delivery in groups of five.
Acclimatization: One week under laboratory conditions, after veterinary examination.
HUSBANDRY
Room No.: 136
Standard Laboratory Conditions:
Air-conditioned with 10—13 air changes per hour, and hourly monitored environment with temperature 20±3 °C, relative humidity 40-70 %, 12 hours artificial fluorescent light/12 hours dark, music/light period.
Accommodation: groups of five in Nakrolon type-3 cages with standard softwood bedding (‘Lignocel’, Schill AG, CH—4132 Muttenz).
Diet: pelleted standard Kliba 343, Batches 67/90 and 68/90 rat maintenance diet (‘Kliba’, Klingentalmuehle AG, CH—4303 Kaiseraugst) available ad libUtum.
Analysis for contaminants performed.
Water: community tap water from Itingen, available ad libitum. Analyses for contaminants performed. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The animals received a single dose of the test article on a mg/kg body weight base by oral gavage after being fasted for 12 to 18 hours (access to water was not interrupted). Food was again presented approximately 3 hours after dosing.
The oral administration was used because this is one possible route of human exposure during manufacture, handling and use of the test article. - Doses:
- 10 ml at 1000 mg/kg
10 ml at 2000 mg/kg
20 ml at 3500 mg/kg
20 ml at 5000 mg/kg - No. of animals per sex per dose:
- 5 male
5 female - Control animals:
- no
- Details on study design:
- OBSERVATION
Mortality, Viability: Four times during test day 1, and daily during days 2 - 15.
Body Weights: Test days 1 (pre—administration), 8 and 15.
Clinical Signs: Each animal was examined for changes in appearance and behaviour rour times during day 1, and daily during days 2-15. All abnormalities were recorded: General behaviour, Respiration, Eye, Nose, Motility, Body Posture, Motor Susceptibility, Skin, Various.
PATHOLOGY
Necropsies were perrormed by experienced prosectors.
All animals were necropsied.
All animals surviving to the end o the observation period were killed by intra peritoneal injection of sodium pentobarbitone. - Statistics:
- The LOGIT—Model (COX, Analysis of Binary Data, London 1977) was applied to estimate the toxicity value. Additionally, the 90, 95 and 99 % conridence
limits for the toxicity ftr each sex and the slope of the dose response line were estimated. - Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- 2 717 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 984 - <= 3 719
- Sex:
- male
- Dose descriptor:
- approximate LD50
- Effect level:
- 2 432 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 642 - <= 3 602
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- 2 655 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 785 - <= 8 973
- Mortality:
- The following death rate was observed:
0% at 1000 mg/kg
20 % at 2000 mg/kg
100 % at 3500 mg/kg
80 % at 5000 mg/kg
the LOGIT-ESTIMATION for the acute oral toxicity of in rats of bot6 sexes observed for a period of 15 days is 2717 mg/kg.
For Males: 2432 mg/kg
For Females: 2655 mg/kg
WITH A 95 % CONFIDENCE LIMITS OF:
males/females: 1984- 3719 mg/kg
males 1642 - 3602 mg/kg
females 785 - 8973 mg/kg - Clinical signs:
- other: The following clinical signs were observed: 1000 mg/kg: males/females - diarrhea; no clinical signs noted. The animals showed diarrhea only on day 1 (from hour 5). Afterwards they had no changes in behaviour and appearence during the whole observation per
- Gross pathology:
- The following macroscopical organ rindings were observed:
1000 mg/kg sacrificed, no macroscopical findings noted
2000 mg/kg: sacrificed, no macroscopical rindings noted
2000 mg/kg: dead lungs: not collapsed, reddened .
3500 mg/kg: dead, general observations: emaciated
stomach : contents black—brown
duodenum: contents black—brown
jejunum : contents black—brown
ileum : contents black—brown
caecum : contents black—brown
colon : contents black—brown
general observations: discoloration yellowish.
5000 mg/kg: sacrificed, lungs: discoloration, dark red
5000 mg/kg: dead, general observations: discoloration yellowish - Interpretation of results:
- not classified
- Remarks:
- Migrated information according to CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 oral toxicity of the substance in rats of both sexes observed for a period of 15 days is:
2717 mg/kg
For Males: 2432 mg/kg
For Females: 2655 mg/kg - Executive summary:
Materials and method
The acute oral toxicity was determinated in the substance according to the OECD Guideline 401 (Acute Oral Toxicity) and EU Method B.1 (Acute Toxicity (Oral), in GLP.
The test article was administered to rats of both sexes by oral gavage at single doses from 1000 to 5000 mg/kg.
Observation:
The following death rate was observed:
0 % at 1000 mg/kg
20 % at 2000 mg/kg
100 % at 3500 mg/kg
80 % at 5000 mg/kg
Results
the LOGIT-estimation for the acute oral toxicity of in rats of both sexes observed for a period of 15 days is 2717 mg/kg (LD50).
(Males: 2432 mg/kg-Females: 2655 mg/kg). Several recovered clinical signs were observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 717 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is performed on the substance itself, according to the OECD and UE Guideline, in GLP.
Additional information
Acute Oral Toxicity
The acute oral toxicity was determinated in the substance according to the OECD Guideline 401 (Acute Oral Toxicity) and EU Method B.1 (Acute Toxicity (Oral), in GLP.
The test article was administered to rats of both sexes by oral gavage at single doses from 1000 to 5000 mg/kg.
Several recovered clinical signs were observed. The LD50 oral toxicity in rats of both sexes observed for a period of 15 days was 2717 mg/kg.
Acute Dermal Toxicity
The acute dermal toxicity was determinated in the substance according to the OECD Guideline 402 (Acute Dermal Toxicity) and EU Method B.3 (Acute Toxicity (Dermal), in GLP.
The test article was applied to the skin of rats of both sexes for 24 hours at a single dose of 2000mg/kg.
No death was observed at 2000 mg/kg, animals had recovered until termination of the study. No systemic symptoms were observed in the animals throughout the study. Males/females were sacrificed, no macroscopical findings noted.
The LD50 was defined > 2000 mg/L.
Justification for classification or non-classification
Acute oral toxicity
According to the CLP Regulation 1272/2008/EC, 3.1.2.1 section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1:
Oral (mg/kg body weight)
Category 1: LD50 ≤ 5
Category 2: 5 <LD50 ≤ 50
Category 3: 50 < LD50 ≤ 300
Category 4: 300 < LD50 ≤ 2 000
The oral LD50 value of substance in Wistar rats was 2717 mg/kg/body weight.
The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.
Acute dermal toxicity
According to the CLP Regulation 1272/2008/EC, 3.1.2.1 section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1:
Dermal (mg/kg body weight)
Category 1: LD50 ≤ 50
Category 2: 5 <LD50 ≤ 200
Category 3: 50 < LD50 ≤ 1000
Category 4: 300 < LD50 ≤ 2 000
The oral LD50 value of substance in Wistar rats was > 2000 mg/kg/body weight.
The substance is not classified for dermal toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.
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