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EC number: 617-638-6 | CAS number: 84868-02-0
- 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
No mortality was observed in the limit test. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg (reference 7.2-1).
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:
- 09-04-1991 to 11-06-1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- OECD 1981, Updated Guideline adopted February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Wistar Chbb: THOM
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species: Rat, Wistar Chbb: THOM,
- Sex: males (m) and females (f)
- Age at study initiation: about 7 to 9 weeks
- Source: Thomae, BiberachTEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Mean weight at study initiation: 187 (167 - 205) g
- Fasting period before study: 17 hours prior to dosing until 4 hours after treatment
- Housing: Makrolon cages type III (floor area: 37.5 x 21 cm - 787.5 cm2, height: 15 cm) on mobile racks
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 27
- Humidity (%): 37 - 44
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- other: via stomach tube
- Vehicle:
- other: 0.25 % aqueous Methocel K 4M Premium solution
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
DOSAGE PREPARATION: 10 g substance mixed in 100 mL vehicle - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex - 10 animals in total
- Control animals:
- yes
- Remarks:
- 10 animals - 5 aniamls per sex
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
observations - for 4 -6 hours after administration and then daily;
weighing - before treatment and on days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, gross pathological investigation - Statistics:
- The body weight data were processed by means of the program TOX 511 A.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All the rats survived the observation period.
- Clinical signs:
- other: No clinical symptoms were observed after treatment. Only pale feces were seen on day 2 of the study.
- Gross pathology:
- In the rats, which were all sacrificed at the end of the observation period, no organ alterations were seen.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No mortality was observed in the limit test. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test item following a single oral administration to the Wistar (Chbb: THOM) male and female rats. The test was performed according to OECD 401 "Acute Oral Toxicity" (1987). A limit test with a dose of 2000 mg/kg bw was performed. 5 male and 5 female rats were treated with the limit dose of 200 mg/kg bw. 5 male and 5 female rats were treated with the vehicle as control group. The test item was administered orally via stomach tube, diluted in 0.25 % aqueous Methocel K 4M Premium solution. The animals were observed 4 – 6 hours after administration and then daily for 15 days. Bodyweights were recorded before treatment and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period all animals were anesthetized with CO2 and subjected to complete gross pathology. There were no deaths during the study. No clinical symptoms were observed after treatment. Only pale feces were seen on day 2 of the study. Body weight development of treated and control rats was normal. In the rats, which were all sacrificed at the end of the observation period, no organ alterations were seen. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg.
Reference
Median lethal dose (LD50)
Sex |
LD50 in mg/kg on days 1+8+15 |
male |
> 2000 |
female |
> 2000 |
The limit test (2000 mg/kg) showed no mortality, and thus there was no need for a LD50 determination and calculation.
Body weight
Body weight |
||||||||||
Dose mg/kg |
Sex |
Animal No. |
Values in grams on Day |
|||||||
1 |
2 |
4 |
6 |
8 |
11 |
13 |
15 |
|||
2000 |
Male |
11 |
167 |
179 |
191 |
212 |
224 |
243 |
252 |
258 |
Male |
12 |
170 |
189 |
200 |
214 |
225 |
253 |
260 |
267 |
|
Male |
13 |
167 |
180 |
199 |
216 |
223 |
248 |
256 |
266 |
|
Male |
14 |
174 |
190 |
204 |
220 |
230 |
256 |
267 |
277 |
|
Male |
15 |
180 |
191 |
216 |
234 |
251 |
276 |
283 |
283 |
|
Female |
16 |
175 |
187 |
194 |
195 |
201 |
206 |
213 |
214 |
|
Female |
17 |
181 |
193 |
204 |
213 |
217 |
229 |
228 |
239 |
|
Female |
18 |
169 |
180 |
188 |
186 |
193 |
197 |
202 |
198 |
|
Female |
19 |
181 |
191 |
199 |
206 |
206 |
212 |
220 |
217 |
|
Female |
20 |
183 |
196 |
208 |
215 |
217 |
232 |
228 |
236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Males |
Number |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
Mean |
172 |
186 |
202 |
219 |
231 |
255 |
264 |
270 |
|
|
Gain % |
**** |
8 |
9 |
8 |
5 |
10 |
4 |
2 |
|
|
Females |
Number |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
Mean |
178 |
189 |
199 |
203 |
207 |
215 |
218 |
221 |
|
|
Gain % |
**** |
6 |
5 |
2 |
2 |
4 |
1 |
1 |
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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
OECD 401
A study was performed to assess the acute oral toxicity of the test item following a single oral administration to the Wistar (Chbb: THOM) male and female rats. The test was performed according to OECD 401 "Acute Oral Toxicity" (1987). A limit test with a dose of 2000 mg/kg bw was performed. 5 male and 5 female rats were treated with the limit dose of 200 mg/kg bw. 5 male and 5 female rats were treated with the vehicle as control group. The test item was administered orally via stomach tube, diluted in 0.25 % aqueous Methocel K 4M Premium solution. The animals were observed 4 – 6 hours after administration and then daily for 15 days. Bodyweights were recorded before treatment and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period all animals were anesthetized with CO2 and subjected to complete gross pathology. There were no deaths during the study. No clinical symptoms were observed after treatment. Only pale feces were seen on day 2 of the study. Body weight development of treated and control rats was normal. In the rats, which were all sacrificed at the end of the observation period, no organ alterations were seen. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg (reference 7.2-1).
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. The LD50 was greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.
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