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EC number: 205-201-9 | CAS number: 135-57-9
- 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
Not found to be hazardous by ingestion or in contact with skin
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Testing carried out in accordance to: OECD Guideline for testing of Chemicals (No. 401. Acute Oral Toxicity, Feb, 1987) State Environmental Protection Administration: The Guidelines for the Testing of Chemicals Ministry of Health, 2005: Technical Standards for testing of chemicals
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: State environmental protection administration: the guidelines for the testing of chemicals
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Ministry of health 2005: Technical standards for testing of chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- mouse
- Strain:
- other: NIH
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test species: Mice.
Strain: NIH.
Supplier: Guangdong Medical Laboratory Animal Center [certified animal number SCXK (Guangdong) 2008-0002].
Number of animals: 10 males and 10 females.
Number of groups: 2(test group and solvent control group).
Number of animal/group: 5 males and 5 females per group.
Body weight at the start of experiment: 22.4 ~ 32.3g .
Identification of animals: Tags marked with animal group number and treatment details were attached to cages. Each animal was given a unique number.
Acclimatization: Five days prior to the experiment in the test room.
Randomization: Animals were assigned to two groups.
Environmental conditions
Test Room: SPF animal lab in the Center
Animal house conditions: The test facility was an air-conditioned room with 12h artificial fluorescent light and 12h dark.
Temperature range: 20~25oC.
Humidity range: 40~70%.
Husbandry Practices
Caging: Stainless steel cages were used. Autoclaved clean dry corncob was used as the bedding material. Animals were housed in one group according to sex in cages.
Water bottle: Each cage was supplied with a polypropylene water bottle with a stainless steel nozzle.
Sanitation: Bedding material was changed daily.
Food and water: Standard pellet feed supplied by Guangdong Medical Laboratory Animal Center and ultra-pure filtered sterilized water were provided to the animals freely.
Frequency of providing feed and drinking water: Both drinking water and feed were provided ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Preparation of test substance: Known weights of the test substance were mixed with distilled water, and thereafter administered to groups of mice at the desired dose levels.
- Doses:
- Administration: All mice were fasted overnight prior to administration on of the test substance. The tested animals (5 males and 5 females each group) were given Pepton 22 ,which was dissolved in distilled water, by gavages at the dose of 5050 mg/kg and at the volume of 10ml/kg for once; Animals of solvent control group were given distilled water instead of tested compounds, with the same procedure as the test group.
Dose levels: A limit test at one dose level of 5050 mg/kg was carried out with mice (5 males and 5 females); the solvent control group was given distilled water instead of tested compounds was carried out with mice (5 males and 5 females) too. - No. of animals per sex per dose:
- Number of animals: 5 males and 5 females per group.
- Control animals:
- yes
- Details on study design:
- Acute oral toxicity of Pepton 22 was tested in two groups of mice. The tested animals (5 males and 5 females each group) were given Pepton 22 ,which was dissolved in distilled water, by gavages at the dose of 5050 mg/kg and at the volume of 10ml/kg for once; Animals of solvent control group were given distilled water instead of tested compounds, with the same procedure as the test group. Mice were observed for 14 days after the exposure. At the end of the test, all survivals were weighed and sacrificed, and necropsy were carried out. Body weight of the animals were recorded before and weekly after exposure.
Observation period: All animals were observed individually, daily for 14 days for various end-points of toxicity.
Body weight: Body weight of each animal was recorded just prior to administration of dose (0 day) and on day 7 and day 14 following the dosing.
Mortality: All animals were observed for mortality daily throughout the observation period.
Toxicity: All animals were observed for toxicity signs soon after dosing and once daily throughout the observation period until day 14 when the experiment was terminated.
Necropsy: Survivors were necropsied at the end of 14-day observation period for gross pathological examination. Autopsy was carried out in animals died during the observation period. - Preliminary study:
- Acute oral LD50 of Pepton 22 (supplied by Thomas Swan & Co. Ltd.) was greater than 5050 mg/kg both in female and male NIH mice.
Based on Globally Harmonized System of classification and Labelling of Chemicals (GHS), Pepton 22 was classified as category 5. Referring to “Acute oral, inhalation, dermal toxicity grading” of “The guidelines for the hazard evaluation of new chemical substance” (HJ/T 154-2004), State Environmental Protection Administration, Pepton 22 was “Actually Nontoxic”. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 050 mg/kg bw
- Mortality:
- Result of the acute oral toxicity test on Pepton 22, no mortality was observed in the treated group of mice throughout the observation period (Table 1).
- Clinical signs:
- other: In the dose level of 5050 mg/kg, all the animals were no abnormalities detected except slight inactivity. There was no mortality observed in mice treated with the test substance throughout the observation period.
- Gross pathology:
- No gross abnormalities were seen in the group of animals at necropsy at the end of 14-day observation period (Table 4).
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Data shows that material is not classified according to REGULATION (EC) No 1272/2008
Reference
Mortality Data and LD50
Table 1
Groups |
|
Female |
|
Male |
||
|
Animal number of each group |
Dead animals |
|
Animal number of each group |
Dead animals |
|
5050mg/kg |
|
5 |
0 |
|
5 |
0 |
solvent control |
|
5 |
0 |
|
5 |
0 |
LD50(95%CI) |
|
>5050mg/kg(not elicited) |
|
>5050mg/kg(not elicited ) |
Body weight
Table 2
Groups |
Gender |
No. |
0d |
7d |
14d |
|
weights |
weights |
weights |
||||
5050 mg/kg |
♀ |
1 |
23.9 |
23.9 |
28.3 |
|
4 |
26.0 |
27.0 |
34.1 |
|||
5 |
26.4 |
26.4 |
32.5 |
|||
6 |
24.6 |
26.0 |
33.0 |
|||
8 |
25.9 |
28.7 |
35.2 |
|||
♂ |
1 |
28.8 |
32.8 |
40.4 |
||
4 |
30.0 |
37.5 |
43.6 |
|||
7 |
30.1 |
34.1 |
41.7 |
|||
9 |
32.7 |
37.4 |
44.0 |
|||
10 |
29.2 |
34.6 |
39.7 |
|||
solvent control |
♀ |
2 |
26.2 |
27.4 |
32.3 |
|
3 |
25.3 |
28.4 |
34.0 |
|||
7 |
26.1 |
27.4 |
33.5 |
|||
9 |
22.4 |
23.7 |
29.7 |
|||
10 |
25.9 |
29.2 |
34.5 |
|||
♂ |
2 |
31.0 |
40.3 |
45.1 |
||
3 |
29.3 |
36.1 |
42.0 |
|||
5 |
29.2 |
34.0 |
39.8 |
|||
6 |
28.0 |
32.6 |
39.1 |
|||
8 |
32.3 |
39.2 |
46.3 |
|||
|
|
|||||
Table 3
Groups |
Gender |
0d |
7d |
14d |
5050mg/kg |
Female |
25.4±1.1(5) |
26.4±1.7(5) |
32.6±2.6(5) |
Male |
30.2±1.5(5) |
35.3±2.1(5) |
41.9±1.9(5) |
|
solvent control |
Female |
25.2±1.6(5) |
27.2±2.1(5) |
32.8±1.9(5) |
Male |
30.0±1.7(5) |
36.4±3.3(5) |
42.5±3.2(5) |
Gross pathology data
Table 4
Groups |
Gender |
No. |
Lesions |
Groups |
Gender |
No. |
Lesions |
5050mg/kg |
♀ |
1 |
NAD |
solvent control |
♀ |
2 |
NAD |
4 |
NAD |
3 |
NAD |
||||
5 |
NAD |
7 |
NAD |
||||
6 |
NAD |
9 |
NAD |
||||
8 |
NAD |
10 |
NAD |
||||
♂ |
1 |
NAD |
♂ |
2 |
NAD |
||
4 |
NAD |
3 |
NAD |
||||
7 |
NAD |
5 |
NAD |
||||
9 |
NAD |
6 |
NAD |
||||
10 |
NAD |
8 |
NAD |
NAD – no abnormalities detected
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 050 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Testing carried out in accordance to: OECD Guideline for Testing of Chemicals No. 402. Acute Dermal Toxicity, Feb. 1987 State Environmental Protection Administration : The Guidelines for the Testing of Chemicals Ministry of Health, 2005: Technical standards for testing of chemicals .
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: State Environmental Protection Administration : The Guidelines for the Testing of Chemicals
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Ministry of Health, 2005: Technical standards for testing of chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test species: Rats.
Strain: SD.
Supplier: Guangdong Medical Laboratory Animal Center [certified animal number SCXK (Guangdong) 2008-0002].
Number of animals: 10 males and 10 females.
Number of groups: 2(test group and solvent control group).
Number of animal/group: 5 males and 5 females per group.
Body weight at the start of experiment: 197 ~ 274g .
Identification of animals: Tags marked with animal group number and treatment details were attached to cages. Each animal was given a unique number.
Acclimatization: Five days prior to the experiment in the test room.
Randomization: Animals were assigned to two groups.
Environmental conditions
Test Room: SPF animal lab in the Center
Animal house conditions: The test facility was an air-conditioned room with 12h artificial fluorescent light and 12h dark.
Temperature range: 20~25oC.
Humidity range: 40~70%.
Husbandry Practices
Caging: Stainless steel cages were used. Autoclaved clean dry corncob was used as the bedding material. Animals were housed in one group according to sex in cages.
Water bottle: Each cage was supplied with a polypropylene water bottle with a stainless steel nozzle.
Sanitation: Bedding material was changed daily.
Food and water: Standard pellet feed supplied by Guangdong Medical Laboratory Animal Center and ultra-pure filtered sterilized water were provided to the animals freely.
Frequency of providing feed and drinking water: Both drinking water and feed were provided ad libitum. - Type of coverage:
- open
- Vehicle:
- water
- Details on dermal exposure:
- Test Procedure: An area of about 5×8 cm2 on the back of the animal was clipped free of hair. 24h later, the intact animals were selected to use. Pepton 22 was administered on the hair-free site of the rats. The rats were fasten in the stainless steel shelves for 24h, then the test site were cleaned with warm water. Animals of the test group were conducted in the 2500 mg/kg dose limit test, the solvent control group were given distilled water instead of tested compounds, with the same procedure as the test group.
- Control animals:
- yes
- Details on study design:
- Acute dermal toxicity of Pepton 22 (supplied by Thomas Swan & Co. Ltd.) was tested in two groups of Rats. Pepton 22 was administered on the hair-free site of the rats. The rats were fasten in the stainless steel shelves for 24h, then the test site were cleaned with warm water. Animals of the test group were conducted in the 2500 mg/kg dose limit test, the solvent control group were given distilled water instead of tested compounds, with the same procedure as the test group. Rats were observed for 14 days after the exposure. At the end of the test, all survivals were weighed and sacrificed, and necropsy were carried out. Body weight of the animals was recorded before and weekly after exposure.
- Preliminary study:
- Acute dermal LD50 of Pepton 22 (supplied by Thomas Swan & Co. Ltd.) was greater than 2500 mg/kg both in female and male SD rats.
Based on Based on Globally Harmonized System of classification and Labelling of Chemicals (GHS), Pepton 22 was classified as category 5. According to “Acute oral、inhalation、dermal toxicity grading” of “The guidelines for the hazard evaluation of new chemical substance” (HJ/T 154-2004), State Environmental Protection Administration, Pepton 22 was “Actually Nontoxic”. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Mortality:
- Result of the acute dermal toxicity test on Pepton 22, no mortality was observed in treated group of rats throughout the observation period (Table 1).
- Clinical signs:
- other: In the dose level of 2500 mg/kg, all the animals were no abnormalities detected except slight inactivity. There was no mortality observed in rats treated with the test substance throughout the observation period.
- Gross pathology:
- No gross abnormalities were seen in the group of animals at necropsy at the end of 14-day observation period (Table 4).
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Data shows that material is not classified according to REGULATION (EC) No 1272/2008
Reference
Mortality Data and LD50
Table 1
Groups |
|
Female |
|
Male |
|||||
|
Animal number of each group |
Dead animals |
|
Animal number of each group |
Dead animals |
||||
2500mg/kg |
|
5 |
0 |
|
5 |
0 |
|
||
solvent control |
|
5 |
0 |
|
5 |
0 |
|
||
LD50(95%CI) |
|
>2500mg/kg(not elicited) |
|
>2500mg/kg(not elicited ) |
|
||||
Body weight
Table 2
Groups |
Gender |
No. |
0d |
7d |
14d |
weights |
weights |
weights |
|||
2500 mg/kg |
♀ |
1 |
203 |
235 |
254 |
3 |
197 |
218 |
238 |
||
7 |
214 |
234 |
262 |
||
8 |
211 |
229 |
254 |
||
12 |
204 |
231 |
250 |
||
♂ |
2 |
257 |
292 |
337 |
|
3 |
270 |
309 |
347 |
||
4 |
267 |
300 |
347 |
||
7 |
257 |
306 |
344 |
||
12 |
241 |
284 |
330 |
||
solvent control |
♀ |
2 |
201 |
221 |
239 |
4 |
207 |
233 |
258 |
||
5 |
207 |
231 |
265 |
||
9 |
202 |
202 |
246 |
||
10 |
224 |
245 |
273 |
||
♂ |
1 |
265 |
313 |
346 |
|
5 |
274 |
318 |
368 |
||
8 |
262 |
315 |
359 |
||
9 |
252 |
306 |
362 |
||
10 |
255 |
297 |
353 |
Table 3
Groups |
Gender |
0d |
7d |
14d |
2500mg/kg |
Female |
205.8±6.8 (5) |
229.4±6.8 (5) |
251.6±8.8 (5) |
Male |
258.4±11.3 (5) |
298.2±10.2 (5) |
341.0±7.4 (5) |
|
solvent control |
Female |
208.2±9.2 (5) |
226.4±16.1 (5) |
256.2±13.8 (5) |
Male |
261.6±8.7 (5) |
309.8±8.4 (5) |
357.6±8.4 (5) |
Gross pathology data
Table 4
Groups |
Gender |
No. |
Lesions |
Groups |
Gender |
No. |
Lesions |
2500 mg/kg |
♀ |
1 |
NAD |
solvent control |
♀ |
2 |
NAD |
4 |
NAD |
3 |
NAD |
||||
5 |
NAD |
7 |
NAD |
||||
6 |
NAD |
9 |
NAD |
||||
8 |
NAD |
10 |
NAD |
||||
♂ |
1 |
NAD |
♂ |
2 |
NAD |
||
4 |
NAD |
3 |
NAD |
||||
7 |
NAD |
5 |
NAD |
||||
9 |
NAD |
6 |
NAD |
||||
10 |
NAD |
8 |
NAD |
NAD – no abnormalities detected
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 500 mg/kg bw
Additional information
Justification for classification or non-classification
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.