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EC number: 807-448-3 | 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
Endpoint summary
Administrative data
Description of key information
The acute, oral toxicity of the test material was assessed in accordance with OECD Guideline 401. The acute oral median lethal dose (LD5O) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. As such, the test material does not meet the criteria for classification.
The acute, dermal toxicity of the test material was assessed in accordance with OECD Guideline 402. The acute dermal median lethal dose (LDSo) of the test material in the Sprague- Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. As such, the test material does not meet the criteria for classification.
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:
- 12 November 2013 to 05 December 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: US Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Australian Guideline
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River (UK) Ltd., Margate, Kent, UK.
- Weight: Start of the main study the males weighed 158 to 188g, and the females 139 to 175g
- Age at study initiation: 5 to 8 weeks
- Weight at study initiation: 193.4 to 213.7g
- Fasting period before study: Overnight
- Housing: groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK)” was allowed throughout the study
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-24 °C
- Humidity (%): 48-66%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 females+ 5 males
- Control animals:
- no
- Details on study design:
- The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- No statistical analysis was performed.
- Preliminary study:
- A preliminary study was performed in a single animal at 2000 mg/kg body weight.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No intercurrent deaths occured during the course of the study.
- Clinical signs:
- No signs of systemic toxicity were noted during the study.
- Body weight:
- All animals showed expected bodyweight gain during the study.
- Gross pathology:
- No abnormalities were recorded at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute, oral toxicity of the test material was assessed in accordance with OCED Guideline 401. The acute oral median lethal dose (LD50) of the test material, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. As such, the test material does not meet the GHS criteria for classification.
- Executive summary:
Guideline
A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" (adopted 24 February 1987) and Method B1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). The method also complies with the requirements of US Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA) and Australian Toxicology Guidelines.
Method
Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material as a solution in arachis oil B.P. at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.
Results
There were no deaths. No signs of systemic toxicity were noted during the study.
All animals showed expected bodyweight gain during the study.
No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD5O) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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:
- 20 July and 3 August 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Australian Guidelines
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent
- Age at study initiation: approximatively 12 Weeks
- Weight at study initiation: Males 233 to 257 g, Females 205 to 227 g
- After a minimum acclimatisation period of five days the animals were selected at random and given a number unique within the study by
indelible ink-marking on the tail and a number written on a cage card.
- Housing: in suspended polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet (e.g. ad libitum): Teklad Rat-Mouse Rodent Diet. ad libitum
- Water (e.g. ad libitum):ad libitum
- Environement: animal room was maintained at a temperature of 19 to 25 C and relative humidity of 50 to 60%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): >30 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours continuous light/dark cycle
IN-LIFE DATES: 12 November 2013 to 03 December 2013 - Type of coverage:
- semiocclusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: ca. 10%
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage
(HYPERTIE). The bandage was further secured with a piece of BLENDERM wrapped around each end.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil B.P. to remove any residual test material
- Time after start of exposure: 24 h
- Duration of exposure:
- 24 h
- Doses:
- Single dose level of 2000 mg/kg bodywight
- No. of animals per sex per dose:
- 5m, 5f, dosed at 2000 mg/kg bw
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: gross pathological examination, behaviour or clinical signs, body weight, dermal reaction - Statistics:
- No statistical analysis was performed.
- Preliminary study:
- not applicable.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No intercurrent deaths occured during the course of the study.
- Clinical signs:
- No signs of systemic toxicity were noted during the study.
- Body weight:
- All animals showed expected bodyweight gain during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Very slight or well-defined erythema was noted at the treatment sites of the female animals on removal of the patches and persisted for 3 or 4 days after treatment. Crust formation was evident at one treatment site 3 and 4 days after treatment. All treatment sites appeared normal 5 days after treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute, dermal toxicity of the test material was assessed in accordance with OECD Guideline 402. The median lethal dose of the test material after single dermal application to rats of both sexes, is greater than 2000 mg/kg body weight. As such, the test material does not meet the GHS criteria for classification.
- Executive summary:
Guideline
A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method followed that described in the OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 February 1987) and Method 83 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). The method also complies with the requirement of US Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA) and Australian Toxicology Guidelines.
Method
A group of ten animals (five males and five females) was given a single 24-hour, semioccluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then
killed for gross pathological examination.
Results
There were no deaths. No signs of systemic toxicity were noted during the study. Signs of irritation noted in the female animals were very slight to well-defined erythema with crust formation evident at one treatment site.
All animals showed expected bodyweight gain during the study.
No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test material in the Sprague- Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
The key acute toxicity studies were performed on the read-across substance Ethylene glycol, reaction products with polyisobutenyl succinic anhydride and hexadecenyl succinic anhydride, salts with dimethylethanolamine. The justification for read-across is attached in Section 13 of the IUCLID.
Oral
A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" (adopted 24 February 1987) and Method B1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). The method also complies with the requirements of US Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA) and Australian Toxicology Guidelines.
Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material as a solution in arachis oil B.P. at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.
There were no deaths. No signs of systemic toxicity were noted during the study.
All animals showed expected bodyweight gain during the study.
No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD5O) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Dermal
A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method followed that described in the OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24
February 1987) and Method 83 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). The method also complies with the requirement of US Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA) and Australian Toxicology Guidelines.
A group of ten animals (five males and five females) was given a single 24-hour, semioccluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then
killed for gross pathological examination.
There were no deaths. No signs of systemic toxicity were noted during the study. Signs of irritation noted in the female animals were very slight to well-defined erythema with crust formation evident at one treatment site.
All animals showed expected bodyweight gain during the study.
No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LDSo) of the test material in the Sprague- Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Justification for classification or non-classification
In accordance with the CLP Regulation, No 1272/2008, classification is required for acute oral toxicity and acute dermal toxicity if the LD50 values are less than or equal to 2000 mg/kg bw. The acute, oral LD50 value was determined to be >2000 mg/kg and the median lethal dose, LDSo, for acute, dermal toxicity was determined to be >2000 mg/kg. Therefore, as the data of the surrogate substance showed no evidence of acute toxicity by either the oral or dermal route, the reference substance does not meet the criteria for classification.
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