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EC number: 429-460-4 | CAS number: 7078-98-0
- 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
Acute Oral Toxicity: The LD50 is greater than 5000 mg/kg.
Acute Dermal Toxicity: The LD50 is greater than 2000 mg/kg.
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: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animals were received from Ace Animals, Boyertown, PA.
- Age at study initiation: Approximately four to twelve weeks.
- Weight at study initiation: 220 - 299 grams for male and 224 - 268 grams for females.
- Fasting period before study: 16-20 hours prior to dosing.
- Housing: The animals were housed 5/sex/cage in suspended wire cages.
- Diet (e.g. ad libitum): Fresh Purina Rat Chow was freely avaiable (except during fasting period).
- Water (e.g. ad libitum): Water was freely available at all times.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The animal room was temperatue controlled.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle. - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE:
Corn oil
DOSAGE PREPARATION:
The test article was ground with a mortar and pestle. 15 g was mixed with corn oil to a total volume of 30 ml and dosed from a stir plate. The dose was based on the dry weight of the test article. A single dose was administered orally by syringe and dosing needle. - Doses:
- 5000 mg/kg bw and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex per dose.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1, 2 and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects.
The animals were observed twice daily for mortality. Body weights were recorded immediately pretest, on days 3 and 7, at death or at termination in the survivors.
- Necropsy of survivors performed: yes, all animals were examined for gross pathology. - Statistics:
- An estimate of the LD50 was made based on the results.
- Preliminary study:
- Not applicable.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One male rat from the high dose group (5000 mg/kg) died on day 3 and one from the 2000 mg/kg dose group died on day 2.
- Clinical signs:
- other: 5000 mg/kg: One male died on day 3 with predeath physical signs of diarrhea, chromodacryorrhea, soiling of the anogenital area, piloerection, lethargy, flaccid muscle tone, brown staining of the nose/mouth area and wetness of the anogenital area. Physica
- Gross pathology:
- Necropsy of the animal that died at the 5000 mg/kg level revealed abnormalities of the thymus, lungs, liver, kidneys, spleen and gastrointestinal tract, as well as soiling and wetness of the anogenital area. Necropsy results of survivors were normal in 2/9 animals dosed at 5000 mg/kg.
Localized alopecia was noted in the remaining seven animals.
All animals dosed at 2000 mg/kg appeared normal at necropsy.
No necropsy was performed on the animal that died at the 2000 mg/kg level since it was cannibalized. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 is greater than 5000 mg/kg.
- Executive summary:
Objective:
To determine the potential for toxicity of the test article when administered orally to rats. This study was designed to comply with the standards set forth by:
EC Official Joumal of the European Communities. L 383 A Part B, Method B.l. Acute Oral Toxicity 12/29/92.
OECD Guidelines for Testing of Chemicals, No. 401, Acute Oral Toxicity, adopted 2/24/87.
Method:
Five healthy male and five healthy female Wistar albino rats were dosed orally with the test substance at 5000 mg/kg of body weight. Since test article related mortality occurred at this level, an additional group of five male and five females were dosed at 2000 mg/kg of body weight. The rats were observed 1,2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects. The animals were observed twice daily for mortality. Body weights were recorded immediately pretest, on days 3 and 7, at death or at tennination in the survivors. All animals were examined for gross pathology.
Results:
5000 mg/kg: Nine of ten animals survived the 5000 mg/kg oral dose. One male died on day 3 with predeath physical signs of diarrhea, chromodacryonliea, soiling of the anogenital area, piloerection, lethargy, flaccid muscle tone, brown staining of the nose/mouth area and wetness of the anogenital area. Necropsy revealed abnonnalities of the thymus, lungs, liver, kidneys, spleen and gastrointestinal tract, as well as soiling and wetness of the anogenital area. Physical signs noted in survivors included diarrhea, soiling of the anogenital area, lethargy, bloated abdomen, piloerection, wetness of body areas, brown staining of the nose/mouth area and localized alopecia. Body weight changes were nonnal in 7/9 survivors. Two males lost weight by day 3 but gained normally by day 7. Necropsy results of survivors were normal in 2/9 animals. Localized alopecia was noted in 7/9 animals.
2000 mg/kg: Nine of ten animals survived the 2000 mg/kg oral dose. One male died on day 2 with predeath physical signs of lethargy, dyspnea and soiling of the anogenital area. A necropsy was not performed since the animal was cannibalized. Physical signs of diarrhea, soiling of the anogenital area, lethargy, brown staining of the nose/mouth area and wetness of the anogenital area were noted in survivors. Body weight changes were normal in 8/9 survivors. One female lost weight during the second week of the observation period. Necropsy results of survivors were normal.
Conclusion:
The LD50 is greater than 5000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 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:
- Experimental start date (1st exposure to test substance): 2nd March 1998. Experimental termination date (last date data collected): 16th March 1998.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
- 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:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animals were received from Ace Animals, Boyertown, PA.
- Age at study initiation: Approx 8 to 12 weeks.
- Weight at study initiation: Pretest body weight range was 2.1-2.7 kg for males and 2.0-2.4 kg for females.
- Fasting period before study: None, food was provided daily.
- Housing: Animals were housed 1 per cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow was provided daily.
- Water (e.g. ad libitum): Water was freely available at all times.
- Acclimation period: At least one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Animal room was temperature controlled.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle.
IN-LIFE DATES: From: Day 1 To: Day 14 - Type of coverage:
- semiocclusive
- Vehicle:
- other: test artilcel moistened with 1.5 ml of saline.
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 24 hours prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair.
- % coverage: The prepared site was approximately 10% of the body surface.
- Type of wrap if used: The test article was applied under a 4 layered surgical gauze patch approximately 10 x 15 cm. The patch and test article were moistened with 1.5 ml of saline to enhance contact of the test article with the dose site. Gentle pressure was applied to the gauze to aid in the
distribution of the test substance over the prepared site. The torso was wrapped with plastic which was secured with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was gently wiped from the treated site prior to dermal observations.
- Time after start of exposure: The test article remained in contact with the skin for 24 hours at which time the wrappings were removed.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A single dose of the test article was applied to the prepared site at a dose level of 2000 mg/kg.
VEHICLE
The test article was moistened with 1.5 ml of saline to enhance contact of the test article with the dose site. - Duration of exposure:
- 24 hour contact period.
- Doses:
- Single dose level of 2000 mg/kg (dose was based on dry weight).
- No. of animals per sex per dose:
- 5 males and 5 females.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: The animals were observed 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects. The animals were observed twice daily for 14 days for mortality.
Body weights were recorded pretest and on days 3, 7 and 14 or at death.
- Necropsy of survivors performed: yes, all animals were examined for gross pathology.
- Other examinations performed:
The test sites were scored for dermal initation at 30 to 60 minutes post patch removal and again at 24, 48 and 72 hours post patch removal and on days 5, 7, 10 and 14 using the numerical Draize scoring code. The skin was also evaluated for ulceration and necrosis or any evidence of tissue
destruction. Additional signs were described. When there were no further positive scores noted in an animal scoring was discontinued in that animal.
An estimate of the LD50 was made based on the survival of animals during the study. - Preliminary study:
- No preliminary study conducted.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities. All animals survived the 2000 mg/kg dermal application.
- Clinical signs:
- other: Dermal Observations ( Table 1 in attached background material): Dermal reactions were absent to well defined on day 1, absent to slight on day 2, absent to well defined on day 3, absent to moderate on days 4 and 5, and absent to well defined on day 7. By
- Gross pathology:
- Necropsy findings (Table 3 in attached background material):
Necropsy results were normal in 7/10 animals. Kidney abnormalities were noted in two males and treated skin abnormalities in one female. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 is greater than 2000 mg/kg of body weight.
- Executive summary:
Objective:
To determine the potential for toxicity of the test article when applied dermally. This study was designed to comply with the standards set forth by EPA Acute Dermal Toxicity 40 CFR 798.1100 and EC Official Journal of the European Communities, L 383 A, Part B, Method B.3. Acute Dermal Toxicity, 12/29/92 and OECD Guidelines for Testing of Chemicals, No. 402, Acute Dermal Toxicity,
adopted 2/24/1987.
Method:
Five healthy male and five healthy female New Zealand White rabbits were dosed dermally with the test substance at 2000 mg/kg of body weight. The test article was kept in contact with the skin for 24 hours. Dermal responses were recorded at 30 - 60 minutes and at 24, 48 and 72 hours post patch removal and again on days 5, 7, 10 and 14. Animals were observed for toxicity and pharmacological effects at 1, 2 and 4 hours post dose and once daily for 14 days. All animals were observed twice a day for mortality. Body weights were recorded pretest, and on days 3, 7 and 14 or at death. All animals were examined for gross pathology.
Summary:
All animals survived the 2000 mg/kg dermal application.
There were no abnormal systemic signs noted during the observation period.
Dermal reactions were absent to well defined on day 1, absent to slight on day 2, absent to well defined on day 3, absent to moderate on days 4 and 5, and absent to well defined on day 7. By days 10 and 14, dermal reactions were absent to slight.
Body weight changes were normal in 8/10 animals. One male and one female lost weight at some time during the observation period.
Necropsy results were normal in 7/10 animals. Kidney abnormalities were noted in two males and treated skin abnormalities in one female.
Conclusion:
The LD50 is greater than 2000 mg/kg of body weight.
Reference
Please refer to attached background material for Tables 1 -3:
Table 1: Body weights, dose volume in grams and dermal observations
Table 2: Systemic observations
Table 3:Necropsy observations
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute Oral Toxicity:
5000 mg/kg:
Nine of ten animals survived the 5000 mg/kg oral dose. One male died on day 3 with predeath physical signs of diarrhea, chromodacryorrhea, soiling of the anogenital area, piloerection, lethargy, flaccid muscle tone, brown staining of the nose/mouth area and wetness of the anogenital area. Necropsy revealed abnormalities of the thymus, lungs, liver, kidneys, spleen and gastrointestinal tract, as well as soiling and wetness of the anogenital area. Physical signs noted in survivors included diarrhea, soiling of the anogenital area, lethargy, bloated abdomen, piloerection, wetness of body areas, brown staining of the nose/mouth area and localized alopecia. Body weight changes were normal in 7/9 survivors. Two males lost weight by day 3 but gained normally by day 7. Necropsy results of survivors were normal in 2/9 animals. Localized alopecia was noted in 7/9 animals.
2000 mg/kg:
Nine of ten animals survived the 2000 mg/kg oral dose. One male died on day 2 with predeath physical signs of lethargy, dyspnea and soiling of the anogenital area. A necropsy was not performed since the animal was cannibalized. Physical signs of diarrhea, soiling of the anogenital area, lethargy, brown staining of the nose/mouth area and wetness of the anogenital area were noted in survivors. Body weight changes were normal in 8/9 survivors. One female lost weight during the second week of the observation period. Necropsy results of survivors were normal.
Acute Dermal Toxicity:
All animals survived the 2000 mg/kg dermal application.
There were no abnormal systemic signs noted during the observation period.
Dermal reactions were absent to well defined on day 1, absent to slight on day 2, absent to well defined on day 3, absent to moderate on days 4 and 5, and absent to well defined on day 7. By days 10 and 14, dermal reactions were absent to slight.
Body weight changes were normal in 8/10 animals. One male and one female lost weight at some time during the observation period.
Necropsy results were normal in 7/10 animals. Kidney abnormalities were noted in two males and treated skin abnormalities in one female.
Acute Inhalation Toxicity:
Inhalation is not considered an appropriate route of exposure and a study has therefore not been conducted.
Justification for classification or non-classification
The substance does not meet the criteria for classification for the oral and dermal routes based on the LD50 results of >5000 mg/kg bw and >2000 mg/kg bw respectively.
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