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EC number: 939-512-2 | CAS number: 85681-55-6
- 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
The acute oral LD50 is between 600 and 1650 mg/kg bw. The acute dermal LD50 is > 2000 mg/kg bw. No data are available for acute inhalation toxicity.
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:
- weight of evidence
- Study period:
- 1997-09-12 to 1997-09-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley, Indianapolis, Indiana
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 202 - 220 g
- Fasting period before study: Yes, overnight
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
Temperature, humidity and light controlled room (DHEW publication No. 86-23 (NIH))
IN-LIFE DATES: From: 1997-09-12 To: 1997-09-26 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 33%
- Dosage volume: 1.01 - 1.10 g
Metal dosing cannula - Doses:
- 5 g/kg bw (1650 mg active/kg bw)
- No. of animals per sex per dose:
- five males/five females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations - frequently on day of dosing (1, 2.5 and 4 hours) and once daily thereafter; bodyweights on study initiation, at 7 and 14 days post-administration and at death.
- Necropsy of survivors performed: yes - Statistics:
- Calculations of the LC50 and 95% confidence limits: Method of moving averages, Weil CC (1952) table for convenient calculations of median effective dose (LD50 and ED50) and instruction in their use. Biometrics, 8.
- Preliminary study:
- Not performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- < 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- < 1 650 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 8/10 rats died by Day 1 of the post-administration period. The remaining two rats (2 x male) dosed with the test material survived until Day 14 of the post-administration period.
- Clinical signs:
- other: salivation and hypoactivity were observed by the 2.5 and 4 hour observation periods for the three males that died. There were no clinical signs of toxicty observed in any of the females.
- Gross pathology:
- Occurred only in animals that died during the course of the study:
External observations: bloody muzzle and wet tail
Internal observations: confined to the gastrointestinal tract, stomach and small intestine distended with gas and fluid, small intestine appeared red with haemorrhagic sites. - Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral administration of a 33% solution of the test material (5 g/kg bw) resulted in an LD50 <1650 mg active/kg bw.
- Executive summary:
The acute oral toxicity of the test material as a 33% solution in water was assessed in male and female rats in accordance to OECD Guideline No. 401. Five male and five female rats were dosed by oral gavage with 5000 mg/kg bw (1650 mg active/kg) . After a 14 day observation period there were 8/10 mortalities. There were no treatment related effects observed on bodyweight or at gross necropsy of the remaining two male rats. The LD50 was < 1650 mg active/kg bw.
In accordance with Regulation (EC) No. 1272/2008 the substance is classified for acute toxicity by the oral route. In the absence of a derived LD50 value the substance is labelled as Category 4.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1997-09-30 to 1997-10-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley, Indianapolis, Indiana
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 202 - 223 g
- Fasting period before study: Yes, overnight
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
Temperature, humidity and light controlled room (DHEW publication No. 86-23 (NIH))
IN-LIFE DATES: From: 1997-09-30 To: 1997-10-14 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 33%
- Dosage volume: 0.40-0.45 g
Metal dosing cannula - Doses:
- 2 g/kg bw (660 mg active/kg bw)
- No. of animals per sex per dose:
- five males/five females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations - frequently on day of dosing (1, 2.5 and 4 hours) and once daily thereafter; bodyweights on study initiation, at 7 and 14 days post-administration and at death.
- Necropsy of survivors performed: yes - Statistics:
- Calculations of the LC50 and 95% confidence limits: Method of moving averages, Weil CC (1952) table for convenient calculations of median effective dose (LD50 and ED50) and instruction in their use. Biometrics, 8.
- Preliminary study:
- Not performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 660 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 2/10 rats (1 male/1 female) died by Day 2 of the post-administration period. The remaining rats dosed with the test material survived until Day 14 of the post-administration period.
- Clinical signs:
- other: Loose stools were observed for 4 males and in addition two males appeared hyoactive by the Day 1 observation. One of the males showing both clinical signs of toxicity died on Day 2. The other animals showed no indications of toxicity throughout the rest o
- Gross pathology:
- Occurred only in animals that died during the course of the study:
Internal observations: confined to the gastrointestinal tract, stomach and small intestine distended with gas and fluid, small intestine appeared red in colour. - Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral administration of a 33% solution of the test material (2 g/kg bw) resulted in an LD50 > 660 mg active/kg bw.
- Executive summary:
The acute oral toxicity of the test material as a 33% solution in water was assessed in male and female rats in accordance to OECD Guideline No. 401. Five male and five female rats were dosed by oral gavage with 2000 mg/kg bw (660 mg active/kg) . After a 14 day observation period there were 2/10 mortalities. Clinical effects were observed in three other male rats at the Day 1 observation period. No treatment related effects were noted on bodyweight gain or at gross necropsy of the surviving rats at the end of the observation period. The LD50 was > 660 mg active/kg bw.
In accordance with Regulation (EC) No. 1272/2008 the substance is classified for acute toxicity by the oral route. In the absence of a derived LD50 value the substance is labelled as Category 4.
Referenceopen allclose all
Table 1: Body weight gain
Rat Number |
Sex |
7 day Bwt (g) |
14 day Bwt (g) |
587 |
M |
283 |
322 |
588 |
M |
276 |
310 |
589 |
M |
267 |
303 |
590 |
M |
258 |
287 |
591 |
M |
- |
- |
592 |
F |
216 |
220 |
593 |
F |
229 |
237 |
594 |
F |
250 |
253 |
595 |
F |
- |
- |
596 |
F |
218 |
221 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 650 mg/kg bw
- Quality of whole database:
- Two guideline GLP studies are available (Klimisch score 1).
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:
- 1997-09-10 to 1997-09-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- 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: Kuiper Rabitry, Gary, Indiana
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 2.01 - 2.38 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
Temperature, humidity and light controlled room (DHEW publication No. 86-23 (NIH))
IN-LIFE DATES: From: 1997-09-10 To: 1997-10-24 - Type of coverage:
- occlusive
- Vehicle:
- other: moistened with water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 30% total body area shaved
- % coverage: 10% total body surface
- Type of wrap if used: Plastic sheeting secured with non-irritating Kendall Curity Satndard Porus tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg
- Concentration (if solution): Not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: no - Duration of exposure:
- 24 hours
- Doses:
- 2 g/kg
- No. of animals per sex per dose:
- 5 male/5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently on day of dosing (1, 2.5 and 4 hours) and once daily thereafter; bodyweights on study initiation, at 7 and 14 days post-administration and at death.
- Necropsy of survivors performed: yes - Statistics:
- Calculations of the LC50 and 95% confidence limits: Method of moving averages, Weil CC (1952) table for convenient calculations of median effective dose (LD50 and ED50) and instruction in their use. Biometrics, 8.
- Preliminary study:
- Not performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 4/10 rabbits (3 male/1 female) died by Day 5 of the post-administration period. The remaining rabbits dosed with the test material survived until Day 14 of the post-administration period.
- Clinical signs:
- other: Pharmacotoxic observations were limited to the skin at the application sites and included oedema, erythema, chemical burns, scar tissue, coriaceousness and eschar. Effects were reversible by the 14 day observation period in only two animals (1 male/1 fema
- Gross pathology:
- External observations: severe tissue damage and necrosis
Internal observations: stomach devoid of contents. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal administration of the test material (2 g/kg bw) resulted in an LD50 > 2000 mg/kg bw.
- Executive summary:
In this study, performed in accordance with OECD TG 402 under GLP, the substance, moistened with water, was applied to the shaved skin of rabbits (five/sex) at a dose of 2000 mg/kg bw under occlusive conditions for 24 hours. Four animals died during the 14-day observation period. No treatment related effects were noted on bodyweight gain in the remaining animals. Observations noted during the study were limited to the skin at the application sites and included erythema, edema, chemical burns, scar tissue, coriaceousness and eschar. At necropsy external observations included severe tissue damage and necrosis of skin at the application site of all four animals that died prematurely and scar tissue/scar tissue and eschar in four of the surviving animals. Two animals showed no external changes. Internally, two of the animals that died prematurely had empty stomachs. The remaining animals showed no gross internal changes. The LD50 was > 2000 mg/kg bw.
In accordance with Regulation (EC) No. 1272/2008 the substance is not classified for acute toxicity by the dermal route.
Reference
Table 1: Body weight gain
Rabbit Number |
Sex |
Initial Bwt (kg) |
7 day Bwt (kg) |
14 day Bwt (kg) |
258 |
F |
2.02 |
1.97 |
2.13 |
259 |
F |
2.04 |
- |
- |
260 |
F |
2.30 |
2.35 |
2.43 |
261 |
F |
2.22 |
2.24 |
2.52 |
262 |
F |
2.14 |
1.94 |
2.05 |
274 |
M |
2.19 |
2.32 |
2.59 |
275 |
M |
2.02 |
- |
- |
276 |
M |
2.01 |
1.89 |
2.06 |
277 |
M |
2.38 |
- |
- |
278 |
M |
2.20 |
- |
- |
Table 2: clinical observations
Rabbit Number |
Sex |
Observation period |
||||||||||||||||
|
|
1h |
2.5h |
4h |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
Day 7 |
Day 8 |
Day 9 |
Day 10 |
Day 11 |
Day 12 |
Day 13 |
Day 14 |
258 |
F |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
OQ |
OQ |
OQ |
Q |
Q |
Q |
259 |
F |
√ |
√ |
√ |
LM |
LMO |
LMO |
X |
|
|
|
|
|
|
|
|
|
|
260 |
F |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
O |
OQ |
OQ |
Q |
Q |
261 |
F |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
MO |
O |
O |
O |
√ |
√ |
262 |
F |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
MO |
O |
O |
OQ |
OQ |
274 |
M |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
MO |
O |
O |
O |
√ |
√ |
275 |
M |
√ |
√ |
√ |
LMP |
LMOP |
LMOP |
X |
|
|
|
|
|
|
|
|
|
|
276 |
M |
√ |
√ |
√ |
LM |
LMO |
LMO |
LMO |
LMO |
LMO |
LMO |
MO |
MO |
MO |
MO |
O |
OQ |
OQ |
277 |
M |
√ |
√ |
√ |
LMP |
LMOP |
LMOP |
X |
|
|
|
|
|
|
|
|
|
|
278 |
M |
√ |
√ |
√ |
LMP |
LMOP |
LMOP |
LMOP |
X |
|
|
|
|
|
|
|
|
|
√ - Normal
X - Dead
L - Erythema
M - Oedema
O – Eschar and coriaceousness
P – Chemical burns
Q – Scar tissue
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- One guideline GLP study is available (Klimisch score 1).
Additional information
Acute oral toxicity
Two reliable studies are available. In the first study performed to OECD TG 401 under GLP, rats (five/sex) were dosed by gavage with 5000 mg/kg bw of a 33 %w/w solution of the substance (equivalent to 1650 mg substance/kg bw). Eight animals died during the 14-day observation period. No treatment-related effects were noted on bodyweight gain or at gross necropsy of the surviving rats at the end of the observation period. The LD50 was < 1650 mg substance/kg bw [Kukulinski M (1997a)]. In the second study performed to OECD TG 401 under GLP, rats (five/sex) were dosed by gavage with 2000 mg/kg bw of a 33 %w/w solution of the substance (equivalent to 660 mg substance/kg bw). Two animals died during the 14-day observation period. Clinical effects were observed in three other male rats at the Day 1 observation period. No treatment-related effects were noted on bodyweight gain or at gross necropsy of the surviving rats at the end of the observation period. The LD50 was > 660 mg substance/kg bw [Kukulinski M (1997b)].
Based on these two studies, the oral LD50 (rat) of the substance is between 660-1650 mg/kg bw/day.
Acute inhalation toxicity
No study is available.
Acute dermal toxicity
One reliable study is available. In this study, performed in accordance with OECD TG 402 under GLP, the substance, moistened with water, was applied to the shaved skin of rabbits (five/sex) at a dose of 2000 mg/kg bw under occlusive conditions for 24 hours [Kukulinski M (1997c)]. Four animals died during the 14-day observation period. No treatment related effects were noted on bodyweight gain in the remaining animals. Observations noted during the study were limited to the skin at the application sites and included erythema, oedema, chemical burns, scar tissue, coriaceousness and eschar. At necropsy external observations included severe tissue damage and necrosis of skin at the application site of all four animals that died prematurely and scar tissue/scar tissue and eschar in four of the surviving animals. Two animals showed no external changes. Internally, two of the animals that died prematurely had empty stomachs. The remaining animals showed no gross internal changes. Base on the results of this study the dermal LD50 (rabbit) is > 2000 mg/kg bw.
Justification for classification or non-classification
The acute oral LD50 is between 660 and 1650 mg/kg bw, based on the results of GLP studies performed to OECD 401. The substance is therefore classified as Acute Category 4 in accordance with the criteria in Regulation (EC) No 1272/2008.
The acute dermal LD50 is > 2000 mg/kg bw, based on the results of a GLP study performed to OECD TG 401. The substance is not classified in accordance with the criteria in Regulation (EC) No 1272/2008.
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.