Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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
Oral:
The acute oral toxicity of test item was investigated in a group of five male and five female CD rats at a dosage of 2000 mg/kg based on OECD 401. There was no death and no sign of reaction to treatment. All animals achieved expected bodyweight gains and necropsy revealed no significant macroscopic lesion. Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg.
Dermal:
The acute percutaneous toxicity of test item was investigated in a group of five male and five female CD rats according to EU method B3. There was no death. There was no local or systemic sign of reaction to treatment. The animals achieved anticipated bodyweight gains. Necropsy findings were unremarkable. Under the conditions of this study, the acute percutaneous median lethal dosage (LD50) of the test material was 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
- Study period:
- From 1991-07-26 to 1991-08-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study in accordance with recognised test guideline but: Lot/batch No.and Expiration date were not stated NOTE: study deemed acceptable because spectral data are available, covering approximately before and after the test period - see section 1.4 Analytical Information.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Substance type: Organic
- Physical state: fine off-white powder
- Analytical purity: Approximately 100%
- Storage condition of test material: at ambient temperature - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (U.K.) Limited, Margate, Kent, England.
- Age at study initiation: approximately 5 weeks old
- Weight at study initiation: 148-161g (male); 131-144g (female)
- Fasting period before study: 18 hours
- Housing: stainless steel grid cages measuring 54 x 33 x 20 cm (Steven Clarke Fabrications Limited, Alva, Clackmannanshire, Scotland). Five animals of the same sex were accommodated in each cage. The cages were suspended in mobile stainless steel racks.
- Diet (e.g. ad libitum): commercially-available complete pelleted rodent diet (Laboratory Animal Diet No.1, from Biosure, Manea, Cambridgeshire, England) was fed without restriction
- Water: free access to tap water supplied in a single bottle per cage and re-filled as required. The water was taken from the public supply; in England the supply and quality of this water is governed by Department of the Environment regulations.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (range 18°-25°C)
- Humidity (%): 55% R.H. (range 40%-70% R.H.)
- Air changes (per hr): 15 complete air changes per hour without recirculation
- Photoperiod (hrs dark / hrs light): lighting cycle of 12 hours of artificial light per day
IN-LIFE DATES: From: 26 July 1991 To: 9 August 1991 - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% w/v methylcellulose in purified water (obtained through the reverse osmosis of tap water).
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bodyweight, at a volume-dosage of 20 mL/kg
DOSAGE PREPARATION: The test material was prepared at the appropriate concentration in 0.5% w/v methylcellulose in purified water (obtained through the reverse osmosis of tap water). The dosage was calculated and expressed gravimetrically in terms of the material as received. A fresh formulation of the test material was prepared on the morning of administration and any surplus remaining after dosing was destroyed on the same day. - Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Three separate inspections were made during the first hour after dosing and two further inspections during the remainder of Day 1. From Day 2 onwards, the animals were inspected twice daily (morning and afternoon).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The type, time of onset and duration of reactions to treatment were recorded. The bodyweight of each animal was recorded on the day before dosing and on Days 1, 8 and 15. - Preliminary study:
- A preliminary study was carried out using one group of one male and one female rat given a single oral administration of test item at a dosage of 800 mg/kg bodyweight, at a volume-dosage of 20 ml/kg in 0.5% w/v aqueous methylcellulose. There was no death and no sign of reaction to treatment.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death
- Clinical signs:
- other: No signs of reaction to treatment
- Gross pathology:
- Necropsy revealed no significant macroscopic lesion
- Interpretation of results:
- other: low oral toxicity
- Conclusions:
- Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mk/kg. Accordingly, the test item was assigned to the class 'low oral toxicity'.
- Executive summary:
The acute oral toxicity of test item, was investigated in a group of five male and five female CD rats at a dosage of 2000 mg/kg based on OECD 401. The animals were starved overnight prior to dosing. The test material was administered at a volume-dosage of 20 ml/kg in 0.5% w/v aqueous methylcellulose. Mortality and signs of reaction to treatment were recorded during a subsequent 14-day observation period. The animals were killed on the following day and subjected to necropsy.
There was no death and no sign of reaction to treatment. All animals achieved expected bodyweight gains and necropsy revealed no significant macroscopic lesion. Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg. Accordingly, the test item was assigned to the class 'low oral toxicity'.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 2 (reliable with restrictions)
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:
- From 1996-01-17 to 1996-02-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study in accordance with recognised test guideline but: Lot/batch No.: not stated Expiration date of the lot/batch: not stated NOTE: study deemed acceptable because spectral data for A-3622 are available, covering before and after the test period - see section 1.4 Analytical Information.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 92/96/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- - Physical state: fine, cream, cohesive powder
- Storage condition: ambient temperature - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: The male animals were approximately seven to eight weeks old and the females were approximately ten to eleven weeks old.
- Weight at study initiation: in the range 196 - 209 g for males and 204 - 219 g for females.
- Fasting period before study: not applicable
- Housing: stainless steel grid cages (RS Biotech, Northants, England). The grid floors ensured rapid removal of waste material to undertrays which were cleaned as necessary. Five animals of the same sex were housed in each cage. The cages were suspended in mobile stainless steel racks.
- Diet (e.g. ad libitum): commercially-available complete pelleted rodent diet (RM I(E) SQC, from Special Diets Services Limited, Witham, Essex, England) was fed without restriction. The diet contained no added antibiotic or other chemotherapeutic or prophylactic treatment.
- Water (e.g. ad libitum): free access to tap water taken from the public supply
- Acclimation period: at least five days was allowed before administration of the test material.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (range 19- 25°C)
- Humidity (%): 55% RH (range 40%-70% R.H),
- Air changes (per hr): at least 10 complete air changes per hour without recirculation
- Photoperiod (hrs dark / hrs light): lighting cycle of 12 hours of artificial light per day.
IN-LIFE DATES: From: 25 January 2009 To: 8 February 2009 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 cm x 5 cm
- % coverage: approximately 10% of the body surface area
- Type of wrap if used: The test material was applied to the skin by a 5 cm x 5 cm gauze patch. and occluded with aluminium foil. The foil was kept in place and protected by a pad of cotton wool and a bandage of waterproof plaster and tape wrapped twice around the trunk of the body with sufficient tension to ensure the dose remained securely in place.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dermal site was gently wiped with wet disposable tissues to remove residual test material.
- Time after start of exposure: the dressings were removed 24 hours after administration
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the quantity of dose was determined for each animal according to its bodyweight on the morning of dosing, however volumes or weights are not stated in the report. - Duration of exposure:
- 24 hours
- Doses:
- maximum practicable dosage of 2000 mg/kg (Regulatory Limit test).
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: three separate recordings of signs were made during the first hour after administration and two further recordings during the remainder of Day 1. From Day 2 onwards, the animals were inspected twice daily and recordings of systemic and local signs were made once daily. The type, time of onset and duration of reactions to treatment were recorded.
- Necropsy of survivors performed: yes. All body cavities were opened, larger organs were sectioned and the gastrointestinal tract was opened at intervals for examination of the mucosal surfaces. All abnormalities were described or the normal appearance of major organs was confirmed. Each dermal application site was examined in situ, and in macroscopic section to obtain more information on dermal effects of treatment.
- Other examinations performed: The bodyweight of each animal was recorded on the day before dosing and on Days 1, 8 and 15. Macroscopically abnormal tissues were preserved in 4% neutral buffered fonnaldehyde and retained against future possible histopathological requirements. - Statistics:
- not applicable
- Preliminary study:
- A preliminary study was carried out using one female rat given A-3622 at a dosage of 2000 mg/kg bodyweight. There was no sign of reaction to treatment.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no death
- Clinical signs:
- other: There was no systemic sign of reaction to treatment. There was no local sign of reaction to treatment at the application site.
- Gross pathology:
- Necropsy findings were confined to large submandibular lymph nodes in one male animal.
See attached background information for table of necroscopy observations. - Other findings:
- - Local signs: There was no local sign of reaction to treatment at the application site.
see attached background information for table of necroscopy observations. - Interpretation of results:
- other: low percutaneous toxicity
- Conclusions:
- Under the conditions of this study, the acute percutaneous median lethal dosage (LD50) of the test material was greater than 2000 mg/kg. Accordingly, the test item was assigned to the class 'low percutaneous toxicity'.
- Executive summary:
The acute percutaneous toxicity of test item was investigated in a group of five male and five female CD rats according to EU method B3. The test material was applied to the closely-clipped dorsum of each animal at a dosage of 2000 mg/kg bodyweight, and was covered by an occlusive dressing for 24 hours. Mortality, systemic and local signs of reaction to treatment were recorded during a subsequent 14 -day period of observation. The animals were killed on the following day and subjected to necropsy. There was no death. There was no local or systemic sign of reaction to treatment. The animals achieved anticipated bodyweight gains. Necropsy findings were unremarkable. Under the conditions of this study, the acute percutaneous median lethal dosage (LD50) of the test material was greater than 2000 mg/kg. Accordingly, the test item was assigned to the class 'low percutaneous toxicity'.
Reference
Mortality
Dosage |
Mortality |
||
Male |
Female |
Combined |
|
2000
|
0/0 |
0/0 |
0/0 |
Systemic signs
Signs |
Number of animals showing signs+ |
|
Males |
Females |
|
No abnormality detected |
5 |
5 |
Total number of survivors |
5 |
5 |
+ Five animals in each sex group
Local signs
Signs |
Number of animals showing signs+ |
|
Males |
Females |
|
No abnormality detected |
5 |
5 |
Total number of survivors |
5 |
5 |
+ Five animals in each sex group
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 2 (reliable with restrictions)
Additional information
Justification for classification or non-classification
Oral LD50: >2000 mg/kg body weight
Dermal LD50: >2000 mg/kg body weight
Therefore in accordance with Regulation (EC) No. 1272/2008 (amended by 286/2011) Table 3.1.1 , this substance should not be classified for acute toxicity.
Specific target organ toxicity-single exposure:
Oral:
Death: No death at 2000 mg/kg (0/10).
Clinical observations: No signs of reaction to treatment
Body weight: All animals achieved expected bodyweight gains
Macroscopic Findings: Necropsy revealed no significant macroscopic lesion
Dermal:
Death: No death at 2000 mg/kg (0/10).
Clinical observations: No systemic sign of reaction to treatment
Body weight: The animals achieved anticipated bodyweight gains.
Macroscopic Findings: Necropsy findings were confined to large submandibular lymph nodes in one male animal.
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.8.1 and 3.8.2, this substance should not be classified for this endpoint.
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.