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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 921-042-4 | CAS number: 24085-06-1
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: rat (wistar) m/f (OECD guideline 420, GLP) Discriminating dose 500mg/kg bw; 3 deaths (1/5m/2/5f) at 2000mg/kg bw.
Acute Dermal Toxicity: rat (wistar) m/f (OECD guideline 402, GLP) Limit test 2000 mg/kg bw- no deaths, limited dermal irritation
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:
- 31 August - 4 October, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Remarks:
- Organisation for Economic Co-operation and Development, Principles on Good Laboratory Practice (revised 1997, ENV/MCJCHEM (98) 17)
- Test type:
- fixed dose procedure
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (U K) Ltd, Margate, Kent, U K
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 228g to 246 g- males; 176 to 206 g-females
- Fasting period before study: overnight
- Housing: 5 to 6 per gender in solid-floor polypropylene cages furnished with woodflakes
- Diet (ad libitum): Rat and Mouse SQC Expanded Diet No.1, Special Diets Services Limi ted, Witha m, Essex, U K
- Water (ad libitum): mains drinking water
- Acclimation period: 5 days before
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19° to 25° C
- Humidity (%): 30-70 %
- Air changes (per hr): 15 approx
- Photoperiod (hrs dark / hrs light): 12 hours l ight (light cycle 06.00 to 18.00) and 12 hours darkness. - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Doses:
- 2,000 mg/kg and 500 mg/kg bodyweight
- No. of animals per sex per dose:
- 2 (preliminary study)
5 (Limit study) - Control animals:
- no
- Details on study design:
- For the purpose of the study the test material was freshly prepared, as required, as a suspension in arachis oil BP (Batch number T27, Analytical Supplies Ltd., Little Eaton, Derby, UK). The preparations were mixed thoroughly using a Silverson Homogeniser and vortex mixer.
The absorption of AH18579 was not determined.
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
At the end of the study the surviving animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormal ities was recorded . No tissues were retained .
Data evaluations included the relationship, if any, between the animals exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects. - Statistics:
- Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.
- Preliminary study:
- There were no deaths at dose levels of 500 and 2000 mg/kg bodyweight. Clinical observations noted at a dose level of 2000 mg/kg were hunched posture and pilo-erection.
Based on this information, dose levels of 2000 and 500 mg/kg bodyweight
were selected for the main study. - Sex:
- male
- Dose descriptor:
- discriminating dose
- Effect level:
- ca. 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- ca. 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2,000 mg/kg: Three animals (one male and two females) were found dead 1, 2 or 5 days after dosing.
500 mg/kg: No deaths - Clinical signs:
- other: 2,000 mg/kg: No signs of toxicity were noted during the day of dosing. Hunched posture was noted in four animals one day after dosing with pilo erection noted in three animals. Hunched posture was noted in seven animals on Day 2 and persisted in three an
- Gross pathology:
- 2,000 mg/kg:
Abnormalities noted at necropsy of animals that died du ring the study were haemorrhagic or abnormal ly red lungs, dark liver or patchy pallor of the liver, dark kidneys, haemorrhagic gastric mucosa, haemorrhage or sloughing of the non-glandular epithelium of the stomach and haemorrhagic small and large intestines. Abnormalities noted at necropsy of two animals that were killed at the end of the study were thickened non-glandula r epithelium of the stomach and/or stomach adhered to the liver. No abnormalities were noted at necropsy of all other animals that were killed at the end of the study.
500 mg/kg:
No abnormalities were noted at necropsy - Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the Wistar strain rat is considered to be between 500 and 2000 mg/kg.
- Executive summary:
The discriminating dose in the main study was established at 500 mg/kg, with three animals dosed with 2000 mg/kg (1 male, 2 female) found dead 1,2 and 5 days after dosing. Application of the current classification critieria set out in OECD 420 (Fixed dose procedure) results in a CLP classification for Acute Oral toxicity of Category 4, with an ATE of 500 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 500 mg/kg bw
- Quality of whole database:
- The study was conducted in 1999, in accordance with the OECD test method in force at that time, the study has recently been re-evaluated in accordance with modern classification criteria. The study is deemed to be a Klimisch 1 study
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:
- 21 January 2015 to 12 February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Based on OECD test guideline and GLP compliant
- 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
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Five male and five female Wistar (RccHanTM:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatization period of at least 5 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. At the start of the study the animals weighed at least 200 g, and were 8 to 12 weeks of age. The weight variation did not exceed ±20% of the mean weight for each sex.
The animals were housed in suspended solid floor polypropylene cages furnished with woodflakes. The initial two animals were housed individually throughout the study. The further group of eight animals (four male and four female) were housed individually during the 24-Hour exposure period and in groups of four, by sex, for the remainder of the study. Free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- The appropriate amount of test item, moistened with arachis oil BP, was applied as evenly as possible to an area of shorn skin (approximately 10% of the total body surface area). A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. The animals were caged individually throughout the study. Shortly after dosing the dressings were examined to ensure that they were securely in place.
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 BP to remove any residual test item.
As no mortalities were noted a further group of animals (four males and four females) was similarly treated with the test item at a dose level of 2000 mg/kg body weight to give a total of five males and five females. The animals were caged individually for the 24-Hour exposure period. After the 24-Hour contact period the bandages were carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test item. These animals were returned to group housing for the remainder of the test period. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded prior to application of the test item on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: At the end of the study the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
- Other examinations performed: Clinical signs and body weight development were monitored during the study. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Dermal Irritation. Signs of dermal irritation noted were very slight to well-defined erythema, very slight edema, crust formation, light brown discoloration of the epidermis, small superficial scattered scabs and scab lifting to reveal glossy skin.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
The test item does not meet the criteria for classification according to CLP (1272/2008/EC). - Executive summary:
Introduction
The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat.
Methods
Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg body weight. Based on the results of the initial test, a further group of eight animals (four males and four females) was similarly treated. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. There were no deaths.
Clinical Observations. There were no signs of systemic toxicity.
Dermal Irritation. Signs of dermal irritation noted were very slight to well-defined erythema, very slight edema, crust formation, light brown discoloration of the epidermis, small superficial scattered scabs and scab lifting to reveal glossy skin.
Body Weight. All animals showed expected gains in body weight.
Necropsy. No abnormalities were noted at necropsy.
Conclusion
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
The test item does not meet the criteria for classification according to CLP (1272/2008/EC).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 500 mg/kg bw
- Quality of whole database:
- The study is contemporary, conducted in accordance with OECD and GLP guidelines and is deemed to be a Klimisch 1 study
Additional information
The available acute oral toxicity study was performed in 1999 in accordance with OECD Guideline 420 and GLP. The discriminating dose in the main study was established at 500 mg/kg, with three animals dosed with 2000 mg/kg (1 male, 2 female) found dead 1,2 and 5 days after dosing. Based upon the classification criteria in force at that time (Directive 67/548/EEC as adapted by Directive 93/21/EEC), the existing conclusion of the study director is that the LD50, based upon the fixed dose procedure is >2000mg/kg with a discriminating dose of 500mg/kg. Application of the current classification criteria in accordance with 1272/2008/EC results in a classification of Acute Toxicity 4 based upon the deaths observed in the female animals at 2000 mg/kg.
Acute dermal toxicity was assessed using OECD guideline 402 in accordance with GLP. A limit test at 2000 mg/kg bw was conducted which did not result in mortality or signs of systemic toxicity in the treated animals. Signs of dermal irritation noted in several animals included very slight to well-defined erythema, very slight edema, crust formation, light brown discoloration of the epidermis, small superficial scattered scabs and scab lifting to reveal glossy skin. The dermal reactions informed the need to assess the dermal irritancy potential in the integrated testing strategy.
Justification for selection of acute toxicity – oral endpoint
A single acute oral toxicity study is available, conducted in accordance with GLP and the OECD guideline in force at the time of testing.
Justification for selection of acute toxicity – dermal endpoint
A single acute dermal toxicity study is available, conducted in accordance with GLP and the OECD guideline currently in force.
Justification for classification or non-classification
The discriminating dose in the acute oral toxicity study was established at 500 mg/kg, with three animals dosed with 2000 mg/kg (1 male, 2 female) found dead 1,2 and 5 days after dosing. Application of the current classification criteria set out in OECD 420 (Fixed dose procedure) results in a CLP classification for Acute Oral toxicity of Category 4, with an ATE of 500 mg/kg.
Given the lack of systemic toxicity observed in the acute dermal toxicity study, no classification for that endpoint is justified.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)