Registration Dossier
Registration Dossier
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EC number: 201-803-0 | CAS number: 88-14-2
Endpoint summary
Administrative data
Description of key information
Acute Oral Toxicity:
On the basis of structurally and functionally similar read across substances, the test chemical cannot be classified as the CLP criteria for acute oral toxicity study.
Acute Inhalation toxicity:
Test chemical has very low vapour pressure (13.732204 Pa.= 0.103 mmHg),So the potential for the generation of inhalable vapours is very low.Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely.Therefore the acute inhalation toxicity end point was considered for waiver.
Acute dermal toxicty:
On the basis of structurally and functionally similar read across substances, the test chemical cannot be classified as the CLP criteria for acute dermal toxicity study.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer- reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute Oral toxicity test was carried out to study the effects of test chemical on deer mice (Peromyscus maniculatus).
- GLP compliance:
- no
- Test type:
- other: No data available
- Limit test:
- no
- Species:
- other: Deer mice
- Strain:
- other: Peromyscus maniculatus
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: 20 gm
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- 1225 mg/kg/day
- No. of animals per sex per dose:
- 2 to 4 animals were used per geometrically spaced dosage level
And
6 to 20 animals per experiment - Control animals:
- not specified
- Details on study design:
- Details on study design
- Duration of observation period following administration: 3 days
- Frequency of observations and weighing:no data available
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No data available - Statistics:
- Thompson (1948) and Thompson and Weil (1952)
- Preliminary study:
- No data available
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 1 225 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed in treated deer mice at dose level 1225 mg/kg/day
- Mortality:
- No mortality was observed in treated deer mice at dose level 1225 mg/kg/day
- Clinical signs:
- other: No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
- Interpretation of results:
- other: Not classified
- Conclusions:
- The lethal concentration (LD50) value for acute oral toxicity test was considered to be >1225 mg/kg/day when deer mice were treated with test chemical orally via gavage over the 3-day test period without killing more than 50% of the test animals.
- Executive summary:
Acute oral toxicity study was done in 2 to 4 deer mice using test chemical .No Mortality was observed at dose 1225 mg/kg/day.Hence,LD50 value was considered to be >1225 mg/kg/day when deer mice were treated with test chemical orally via gavage over the 3-day test period without killing more than 50% of the test animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 225 mg/kg bw
- Quality of whole database:
- Data is Klimicsh 2 and from publication
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Clinical signs:
- other: other:
Reference
Endpoint conclusion
- Quality of whole database:
- Waiver
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Experimental data from various test chemicals
- Justification for type of information:
- Data for the target chemical is summarized based on the various test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE for the target CAS is summarized based on data from various test chemicals.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Species:
- other: 1. 2.
- Strain:
- other: 1. Not specified 2. Not specified
- Sex:
- not specified
- Type of coverage:
- other: Dermal
- Vehicle:
- other: 1. Not specified 2. Not specified
- Details on dermal exposure:
- 1. Not specified
2. Not specified - Duration of exposure:
- 1. Not specified
2. Not specified - Doses:
- 1. 2000 mg/kg bw
2. 5000 mg/kg bw - No. of animals per sex per dose:
- 1. Not specified
2. Not specified - Control animals:
- other: not specified
- Details on study design:
- 1. Not specified
2. Not specified - Statistics:
- 1. Not specified
2. Not specified - Preliminary study:
- 1. Not specified
2. Not specified - Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality observed
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- 1. 50% mortality observed
2. No mortality observed - Clinical signs:
- other: 1. Not specified 2. Not specified
- Gross pathology:
- 1. Not specified
2. Not specified - Other findings:
- 1. Not specified
2. Not specified - Interpretation of results:
- other: Not classified
- Conclusions:
- Based on the above data from structurally and functionally similar read across substances, it can be concluded that LD50 value was >2000 mg/kg bw. Thus, comparing this value with the criteria of CLPregulation,test chemical can be “Not classified” for acute dermal toxicity.
- Executive summary:
In different studies, test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rabbits. On the basis of structurally and functionally similar read across substances, the test chemical was supported as follows:
The acute dermal toxicity study was conducted on rabbits for 14 days period. 50% mortality was observed at a dose level of 2000 mg/kg. Thus, based on the LD50 value, the test chemical cannot be classified as per the CLP regulation.
The acute dermal toxicity study was conducted on rabbits for 14 days period. No mortality was observed at a dose level of 5000 mg/kg. Thus, based on the LD50 value >5000 mg/kg bw, the test chemical cannot be classified as per the CLP regulation.
Thus, based on the above data from structurally and functionally similar read across substances, it can be concluded that LD50 value was >2000 mg/kg bw. Thus, comparing this value with the criteria of CLPregulation,test chemical can be “Not classified” for acute dermal toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Data is Klimicsh 2 and from publication
Additional information
Acute Oral Toxicity:
In different studies, test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats.The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.
Acute oral toxicity study was done in 2 to 4 deer mice using test chemical .No Mortality was observed at dose 1225 mg/kg/day.Hence,LD50 value was considered to be >1225 mg/kg/day when deer mice were treated with test chemical orally via gavage over the 3-day test period without killing more than 50% of the test animals.
Acute oral toxicity study was done in rats using test chemical. A dose range of 1700 mg/kg to 2900 mg/kg was used. No mortality was observed.Hence, the LD50 value was observed to be 2200 mg/kg when rats were treated with test chemical orally.
The acute oral toxicity study was conducted on rats for 14 days period. 50% mortality was observed at a dose level of 2500 mg/kg. Thus, based on the LD50 value, the test chemical cannot be classified as per the CLP regulation.
Thus, based on the above studies and predictions on test chemical, it can be concluded that LD50 value was >2000 mg/kg bw. Thus, comparing this value with the criteria of CLPregulation,test chemical can be “Not classified” for acute oral toxicity.
Acute Inhalation Toxicity:
Test chemical has very low vapour pressure (13.732204 Pa.= 0.103 mmHg),So the potential for the generation of inhalable vapours is very low.Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely.Therefore the acute inhalation toxicity end point was considered for waiver.
Acute dermal toxicity:
In different studies, test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rabbits. On the basis of structurally and functionally similar read across substances, the test chemical was supported as follows:
The acute dermal toxicity study was conducted on rabbits for 14 days period. 50% mortality was observed at a dose level of 2000 mg/kg. Thus, based on the LD50 value, the test chemical cannot be classified as per the CLP regulation.
The acute dermal toxicity study was conducted on rabbits for 14 days period. No mortality was observed at a dose level of 5000 mg/kg. Thus, based on the LD50 value >5000 mg/kg bw, the test chemical cannot be classified as per the CLP regulation.
Thus, based on the above data from structurally and functionally similar read across substances, it can be concluded that LD50 value was >2000 mg/kg bw. Thus, comparing this value with the criteria of CLPregulation,test chemical can be “Not classified” for acute dermal toxicity.
Justification for classification or non-classification
Thus, comparing this value with the criteria of CLP regulation,test chemical can be “Not classified” for acute oral toxicity, acute dermal and acute inhalation toxicity.
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