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Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats, mice and guinea pigs for the test chemical. The LD50 value is 2200 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity:

The acute inhalation toxicity dose (LC50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LC50 value is 8949 mg/m3. The study concluded that LC50 value is >5 mg/L, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity.

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is 5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Qualifier:
no guideline available
Principles of method if other than guideline:
The toxicity and toxic manifestations of phenetole(as influenced bt chemical changes in DDT) in mice.
GLP compliance:
not specified
Test type:
standard acute method
Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Not available
- Age at study initiation:Not available
- Weight at study initiation:20-30 gm
- Fasting period before study:Not available
- Housing:individual cages
- Diet (e.g. ad libitum):Purina dog chow(ad libitum)
- Water (e.g. ad libitum):water(ad libitum)
- Acclimation period:Not available

ENVIRONMENTAL CONDITIONS
- Temperature (°C):Not available
- Humidity (%):Not available
- Air changes (per hr):Not available
- Photoperiod (hrs dark / hrs light):Not available

IN-LIFE DATES: From: To:
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle:5,10 or 25 percent solutions in olive oil
- Amount of vehicle (if gavage):Not available
- Justification for choice of vehicle:Not available
- Lot/batch no. (if required):Not available
- Purity:Not available

MAXIMUM DOSE VOLUME APPLIED:Not applicable

DOSAGE PREPARATION (if unusual):5,10 or 25 percent solutions in olive oil

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:Not available
Doses:
1200,1400,1600,1800,2000 & 2200 mg/kg
No. of animals per sex per dose:
1200mg/kg-10
1400mg/kg-10
1600mg/kg-10
1800mg/kg-10
2000mg/kg-10
2200mg/kg-10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing:no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs-incidence of tremors,convulsions & fatalities noted
Statistics:
Not availble
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50 percent mortality observed
Mortality:
50 percent mortality observed at 2200 mg/kg,whereas 80 percent mortality was seen at dose 2000 mg/kg and 10 percent mortality was seen at 1600 & 1800 mg/kg respectively.
Clinical signs:
Shortly after the administration the animals became depressed and with larger doses they passed into deep necrosis in 2-3 hrs and majority of animals died in a comatose condtion within 1-2 days.
Body weight:
Not available
Gross pathology:
Not available
Other findings:
Not available
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of phenetole in mouse was found to be 2200 mg/kg of body weight as 50 percent mortality was observed at this dose.
Executive summary:

In the study the acute oral toxicity of test compound was determined in white mice by orally administering the test compound in olive oil at doses 1200, 1400,1600,1800,2000 & 2200 mg/kg and observed for clinical signs and mortality for 1 week. The acute oral median lethal dose (LD50) of test chemical in mouse was found to be 2200 mg/kg of body weight (50 percent mortality observed), 80 percent mortality was seen at dose 2000 mg/kg and 10 percent mortality was seen at 1600 & 1800 mg/kg respectively. Thus considering the CLP criteria for classification it can be assessed that the given test chemical is non toxic via oral route as it exceeds the criteria of 2000 mg/kg bw for the substance to be classified as toxic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 200 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from publication.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
standard acute method
GLP compliance:
not specified
Test type:
standard acute method
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Duration of exposure:
2 h
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LC50
Effect level:
8 949 mg/m³ air
Based on:
test mat.
Exp. duration:
2 h
Remarks on result:
other: other details not available
Mortality:
Lethal concentration, 50 percent kill
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The 2hr.acute inhalation median lethal concentration (LC50) of anisole in rat was found to be 8949 mg/m3. Acute inhalation toxicity of anisole to rat by inhalative route indicates that the substance does not exhibits acute toxicity by the inhalative route.
Executive summary:

The 2hr.acute inhalation median lethal concentration (LC50) of anisole in rat was found to be 8949 mg/m3. Acute inhalation toxicity of anisole to rat by inhalative route indicates that the substance does not exhibits acute toxicity by the inhalative route.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
8 949 mg/m³
Quality of whole database:
Data is from secondary source.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Qualifier:
no guideline available
Principles of method if other than guideline:
Not available
GLP compliance:
not specified
Test type:
other: No data
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not available
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
Details not available
Duration of exposure:
Details not available
Doses:
Details not available
No. of animals per sex per dose:
Details not available
Control animals:
not specified
Details on study design:
Details not available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Non toxic
Mortality:
Details not available
Clinical signs:
Details not available
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A dermal LD50 study was conducted in which 5000 mg/kg of Anisole was applied to the skin of rabbits. The animals were observed for mortality and/or systemic effects for 14 days. No further details were provided. Acute dermal LD50/rabbits > 5000 mg/kg bw was determined.
Executive summary:

A dermal LD50 study was conducted in which 5000 mg/kg of Anisole was applied to the skin of rabbits. The animals were observed for mortality and/or systemic effects for 14 days. No further details were provided. Acute dermal LD50/rabbits > 5000 mg/kg bw was determined.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from publication.

Additional information

Acute oral toxicity:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats, mice and guinea pigs for test chemical. The studies are summarized as below –

1. In the study the acute oral toxicity of test compound was determined in white mice by orally administering the test compound in olive oil at doses 1200, 1400,1600,1800,2000 & 2200 mg/kg and observed for clinical signs and mortality for 1 week. The acute oral median lethal dose (LD50) of test chemical in mouse was found to be 2200 mg/kg of body weight (50 percent mortality observed), 80 percent mortality was seen at dose 2000 mg/kg and 10 percent mortality was seen at 1600 & 1800 mg/kg respectively. Thus considering the CLP criteria for classification it can be assessed that the given test chemical is non toxic via oral route as it exceeds the criteria of 2000 mg/kg bw for the substance to be classified as toxic.

2. The acute oral median lethal dose (LD50) of the given test chemical in guinea pig was found to be 3000 mg/kg of body weight. Thus considering the CLP criteria for classification of the substance it can be assessed that the substance does not exhibits acute toxicity by the oral route as it exceeds the criteria of 2000 mg/kg bw for the substance to be classified as toxic.

3. The purpose of this study was to evaluate the toxicity of Anisole on Osborne-Mendel rats. Osborne-Mendel rats were given ionone undiluted at dose of 3700 (3240-4200) mg/kg and observed for 2 weeks for signs of toxicity and mortality. The LD50 value obtained was at 3700 ( (3240-4200) mg/kg with rats showing depression, porphyrin like deposit around eyes, salvation, bloody urine, rough fur. and mortality was observed 4hrs - 8days. From this value it is concluded that the substance Anisole is not toxic to Osborne-Mendel rat by oral route.

4. The assay was conducted to select dose levels for the cytogenetic test. Groups of rats (5/sex/dose) were treated with various dose levels (5000, 2500, 1250, and 625 mg/kg bw) of the test material. The survival of the treated rats was monitored for the next 14 days. Based upon the pattern of mortality, LD50 values of 2937 mg/kg and 4013 mg/kg were estimated for males and females, respectively, by the moving average method.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity:

In different studies, the given test chemical has been investigated for acute inhalation toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below-

1. The 2hr.acute inhalation median lethal concentration (LC50) of anisole in rat was found to be 8949 mg/m3. Acute inhalation toxicity of anisole to rat by inhalative route indicates that the substance does not exhibits acute toxicity by the inhalative route.

2. The acute inhalation median lethal concentration (LC50) of anisole in rat was found to be >5000 mg/m3. Acute inhalation toxicity of anisole to rat by inhalative route indicates that the substance does not exhibits acute toxicity by the inhalative route.

Thus, based on the above summarised studies on test chemical, it can be concluded that LC50 value is >5 mg/L. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity.

Acute Dermal Toxicity:

In different studies, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and rabbits for test chemical. The studies are summarized as below –

1. The test substance was held in continuous 24-hour contact with the shaved skin at the dose level 5.0 ml/kg,2.5ml/kg and 1.25 ml/kg and observed for 14 days. Signs of intoxication were reported as diarrhoea and depression with skin irritation and Eschar formation was observed. LD50 value was assessed to be 2.03 ml/kg (2030 mg/kg).Considering the CLP criteria for classification of the substance the LD 50 value is more than the threshold of 2000 mg/kg for the substance to qualify as toxic. Hence the test chemical was found to be non toxic to rabbit via dermal route.

2. The test substance was applied to the dorsolumbar region under an occlusive patch; so that 10% of the body surface was covered test material remained in contact with the skin for 24 hours. Five rats per dose were tested. Doses ranged from 1-22.2 ml/kg bw was applied. Hemorrhagic lungs were found at necropsy. The LD50 value (and 95% confidence limits) was calculated to be 13.0 (10.3 to 15.4) ml/kg bw((14.3 g/kg or 14300 mg/kg) based on a density of 1.1 g/ml.

3. A dermal LD50 study was conducted in which 5000 mg/kg of Anisole was applied to the skin of rabbits. The animals were observed for mortality and/or systemic effects for 14 days. No further details were provided. Acute dermal LD50/rabbits > 5000 mg/kg bw was determined.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral and acute dermal toxicity; and LC50 value is >5 mg/L (>5000 mg/m3). Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral, acute inhalation and acute dermal toxicity.