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Diss Factsheets

Administrative data

Description of key information

Acute toxicity: oral

The acute oral median lethal dose (LD50) of anisyl formate in rat was observed to be 1150.0 mg/kg b.wt.

Acute toxicity: dermal

The acute dermal LD50 of test compound Anisyl formate in rabbit was found to be more than 5000mg/kg b.wt. (> 5000 mg/kg b.wt.).

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)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer-reviewed journal
Qualifier:
according to guideline
Guideline:
other: refer below
Principles of method if other than guideline:
The acute toxicity study was conducted to evaluate the toxic effects of administration of Anisyl formate (CAS No. 122-91-8) in rat by the oral route.
GLP compliance:
not specified
Test type:
other: No data available
Limit test:
no
Specific details on test material used for the study:
- Name of test material: (4-methoxyphenyl)methyl formate
- Molecular formula: C9H10O3
- Molecular weight: 166.175 g/mol
- Smiles notation: c1(ccc(OC)cc1)COC=O
- InChl: 1S/C9H10O3/c1-11-9-4-2-8(3-5-9)6-12-7-10/h2-5,7H,6H2,1H3
- Substance type: Organic
- Physical state: Liquid
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
No data available
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 150 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality observed.
Mortality:
No data available
Clinical signs:
other: No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
other: Category 4 based on CLP criteria
Conclusions:
The acute oral median lethal dose (LD50) of anisyl formate in rat was observed to be 1150.0 mg/kg b.wt.
Executive summary:

The acute toxicity study was conducted to evaluate the toxic effects of administration of Anisyl formate (CAS No. 122-91-8) in rat by the oral route. 50% mortality was observed at 1150.0 mg/kg b.wt in treated rats. The acute oral median lethal dose (LD50) of anisyl formate in rat was observed to be 1150.0 mg/kg b.wt. Thus, by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that Anisyl formate (CAS No. 122 -91-8) can be classify under category 4 compound at the tested dose levels.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 150 mg/kg bw
Quality of whole database:
The data is K2 level and from a peer-reviwed journal.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Data is from peer-reviewed journal
Qualifier:
according to guideline
Guideline:
other: refer below
Principles of method if other than guideline:
The acute toxicity study was conducted to evaluate the toxic effects of administration of Anisyl formate (CAS No. 122-91-8) in rabbit by the dermal route.
GLP compliance:
not specified
Test type:
other: No data available
Limit test:
no
Specific details on test material used for the study:
- Name of test material: (4-methoxyphenyl)methyl formate
- Molecular formula: C9H10O3
- Molecular weight: 166.175 g/mol
- Smiles notation: c1(ccc(OC)cc1)COC=O
- InChl: 1S/C9H10O3/c1-11-9-4-2-8(3-5-9)6-12-7-10/h2-5,7H,6H2,1H3
- Substance type: Organic
- Physical state: Liquid
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data available
Duration of exposure:
No data available
Doses:
No data available
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality was observed.
Mortality:
No data available
Clinical signs:
other: No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
other: Not classified based on CLP criteria
Conclusions:
The acute dermal LD50 of test compound Anisyl formate in rabbit was found to be more than 5000mg/kg b.wt. (> 5000 mg/kg b.wt.).
Executive summary:

The acute toxicity study was conducted to evaluate the toxic effects of administration of Anisyl formate (CAS No. 122-91-8) in rabbit by the dermal route. The acute dermal LD50 of test compound Anisyl formate was found to be more than 5000mg/kg b.wt. (> 5000 mg/kg b.wt.). Thus, according to CLP criteria for acute toxicity rating for the chemicals, the test compound Anisyl formate (CAS No. -122-91-8) can be classify under non toxic category at the tested dose level of 5000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
The data is K2 level and from a peer-reviwed journal.

Additional information

Acute toxicity: oral

In different studies, anisyl formate (CAS No.122-91-8) 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 for anisyl formate along with the study available on structurally similar read across substance anisaldehyde/p-methoxybenzaldehyde (CAS No. 123-11-5) and vanillin (CAS No. 121-33-5). The predicted data using the OECD QSAR toolbox has also been compared with the experimental data. The studies are summarized as below:

 

The acute toxicity study published in a peer-reviewed journal (Food and Cosmetics Toxicology Volume 14, Supplement, 1976, Page 685); in which the toxic effects of administration of Anisyl formate (CAS No. 122-91-8) in rat by the oral route was examined. 50% mortality was observed at 1150.0 mg/kg b.wt in treated rats. The acute oral median lethal dose (LD50) of anisyl formate in rat was observed to be 1150.0 mg/kg b.wt.

 

The above acute oral toxicity study is supported by another experimental study given by Levenstein, I. (1975); in which the study was conducted to evaluate the toxic effects of administration of Anisyl formate (CAS No. 122-91-8) in rat by the oral route. 50% mortality was observed at 1800.0 mg/kg b.wt in treated rats.The acute oral median lethal dose (LD50) of anisyl formate in rat was observed to be 1800.0 mg/kg b.wt.

 

Also the acute toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017); to evaluate the toxic effects of administration of anisyl formate (CAS No. 122-91-8) in rat by the oral route. 50% mortality was observed. Thus, the acute oral median lethal dose (LD50) of Anisyl formate in rat was estimated to be 858.28 mg/kg b.wt.

 

This is further supported by the study published in a peer reviewed journal (P. M. Jenner, e. C. Hagan, jean m. Taylor, e. L. Cook and o. G. Fitzhugh,Food Flavourings and Compounds of Related Structure I. Acute Oral Toxicity, Fd Cosmet. Toxicol. Vol. 2, pp. 327-343, 1964.); in which the acute toxicity study was conducted to evaluate the toxic effects of administration of anisaldehyde/p-methoxybenzaldehyde (CAS No. 123-11-5) in rat by the oral route. Groups of 10 young adult Osborne-Mendel rats evenly divided by sex were fasted for approximately 18 hr prior to treatment. Oral dosage of anisaldehyde was administered by intubation to the rats. Animals were observed usually for 2 weeks during which time the development of toxic signs was followed and time of death recorded. The acute oral LD50 was determined. Depression was observed and death time was recorded as 4-18 hours. The acute oral median lethal dose (LD50) of anisaldehyde in rat was observed to be 1510.0 mg/kg b.wt with 95% confidence limit of 1360.0 – 1700.0 mg/kg.

 

Moreover in a study by Jean m. Taylor et. al (Toxicology and applied pharmacology 6, 378-387,1964), the acute oral toxicity of vanillin was determined in rats of the Osborne-Mendel or Sherman strain. The compound was administered by stomach tube to rats fasted 18 hours. A group of five males and five female rats were used. The rats were observed until the survivors had returned to normal in appearance and weight during which time the development of toxic signs was followed and time of death recorded. Comatose soon after treatment, scrawny appearance for several days and death time was recorded as 4 hours to 4 days. The acute oral median lethal dose (LD50) of vanillin in rat was observed to be 1580.0 mg/kg b.wt with 95% confidence limit of 1390.0 – 1810.0 mg/kg.

 

So, based on the above mentioned studies for target substance Anisyl formate (CAS No. 122-91-8) and to its read across substance, the median lethal dose (LD50) value was found to be in the range of 858.28 mg/kg bw to 1800.0 mg/kg b.wt. Thus, by comparing these studies with the criteria of CLP regulation, it infers that anisyl formate (CAS No. 122-91-8) can be classify under category 4 compound at the tested dose levels.

 

Acute toxicity: dermal

A study published in a peer-reviewed journal (Food and Cosmetics Toxicology Volume 14, Supplement, 1976, Page 685.); in which the acute toxicity study was conducted to evaluate the toxic effects of administration of Anisyl formate (CAS No. 122-91-8) in rabbit by the dermal route. The acute dermal LD50 of test compound Anisyl formate was found to be more than 5000mg/kg b.wt. (> 5000 mg/kg b.wt.). Thus, according to CLP criteria for acute toxicity rating for the chemicals, the test compound Anisyl formate (CAS No. -122-91-8) can be classify under non toxic category at the tested dose level of 5000 mg/kg body weight.

Justification for classification or non-classification

Based on the above mentioned studies on Anisyl formate (CAS No. – 122-91-8), it can be found that LD50 oral value is in the range of 300 to ≤2000 mg/kg b.wt and LD50 dermal value is >2000 mg/kg b.wt. Thus, by comparing these studies with the criteria of CLP regulation, it infers that the test substance anisyl formate (CAS No. -122-91-8) can be classify as an acute oral toxicant in category 4 whereas anisyl formate does not classify as an acute toxicant by the dermal route.