Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute Oral Toxicity:

The lethal concentration (LD50) value for acute oral toxicity test was considered to be 2900 mg/kg bw(95% C.I. 2380–3540 mg/kg) ,when 50 rats were treated with Cinnamyl formate (104-65-4) orally.

Acute Dermal Toxicity:

The LD50 value was considered to be >5000 mg/kg bw,when 6 rabbits were treated occlusively with Cinnamyl formate (104-65-4) by dermal application for exposure of 24 hours.

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:
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 Cinnamyl formate (104-65-4) on rats.
GLP compliance:
not specified
Test type:
other: No data available
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report):Cinnamyl formate
- Molecular formula :C10H10O2
- Molecular weight :162.187 g/mol
- Substance type:Organic
- Physical state:Colorless to slightly yellow 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:
2000, 2500, 3200, 4000 and 5000 mg/kg/bodyweight
No. of animals per sex per dose:
Total: 50 animals
2000 mg/kg/bw = 10 animals
2500 mg/kg/bw =10 animals
3200 mg/kg/bw =10 animals
4000 mg/kg/bw =10 animals
5000 mg/kg/bw =10 animals
Control animals:
not specified
Details on study design:
Details on study design
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: No data available
- Other examinations performed: Clinical signs
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 900 mg/kg bw
Based on:
test mat.
95% CL:
> 2 380 - < 3 540
Remarks on result:
other: 50% mortality was observed
Mortality:
At 2000 mg/kg bw - 1 rat died.
At 2500mg/kg bw - 4 rats died.
At 3200 mg/kg bw - 7 rats died.
At 4000 mg/kg bw - 9 rats died.
At 5000 mg/kg bw - 9 rats died.
Clinical signs:
Clinical signs like ataxia and mucoid enteritis were observed
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The lethal concentration (LD50) value for acute oral toxicity test was considered to be 2900 mg/kg bw(95% C.I. 2380–3540 mg/kg) ,when 50 rats were treated with Cinnamyl formate (104-65-4) orally.
Executive summary:

Acute Oral Toxicity study was performed in 50 rats using test material Cinnamyl formate (104-65-4). 50% Mortality was observed at dose 2900 mg/kg bw. A majority of the deaths occurred between days 1 and 2.Clinical signs like ataxia and mucoid enteritis were observed. Hence,LD50 value was considered to be 2900 mg/kg bw(95% C.I. 2380–3540 mg/kg),when rats were treated with Cinnamyl formate (104-65-4)orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 900 mg/kg bw
Quality of whole database:
Data is Klimicsh 2

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:
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 Dermal Toxicity test was carried out to study the effects of Cinnamyl formate (104-65-4) on rabbits.
GLP compliance:
no
Test type:
other: No data available
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report):Cinnamyl formate
- Molecular formula :C10H10O2
- Molecular weight:162.187 g/mol
- Substance type:Organic
- Physical state:Colorless to slightly yellow 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:
occlusive
Vehicle:
not specified
Details on dermal exposure:
No data available
Duration of exposure:
Duration of exposure : 24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total: 6 animals = 5000 mg/kg bw
Control animals:
not specified
Details on study design:
Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: No data available
- Other examinations performed: clinical signs
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed in treated rabbits at 5000 mg/kg bw
Mortality:
No mortality was observed in treated rabbits at 5000 mg/kg bw
Clinical signs:
No clinical effects were observed
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 value was considered to be >5000 mg/kg bw,when 6 rabbits were treated occlusively with Cinnamyl formate (104-65-4) by dermal application for exposure of 24 hours.
Executive summary:

In acute dermal toxicity study, 6 Rabbits were treated with Cinnamyl formate (104-65-4) in the concentration of 5000 mg/kg bw by dermal application. No mortality was observed in treated rabbits at dose 5000 mg/kg bw.No clinical effects were observed.Therefore, LD50 value was considered to be >5000 mg/kg bw,when rabbits were treated occlusively with Cinnamyl formate (104-65-4) by dermal application for exposure of 24 hours.

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

Additional information

Acute Oral Toxicity:

In different studies, Cinnamyl formate (104-65-4) has been investigated for acute oral toxicity to a greater or lesser extent. Often the studies are based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats for Cinnamyl formate (104-65-4).The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.

In experimental study conducted by S.P. Bhatia et. al. (Food and Chemical Toxicology 45 (2007) S70–S73); D. Belsito et. al. (Food and Chemical Toxicology 45 (2007) S1–S23); Timothy B. Adamsa et. al. (Food and Chemical Toxicology 42 (2004) 157-185);D. L. J. Opdyke (Food and Cosmetics Toxicology,Volume 14, Supplement, Pages 659-893 (1976)) and U.S. National Library of Medicine (Chemidplus Database,U.S. National Library of Medicine ,2017) for the substance Cinnamyl formate(104-65-4).Acute Oral Toxicity study was performed in 50 rats using test material Cinnamyl formate (104-65-4). 50% Mortality was observed at dose 2900 mg/kg bw. A majority of the deaths occurred between days 1 and 2.Clinical signs like Ataxia and mucoid enteritis were observed. Hence,LD50 value was considered to be 2900 mg/kg bw(95% C.I. 2380–3540 mg/kg),when rats were treated with Cinnamyl formate (104-65-4)orally.

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for Cinnamyl formate(104-65-4) .The LD50 was estimated to be 2086.60 mg/kg bw,when male and female Wistar rats were orally exposed with Cinnamyl formate(104-65-4) via gavage.

Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 was estimated to be 2700 mg/kg bw on rats for Cinnamyl formate(104-65-4) having Reliability Index: 0.81 (moderate prediction quality).

Also these results are further supported by the experimental study conducted by S.P. Bhatia et. al. (Food and Chemical Toxicology 45 (2007) S70–S73); D. L. J. Opdyke (Food and Cosmetics Toxicology,Volume 14, Supplement, Pages 659-893 (1976));Belsito et. al. (Food and Chemical Toxicology 45 (2007) S1–S23); and .S. National Library of Medicine (Chemidplus Database,U.S. National Library of Medicine ,2017) for the structurally similar read across substance Cinnamyl acetate (103-54-8).In acute-oral toxicity study ,the toxic effects of cinnamyl acetate were assessed in group of 10 rats by oral route in the concentration of 1460, 2220, 3330 and 5000 mg/kg/bodyweight.Observations were made for 14 days.No deaths occurred at the 1460 mg/kg ,1/10 deaths occurred at 2220 m g/kg; 6/10 deaths at 3330 mg/kg and 10/10 at 5000 mg/kg .All deaths occurred within the first 48 h.Clinical signs observed during the study included slow respiration, lethargy, depression and coarse tremors in high doses.Therefore,LD50 value is considered to be 3300mg/kg body weight(95% C.I. 2900–3700 mg/kg),when rats were exposed to Cinnamyl acetate (103-54-8) by oral route .

Thus, based on the above studies and predictions on Cinnamyl formate (104-65-4) and its read across substances, it can be concluded that LD50 value was 2086 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Cinnamyl formate (104-65-4) can be “Not classified” for Acute Oral Toxicity.

Acute Dermal Toxicity:

In different studies, Cinnamyl formate (104-65-4) has been investigated for acute dermal toxicity to a greater or lesser extent. Often the studies are based on in vivo experiments and estimated data in rodents, i.e. most commonly in rabbits for Cinnamyl formate (104-65-4).

In experimental study conducted by S.P. Bhatia et. al. (Food and Chemical Toxicology 45 (2007) S70–S73); D. L. J. Opdyke (Food and Cosmetics Toxicology,Volume 14, Supplement, Pages 659-893 (1976)) and D. Belsito et. al.(Food and Chemical Toxicology 45 (2007) S1–S23) for the substance Cinnamyl formate (104-65-4). In acute dermal toxicity study, 6 Rabbits were treated with Cinnamyl formate (104-65-4) in the concentration of 5000 mg/kg bw by dermal application. No mortality was observed in treated rabbits at dose 5000 mg/kg bw. No clinical effects were observed. Therefore, LD50 value was considered to be >5000 mg/kg bw, when rabbits were treated occlusively with Cinnamyl formate (104-65-4) by dermal application for exposure of 24 hours.

Also these results are further supported by the experimental study conducted by S.P. Bhatia et. al. (Food and Chemical Toxicology 45 (2007) S70–S73); D. L. J. Opdyke(Food and Cosmetics Toxicology,Volume 14, Supplement, Pages 659-893 (1976) ) and D. Belsito et. al. Food and Chemical Toxicology 45 (2007) S1–S23 ) for the structurally similar read across substance Cinnamyl acetate (103-54-8). In acute-oral toxicity study ,the toxic effects of cinnamyl acetate (103-54-8) were assessed in group of 10 rats by oral route in the concentration of 1460, 2220, 3330 and 5000 mg/kg/bodyweight. Observations were made for 14 days. No deaths occurred at the 1460 mg/kg ,1/10 deaths occurred at 2220 m g/kg; 6/10 deaths at 3330 mg/kg and 10/10 at 5000 mg/kg .All deaths occurred within the first 48 h. Clinical signs observed during the study included slow respiration, lethargy, depression and coarse tremors in high doses.Therefore,LD50 value is considered to be 3300mg/kg body weight(95% C.I. 2900–3700 mg/kg),when rats were exposed to Cinnamyl acetate (103-54-8)by oral route .

Thus, based on the above studies on Cinnamyl formate (104-65-4),it can be concluded that LD50 value was >5000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Cinnamyl acetate(103-54-8) can be “Not classified” for Acute Dermal Toxicity.

Justification for classification or non-classification

 Thus, comparing this value with the criteria of CLP regulation, Cinnamyl formate (104-65-4) can be “Not classified” for Acute Oral and Dermal Toxicity.