Mentha citrata, ext.

Endpoint summary

Description of key information

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Mentha citrata, ext. (85085-49-0).The studies are as mentioned below:

1.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 2790 mg/kg bw.Death occurred within 4-18 hours after treatment. In clinical signs observations, Behavioral ataxia (soon after Treatment) was observed.Hence,LD50 value was considered to be 2790 mg/kg bw(95% C. I.: 2440-3180 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.

2.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 14550 mg/kg bw.In clinical signs observations,animals showed depression soon after treatment, coma and wet posterior.Hence,LD50 value was considered to be14550 mg/kg bw(95 %C. I.: 12,300-17,170 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.

Thus, based on the above summarised studies,Mentha citrata, ext. (85085-49-0) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Mentha citrata, ext. (85085-49-0) cannot be classified for acute oral toxicity.Hence, based on the data available for the structurally similar read across, test chemical

Mentha citrata, ext. (85085-49-0) is not likely to be toxic at the dose of 14550 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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 of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across 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 report is based on two acute oral toxicity studies as-
1.and 2. Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Specific details on test material used for the study:

- Name of test material : Mentha citrata, ext.
- IUPAC name : Mentha citrata, ext.
- Molecular formula : Unspecified
- Molecular weight : Unspecified g/mol
- Substance type: Organic
- Physical state: Clear liquid (Colorless to slight yellow)

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

1.Details on test animal
TEST ANIMALS
- Age at study initiation: young adult rats
- Fasting period before study:18 hours
- Diet (e.g. ad libitum): the food was replaced in cages as soon as the animals received their
respective doses.
- Water (e.g. ad libitum):water was provided ad libitum

2.Details on test animal
TEST ANIMALS
- Age at study initiation: young adult rats
- Fasting period before study:18 hours
- Diet (e.g. ad libitum): the food was replaced in cages as soon as the animals received their
respective doses.
- Water (e.g. ad libitum):water was provided ad libitum

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data available

Doses:

1.2790 mg/kg bw
2.14550 mg/kg bw

No. of animals per sex per dose:

1.Total: 10 animals
2790 mg/kg bw: 5 males and 5 females


2.Total: 10 animals
2790 mg/kg bw: 5 males and 5 females

Control animals:

not specified

Details on study design:

1.Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were maintained under close observation for toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks.
- Other examinations performed: clinical signs


2.Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were maintained under close observation for toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain.
- Other examinations performed: clinical signs

Statistics:

LD50s were computed by the method of Litchfield & Wilcoxon (1949).

Preliminary study:

no data available

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 790 - < 14 550 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed

Mortality:

1.Death occurred within 4-18 hours after treatment.
2.50% mortality was observed at dose 14550 mg/kg bw

Clinical signs:

1.In clinical signs observations, Behavioral ataxia (soon after Treatment) was observed
2.In clinical signs observations,animals showed depression soon after treatment, coma and wet posterior.

Body weight:

No data available

Gross pathology:

No data available

Other findings:

No data available

Interpretation of results:

other: not classified

Conclusions:

According to CLP regulation, the test chemical Mentha citrata, ext. (85085-49-0) cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw i.e. in the dose of 14550 mg/Kg bw.

Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Mentha citrata, ext. (85085-49-0).The studies are as mentioned below:

1.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 2790 mg/kg bw.Death occurred within 4-18 hours after treatment. In clinical signs observations, Behavioral ataxia (soon after Treatment) was observed.Hence,LD50 value was considered to be 2790 mg/kg bw(95% C. I.: 2440-3180 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.

2.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 14550 mg/kg bw.In clinical signs observations,animals showed depression soon after treatment, coma and wet posterior.Hence,LD50 value was considered to be14550 mg/kg bw(95 %C. I.: 12,300-17,170 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.

Thus, based on the above summarised studies,Mentha citrata, ext. (85085-49-0) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Mentha citrata, ext. (85085-49-0) cannot be classified for acute oral toxicity.Hence, based on the data available for the structurally similar read across, test chemical

Mentha citrata, ext. (85085-49-0) is not likely to be toxic at the dose of 14550 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

14 550 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from peer-reviewed journal

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Mentha citrata, ext. (85085-49-0).The studies are as mentioned below:

1.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 2790 mg/kg bw.Death occurred within 4-18 hours after treatment. In clinical signs observations, Behavioral ataxia (soon after Treatment) was observed.Hence,LD50 value was considered to be 2790 mg/kg bw(95% C. I.: 2440-3180 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.

2.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 14550 mg/kg bw.In clinical signs observations,animals showed depression soon after treatment, coma and wet posterior.Hence,LD50 value was considered to be14550 mg/kg bw(95 %C. I.: 12,300-17,170 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period.

Thus, based on the above summarised studies,Mentha citrata, ext. (85085-49-0) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Mentha citrata, ext. (85085-49-0) cannot be classified for acute oral toxicity.Hence, based on the data available for the structurally similar read across, test chemical

Mentha citrata, ext. (85085-49-0) is not likely to be toxic at the dose of 14550 mg/kg bw.

Justification for classification or non-classification

Based on the above experimental studies on Mentha citrata, ext. (85085-49-0)and it’s structurally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Mentha citrata, ext. (85085-49-0)cannot be classified for acute oral toxicity.