Mentha citrata, ext.

Acute Toxicity: oral

Administrative data

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 authoritative database

Data source

Reference

Reference 1

Reference Type:

other: authoritative database

Title:

Acute oral toxicity study of test chemical in rat

Author:

U.S. National Library of Medicine

Year:

2017

Bibliographic source:

Chemidplus Database,U.S. National Library of Medicine,2017

Reference 2

Reference Type:

other: authoritative database

Title:

Acute oral toxicity study of test chemical in rat

Author:

US national Library of Medicine

Year:

2018

Bibliographic source:

HSDB (Hazardous Substances Data Bank); US national Library of Medicine,2018

Reference 3

Reference Type:

publication

Title:

Acute oral toxicity study of test chemical in rat

Author:

D. L. J. Opdyke

Year:

1964

Bibliographic source:

Food and Cosmetics Toxicology

Reference 4

Reference Type:

publication

Title:

Acute oral toxicity study of test chemical in rat

Author:

P. M. JENNER et. al.

Year:

1964

Bibliographic source:

Fd Cosmet. Toxicol

Reference 5

Reference Type:

other: authoritative database

Title:

Acute oral toxicity study of test chemical in rat

Author:

U.S. National Library of Medicine

Year:

2018

Bibliographic source:

HSDB (Hazardous Substances Data Bank); US national Library of Medicine,2018

Reference 6

Reference Type:

secondary source

Title:

Acute oral toxicity study of test chemical in rat

Author:

United Nations Environmental Programme (UNEP)

Year:

2002

Bibliographic source:

SIDS Initial Assessment Report For Linalool, United Nations Environmental Programme (UNEP)

Reference 7

Reference Type:

secondary source

Title:

Acute oral toxicity study of test chemical

Author:

HPVIS

Year:

2018

Bibliographic source:

HPVIS,2018

Reference 8

Reference Type:

publication

Title:

Acute oral toxicity study of test chemical in rat

Author:

D. Belsito et. al.

Year:

2008

Bibliographic source:

Food and Chemical Toxicology

Materials and methods

Test guideline

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 rats.

GLP compliance:

not specified

Test type:

other: no data available

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Linalool

EC Number:

201-134-4

EC Name:

Linalool

Cas Number:

78-70-6

Molecular formula:

C10H18O

IUPAC Name:

(3S)-3,7-dimethylocta-1,6-dien-3-ol

Test material form:

liquid

Details on test material:

- Name of test material (IUPAC name): (3S)-3,7-dimethylocta-1,6-dien-3-ol
- Common name: Linalool
- Molecular formula: C10H18O
- Molecular weight: 154.251 g/mol
- Smiles notation: C([C@@](C=C)(C)O)C\C=C(\C)C
- InChl: 1S/C10H18O/c1-5-10(4,11)8-6-7-9(2)3/h5,7,11H,1,6,8H2,2-4H3
- Substance type: Organic
- Physical State: Liquid

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data available

Doses:

2790 mg/kg bw

No. of animals per sex per dose:

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

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: 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

Statistics:

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

Results and discussion

Preliminary study:

no data available

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 790 mg/kg bw

Based on:

test mat.

95% CL:

2 440 - 3 180

Remarks on result:

other: 50% mortality was observed

Mortality:

Death occurred within 4-18 hours after treatment.

Clinical signs:

In clinical signs observations, Behavioral ataxia (soon after Treatment) was observed

Body weight:

No data available

Gross pathology:

No data available

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The lethal concentration (LD50) value for acute oral toxicity test 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.

Executive summary:

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 be2790 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.