Juniper, Juniperus mexicana, ext., epoxidized

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 10 to 24, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-guideline and pre-GLP study. Only basic data given but the study is comparable to OECD TG 401.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

No details on environmental conditions of animal room.

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Juniper, Juniperus mexicana, ext., epoxidized

EC Number:

309-066-8

EC Name:

Juniper, Juniperus mexicana, ext., epoxidized

Cas Number:

99811-75-3

Molecular formula:

not applicable (UVCB substance)

IUPAC Name:

(1S,2R,5S,7R)-2,6,6,8-tetramethyltricyclo[5.3.1.0¹,⁵]undecan-9-one; (1aS,2R,4aS,8aS)-2,4a,8,8-tetramethyl-decahydrocyclopropa[e]naphthalen-3-one; (1aS,2S,4aS,8aS)-2,4a,8,8-tetramethyl-decahydrocyclopropa[e]naphthalen-3-one

Test material form:

not specified

Details on test material:

No data

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: Rats were deprived of food but not water for 24 h prior to dosing.
- Diet: Food, ad libitum
- Water: Water, ad libitum

IN-LIFE DATES: From July 10 to 24, 1979

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
Animals were observed for mortality and clinical signs daily for 14 days. Initial and final bodyweights of animals were recorded.
- Necropsy of survivors performed: Yes; animals were subjected to gross necropsy.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical signs related to test material were observed.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Rat Oral LD50 Combined > 5000 mg/kg bw

Executive summary:

In an acute oral toxicity study (limit test) performed similarly to OECD guideline 401, groups of rats (5/sex) were administered a single oral dose of test material at 5000 mg/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

No mortality or clinical signs were observed. All animals showed expected gains in bodyweight over the 14 day study period. No abnormalities were noted at necropsy.

 

Oral LD50 Combined > 5000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP). 

 

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.