Reaction Mass of 3,8-dimethyl-5-(prop-1-en-2-yl)-1,2,3,3a,4,5,6,7-octahydroazulene and 4,8a,9,9-octamethyldecahydro-1,6-methanonaphthalen-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 June 1988 to 16 November 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

not applicable

Principles of method if other than guideline:

A group of six rats (3 males and 3 females) was treated at 2.0 g/kg bodyweight and, based on the result of that dosing, a further group of six rats was dosed at 5.0 g/kg.

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of 3,8-dimethyl-5-(prop-1-en-2-yl)-1,2,3,3a,4,5,6,7-octahydroazulene and 4,8a,9,9-octamethyldecahydro-1,6-methanonaphthalen-1-ol

EC Number:

947-570-5

Molecular formula:

Not applicable

IUPAC Name:

Reaction Mass of 3,8-dimethyl-5-(prop-1-en-2-yl)-1,2,3,3a,4,5,6,7-octahydroazulene and 4,8a,9,9-octamethyldecahydro-1,6-methanonaphthalen-1-ol

Test material form:

liquid

Details on test material:

- Physical state: clear amber liquid
- Storage condition of test material: ambient temperature in the dark

Specific details on test material used for the study:

see confidential

Test animals

Species:

rat

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, England
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 108-142 g
- Fasting: overnight prior to dosing and for approximately 4 hours after dosing.
- Housing: grouped by sex in metal cages with wire mesh floors.
- Diet: Standard laboratory rodent diet (Labsure LAD-1) ad libitum (see Appendix 1, attached)
- Water: ad libitum (see Appendix 2, attached, for results of routine chemical examination of water at source (Grafham Final Water) as conducted by Anglian Water Authority)
- Acclimation period: 8 days prior to start of study

ENVIRONMENTAL CONDITIONS
- Temperature: 21-24 ºC
- Humidity: mean value 67 %
- Air changes: approximately 15 per hour
- Photoperiod: controlled by a time switch to provide 12 hours artificial light in each 24 hour period.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The appropriate dose volume of the test substance was administered to each rat using a syringe and plastic catheter (8 choke)

Doses:

Single doses

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Each animal was identified by cage number and ear punching.
- Each cage was identified by a coloured label displaying the dose level, study schedule number and the initials of the study director.
- Animals were observed soon after dosing and at frequent intervals for the remainder of day one (a minimum period of five hours).
- On subsequent days the animals were observed once in the morning and again at the end of the experimental day.
- The latter observation was at approximately 16:30 hours on weekdays or 11:30 hours on Saturday and Sunday.
- Clinical signs were recorded at each observation.
- All animals were observed for 14 days after dosing.
- Nature, severity, approximate time of onset and duration of each toxic sign was recorded.
- Individual bodyweights of rats were recorded on days 1, 8 and 15.
- All animals were killed on day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination, which consisted of opening the abdominal and thoracic cavities.
- Macroscopic appearance of abnormal organs when present was recorded.

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mg/kg bw

Mortality:

No deaths took place following administration of test material at 2.0 or 5.0 g/kg bodyweight

Clinical signs:

other: - All rats showed pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethergy and increased salivation within three hours of dosing (refer to Table 1, attached). - Decreased respiratory rate was seen in all rats treated wit

Gross pathology:

- Terminal autopsy findings were normal.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute median lethal oral dose (LD50) to rats of the test material was found to be > 5.0 g/kg bodyweight.

Executive summary:

The acute median lethal oral dose (LD50) to rats of the test material was found to be > 5.0 g/kg bodyweight.