2,4,6-trimethylcyclohex-3-enecarbaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 23, 1985 to April 30, 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isocyclocitral, PM 896

IUPAC Name:

Isocyclocitral, PM 896

Test material form:

other: liquid

Details on test material:

Name of test material (as cited in study report): Isocyclocitral, PM 896

Test animals

Species:

mouse

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Method: The animals are placed in individual cages, fasted for four hours and then the animals are individually weighed and intubated with the appropriate volumes of the test material. Each animal on one dosage-level receives the same amount per kg body weight.

4-week old rats or mice are usually used for these tests, in which it is possible to intubate a maximum dosage of 100ml/kg. This high dosage is not normally used, but it is possible to dose up to 40ml/kg without any stress to the animals. this is equivalent to 2.5ml for 60-70g rats, or 0.8ml for 18-22g mice. Substances for test are freshly dissolved in distilled water, saline or groundnut oil, or if insoluble, are supsended in gum tragacanth, gelatin or other suspending agent.

Assessment: The animals are observed for signs of toxicity for 7 days after intubation and any animals dying during this period are autopsied. The results and details of observations after treatment are summarised intable 2 of the study report. After treatment animals are fed a commercial pelleted diet and water ad lib, and survivors are weighed before killing for post-mortem examination at the end of the one week observation period. The approximate LD50 value is estimated from the results and the test substance is given a toxicity rating according to Hodge and Sterner's classsification.

References. H.C.Hodge and J.H.Sterner (1949) Industrial Hygiene Quarterly 10, 93.
Toxicity rating. Toxicity Class. Oral LD50.
1 Extremely toxic < 1mg/kg
2 Highly toxic 1-50 mg/kg
3 Moderately toxic 50-500 mg/kg
4 Slightly toxic 0.5-5 g/kg
5 Practically non-toxic 5-15 g/kg
6 Relatively harmless >15 g/kg

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

One male and one female mouse were dosed at 10 ml/kg
Three males and three females were dosed at 5 ml/kg
One male and one female mouse were dosed at 2 ml/kg
Based on the mortality in the range-finding study, five male and five female rats were treated by gavage with single oral doses of 2.0, 2.4, 2.8, 3.3 and 3.6 grams of the test article administered per kilogram of body weight.

Control animals:

not specified

Details on study design:

Assessment: The animals are observed for signs of toxicity for 7 days after intubation and any animals dying during this period are autopsied. The results and details of observations after treatment are summarised intable 2 of the study report. After treatment animals are fed a commercial pelleted diet and water ad lib, and survivors are weighed before killing for post-mortem examination at the end of the one week observation period. The approximate LD50 value is estimated from the results and the test substance is given a toxicity rating according to Hodge and Sterner's classsification.

References. H.C.Hodge and J.H.Sterner (1949) Industrial Hygiene Quarterly 10, 93.
Toxicity rating. Toxicity Class. Oral LD50.
1 Extremely toxic < 1mg/kg
2 Highly toxic 1-50 mg/kg
3 Moderately toxic 50-500 mg/kg
4 Slightly toxic 0.5-5 g/kg
5 Practically non-toxic 5-15 g/kg
6 Relatively harmless >15 g/kg

Oral intubation 4-5 week old white mice. Groups of white mice were intubated at 3 dose levels using graded volumes of the test substance. Animals were observed for up to 7 days after intubation. All anmals dting were autopsied. All survivors were killed and examined post mortem after 7 days.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

10 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 mL/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 mL/kg bw

Based on:

test mat.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information Toxicity rating 4 (Hodge and Sterner) Criteria used for interpretation of results: EU

Conclusions:

The approximate acute LD50 value was between 2.0 and 5.0 ml/kg body weight.

Executive summary:

The approximate acute LD50 value was between 2.0 and 5.0 ml/kg body weight.