Terpene hydrocarbon alcohols, terpene processing by-products

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

non-GLP

Justification for type of information:

This information is used for read-across to Terpene hydrocarbon alcohols

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Four groups of each 10 male ablino (Wistar) rats were orally exposed to 2, 4, 8 and 16 g/kg bw Terpineol. They were observed for signs of toxicity and pharmacological effects at 1, 6 and 24 hours and daily thereafter for a period of 14 days. An LD50 was calculated.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Terpineol multi: 8000-41-7

IUPAC Name:

Terpineol multi: 8000-41-7

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Terpineol and Dertol 90

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-225 gram
- Fasting period before study: Minimum of 16 hours before dosing

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

2000, 4000, 8000 and 16000 mg/kg

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

Four groups of each 10 male ablino (Wistar) rats were orally exposed to 2, 4, 8 and 16 g/kg bw Terpineol. They were observed for signs of toxicity and pharmacological effects at 1, 6 and 24 hours and daily thereafter for a period of 14 days. An LD50 was calculated.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

4 300 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 900 - <= 5 700

Mortality:

Deaths in most cases occurred overnight or later. See "any other information results"

Clinical signs:

other: The animals appeared depressed or lethargic throughout the study. In several cases towards the end of the study, inner ear syndrome appeared but this was thought to be a drug effect since it is not uncommon in rats. Animals dying the day of dosing went in

Any other information on results incl. tables

Deaths per day after exposure to terpineol

Dose mg/kg	Deaths/day	total
2000	2/2, 1/4, 1/6	4/10
4000	1/2, 3/3, 1/5	5/10
8000	8/2	8/10
16000	10/3	10/10

Applicant's summary and conclusion

Interpretation of results:

other: Not acutely harfmul

Remarks:

according to EU CLP (EC No. 1272/2008 and its amendments).

Conclusions:

The oral acute toxicity is 4300 mg/kg bw in male rats.

Executive summary:

In an acute oral toxicity study 4 groups of 10 male albino Wistar rats were orally exposed to 2000, 4000, 8000 and 16000 mg/kg bw of Terpineol multi. They were observed for signs of toxicity and pharmacological effects at 1, 6 and 24 hours and daily thereafter for a period of 14 days. Deaths in most cases occurred overnight or later and the animals appeared depressed or lethargic throughout the study. Anorexia was seen at all levels and, although the animals were not weighed at terminationof study, most appeared to have lost weight. In several cases towards the end of the study, inner ear syndrome appeared which is not uncommon in rats. Animals dying the day of dosing went into severe depression and looked anoxic. No stimulation was seen. A LD50 of 4300 mg/kg bw (95% CI = 2900 -5700 mg/kg bw) was determined.