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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been presented as 2 because of read across and because similar to OECD Guideline protocol has been followed but not GLP.

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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
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:
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 into severe depression and looked anoxic. No stimulation was seen. Animals never did fully recover, even at the end of 14 days.
Body weight:
Anorexia was seen at all levels and, although the animals were not weighed at termination of study, most appeared to have lost weight.

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:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An LD50 of 4300 mg/kg bw was obtained in the acute oral toxicity study with 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 = 2.9 -5.7) was determined.