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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
p-mentha-1,3-diene
EC Number:
202-795-1
EC Name:
p-mentha-1,3-diene
Cas Number:
99-86-5
Molecular formula:
C10H16
IUPAC Name:
1-isopropyl-4-methylcyclohexa-1,3-diene
Test material form:
liquid
Details on test material:
Clear colourless liquid.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Alpha Terpinene, 72-227
- Purity test date: not specified
- Type: Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS - rats

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
VEHICLE - not specified
Doses:
5 doses tested: 1.05, 1.31, 1.64, 2.05 and 5 g/kg
No. of animals per sex per dose:
10 animals per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: not specifed
- Other examinations performed: clinical signs
Statistics:
LD50 calculation

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 1.68 other: g/kg
Based on:
not specified
95% CL:
ca. 1.46 - ca. 1.9
Mortality:
Mortality was observed on day 1 at 1.31, 1.64, 2.05 and 5 g/kg in four, one, three and eight rats, respectively.
On day 2, the deaths were observed at dose levels: 1.64 g/kg (two animals) and at 2.05 g/kg (four animals) as well as at dose 5 g/kg (remaining two rats)
In additon, on day 4, one rat was found dead (dose level: 1.64 g/kg). Also, on day 10 there was a mortality observed in one rat at dose level of 2.05 g/kg.
Clinical signs:
The clinical signs depended on the dose tested

1.05 g/kg - no clinical signs
1.31 g/kg - lethargy
1.64 g/kg - lethargy
2.05 g/kg - lethargy, loss of righting reflex, piloerection
5 g/kg - lethargy, loss of righting reflex, piloerection

Body weight:
not specified
Gross pathology:
not specified

Any other information on results incl. tables

Table 1. Distribution of mortality

Group number

Dose Level

(g/Kg)

Deaths/ number of animals

Observation days

1

2

3

4

5

6

7

8

9

10

11

12

13

14

1

1.05

0/10

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

1.31

4/10

4

0

0

0

0

0

0

0

0

0

0

0

0

0

3

1.64

4/10

1

2

0

1

0

0

0

0

0

0

0

0

0

0

4

2.05

8/10

3

4

0

0

0

0

0

0

0

1

0

0

0

0

5

5

10/10

8

2

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the reults the LD50 was claculated to be 1.68 g/kg (1.46 - 1.90). Alpha terpinene is classifed as oral acute tox, category 4 accroding to GHS/EU CLP.
Executive summary:

In this study, an on oral acute toxicity was conducted in the rat using alpha terpinene.

 

Ten rats per treatment were exposed to the following doses: 1.05, 1.31, 1.64, 2.05 and 5 g/kg. Rats were observed for 14 days.

 

No clinical findings and deaths occurred in the lowest tested dose (1.05 g/kg). Lethargy was observed on the day of dosing in rats dosed at 1.31, 1.64, 2.05 and 5 g/kg. The rats dosed at 2.05 and 5 g/kg exhibited loss of righting reflex and piloerection.

 

The exposure to the middle doses (1.31 and 1.64 g/kg) caused 40% of death. 80% of death animals were found at 2.05 g/kg within 10 days after a single exposure.

 

The highest dose caused 100% of death after 24 hrs. (8 deaths) and 48 hrs (2 deaths), respectively.

 

Based on the results the LD50 was calculated to be 1.68 g/kg (1.46 - 1.90).