Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
other: 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
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).