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EC number: 202-795-1 | CAS number: 99-86-5
Acute Toxicity: oral
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:
- 1 973
- 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
- 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.
Constituent 1
- 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).
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