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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From February 13, 1979 to February 27, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study performed similarly to OECD guideline 401 with minor deviations: no data on purity, source, no certificate of analysis of the test substance; no details on environmental conditions (humidity, air changes and photoperiod); 10 instead of 5 animals used; weight variations in animals exceed ± 20% of the mean weight; study performed only in male rats
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no data on purity, source, no certificate of analysis of the test substance; no details on environmental conditions; 10 instead of 5 animals used; weight variations in animals exceed ± 20% of the mean weight; study performed only in male rats
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethylocta-1,6-diene
EC Number:
219-433-3
EC Name:
3,7-dimethylocta-1,6-diene
Cas Number:
2436-90-0
Molecular formula:
C10H18
IUPAC Name:
3,7-dimethylocta-1,6-diene
Details on test material:
- Name of test material (as cited in study report): 79-16229, Dihydromyrcene, 0-67-4945
- Physical state: Clear liquid
- Specific gravity: 0.74
- Sample received: December 27, 1979

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: Eight weeks
- Weight at study initiation: 176-331 g
- Fasting period before study: 16-20 hours
- Housing: Animals were housed five/cage in suspended wire mesh cages
- Diet: Fresh Purina rat chow; ad libitum
- Water: Ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21 °C

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality, toxicity and pharmacological effects were observed 3-4 hours after dosing and once daily for 14 days
- Necropsy of survivors performed: Yes; surviving animals were killed and examined grossly
Statistics:
LD50 was calculated according to the method of Litchfield JT and Wilcoxon F, 1949.

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1/10 animal died on Day 7
Clinical signs:
- Lethargy and piloerection were observed in all animals 3-4 hours after dosing; isolated instances of oily anogenital area, lethargy, chromorhinorrhea, chromodacryorrhea, emaciation and ataxia were noted during the early part of study
- All surviving animals were normal throughout the study except an instance of diarrhea on Day 12
Body weight:
No data
Gross pathology:
- Necropsy of animal which died on Day 7 revealed heavily congested and moderately hemorrhagic lungs; moderately dilated heart and a slightly distended stomach containing white fluid mass.
- Necropsy of the surviving animals revealed no abnormalities.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 for Dimethyloctadiene is higher than 5000 mg/kg bw in Wistar rats and therefore it is not classified according to the Annex VI of Directive 67/548/EEC and according to the CLP Regulation (EC) n° 1272/2008.
Executive summary:

In an acute oral toxicity study (limit test) performed similarly to OECD guideline 401, a group of 10 male Wistar rats were given a single oral dose by gavage of Dimethyloctadiene (in the report the synonym Dihydromyrcene was used) at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days and were all macroscopically necropsied after death or sacrifice.

 

Only 1/10 animal died on Day 7. Major signs of toxicity noted after 3-4 hours of dosing in all animals were lethargy and piloerection. Isolated instances of oily anogenital area, lethargy, chromorhinorrhea, chromodacryorrhea, emaciation and ataxia were also noted during the early part of study. All surviving animals were normal from Day 7 to 14 except an instance of diarrhea on Day 12. Necropsy of the animal which died on Day 7 revealed heavily congested and moderately hemorrhagic lungs, moderately dilated heart and a slightly distended stomach containing white fluid mass. Necropsy of the surviving animals revealed no abnormalities.

 

The oral LD50 for Dimethyloctadiene is higher than 5000 mg/kg bw in Wistar rats and therefore it is not classified according to the Annex VI of Directive 67/548/EEC and according to the CLP Regulation (EC) n° 1272/2008.