Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was conducted in 1977.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Reliability 2 is assigned because although the study was conducted similar to the current OECD TG 401, the guideline is not referenced and there is no documentation on experimental conditions. However, this did not influence the reliability of the results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

1
Chemical structure
Reference substance name:
Reaction mass of 2-[3-(3,3-dimethylcyclohex-1-en-1-yl)propyl]-2-ethyltetrahydrofuran and rel-(3aR,9aR,9bR)-3a-ethyl-6,6,9a-trimethyldodecahydronaphtho[2,1-b]furan and rel-(3aR,9aS,9bS)-3a-ethyl-6,6,9a-trimethyldodecahydronaphtho[2,1-b]furan and rel-2-ethyl-2-{2-[(1R,6R)-2,2,6-trimethylcyclohexyl]ethyl}tetrahydrofuran
Molecular formula:
C17H30O + C17H32O
IUPAC Name:
Reaction mass of 2-[3-(3,3-dimethylcyclohex-1-en-1-yl)propyl]-2-ethyltetrahydrofuran and rel-(3aR,9aR,9bR)-3a-ethyl-6,6,9a-trimethyldodecahydronaphtho[2,1-b]furan and rel-(3aR,9aS,9bS)-3a-ethyl-6,6,9a-trimethyldodecahydronaphtho[2,1-b]furan and rel-2-ethyl-2-{2-[(1R,6R)-2,2,6-trimethylcyclohexyl]ethyl}tetrahydrofuran
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 235-287 g
- Fasting period before study: 16-20 hours
- Housing: 5/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: fresh Purina Rat Chow (Diet #5012), ad libitum, except 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 males/dose
Control animals:
no
Details on study design:
- Frequency of observations: Animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and pharmacological effects.


Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
Clinical signs included diarrhea.
Gross pathology:
Necropsy revealed dark liver and dark kidneys.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified: criteria not met.
Remarks:
According to EU CLP 1272/2008 and its amendments.
Conclusions:
The acute oral toxicity test showed an LD50 greater than 5000 mg/kg bw.
Executive summary:

Acute oral toxicity of Grisalva was studied in rats, performed according to the protocol similar to OECD Guideline 401. Ten male Wistar rats received a single dose of 5000 mg/kg bw by gavage. Animals were observed for 14 days and necropsied. There were no deaths. The only clinical sign was diarrhea. Necropsy revealed dark liver and dark kidneys. Based on the results of the study, LD50 was > 5000 mg/kg bw.Based on the results of this study, the test substance is orally not harmful and does not need to be classified.