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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:
29-07-1980 to 11-08-1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
The information of Constituent 2 is used for read across to Methyl Lavender Ketone.

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)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Nonan-2-one
EC Number:
212-480-0
EC Name:
Nonan-2-one
Cas Number:
821-55-6
Molecular formula:
C9H18O
IUPAC Name:
nonan-2-one

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: At least 9 weeks
- Weight at study initiation: 208 - 235 g
- Fasting period before study: 16 - 20 hours before dosing
- Housing: 5 per cage in suspended wire mesh cages
- Diet: Fresh Purina rat chow, ad libitum
- Water: ad libitum
- Acclimation period: At least one week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed 3-4 hours after dosing and once daily for 14 days. Mortality and clinical signs were recorded.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal died on day 7.
Clinical signs:
All animals were lethargic 3-4 hours post dose. Lethargy was still present in 9 animals on Day 1. Ataxia was noted in 6 animals 3-4 hours post dose. Isolated instances of prostration, flaccid muscle tone, ptosis, tachypnea, lethargy, ataxia, chromorhinorrhea, chromodacryorrhea, and piloerection were noted during the study. One animal had swollen back feet from Days 3 to 6 which developed into partial paralysis due to infection of rear legs from Days 7 to 14.
Gross pathology:
Nine animals, sacrificed on Day 14, were normal. The spontaneous death showed signs of congested and hemorrhagic lungs, dilated heart, stomach and intestines distended and reddish intestines.

Applicant's summary and conclusion

Interpretation of results:
other: not acute harmful
Remarks:
according to EU CLP (EC 1272/2008 and its amendments)
Conclusions:
The substance has an LD50 of > 5000 mg/kg bw in a test similar to OECD TG 401.
Executive summary:

The acute oral toxicity to male rats has been studied similar to OECD TG 401. The substance was administered at a dose of 5000 mg/kg bw to 10 male rats and animals were observed for 14 days. One animal died on day 7. Toxic signs included lethargy, ataxia, prostration, flaccid muscle tone, ptosis, and tachypnea. One animal had swollen back feet and difficulties in walking, probably due to an infection. The internal organs appeared normal except of congested and hemorrhagic lungs, dilated heart, distended stomach and intestines and reddish intestines noted in the animal found dead. The acute oral toxicity (LD50) was determined to be >5000 mg/kg.