Reaction mass of 1-hydroxydecan-3-one and 3-(hydroxymethyl)nonan-2-one and nonan-2-one

Acute Toxicity: oral

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

Test material information

Constituent 1

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.