3,5,5-trimethylhexanal

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1996 until May 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,5,5-trimethylhexanal

EC Number:

226-603-0

EC Name:

3,5,5-trimethylhexanal

Cas Number:

5435-64-3

Molecular formula:

C9H18O

IUPAC Name:

3,5,5-trimethylhexanal

Details on test material:

Date of production: February/March 1996
Properties: clear, colourless, visually homogeneous liquid
Stability: > 1 year
Expiry date: March 1997
Purity: 91,2 mass-% (gaschromatographic analysis)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

healthy, young adult animals/weight variation did not exceed +/- 20 % of the mean body weight

rat, Wistar (HsdCpb:WU/SPF)

Housing:
Animals were housed in Markolon type III cages, group caged by sex, each cage containing max. five rats

Acclimatization:
Animals were acclimatized for at least five days.

Room temperature: 22 +/- 3 ° C
Relative humidity: 30 - 70 %

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

A single oral application of the test substance was given.
The undiluted litquid test substance was administered by gavage using a stomach tube with an application volume at 2.44 cm³/kg bodyweight.

Doses:

2000 mg/kg bodyweight (2.44 cm³/kg bodyweight)

No. of animals per sex per dose:

ten rats ( five males and five females)

Control animals:

no

Details on study design:

Approximately 16 hours before treatment the animals were starved.
In the first instance two male and two female rats were given a single oral application of the test substance at a dose level of 2000 mg/kg/bodyweight.Since no mortalities occured within 24 hours p.a., three male and three female rats were treated in the same way.

The dosing formulation was applied to the rats by gavage using a stomach tube (2.44 cm³/kg/bodyweight).

The day of dosing was deginated day 0.

No control animyls were included in this study.

Results and discussion

Preliminary study:

No preliminary study, 2000 mg/kg was used as the fixed dose.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000

Remarks on result:

other: Fixed dose test

Mortality:

One female rat died following a singe oral application at 2000 mg/kg bodyweight.

Clinical signs:

other: All animals showed severe clinical symptoms within the first six hours after treatment with the test substance. Symptoms like sedation, padding movements, gait abnormality, piloerection, tremor, impaired coordination, loss of weight, squatting and abdomin

Gross pathology:

The macroscopic examination of the female animal found dead 72 hours after application of the test substance showed emaciation, autolytic
changes, lesions caused by cannibalism, hyperaemia of the gastric mucosa and the lung and lung emphysema.
The animals killed on day 14 showed thickening and induration of the mucosa of the forestormach.
No other abnormalities were observed in these
animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

no classification according to CLP Regulation (EC) No. 1272/2008

Executive summary:

A study(limit test) was performed to assess the acute oral toxicity of 3,5,5 -Triomethylhexanal to the rat. A group of ten rats (five males and five females) was given a single oral application of the test substance at a dose level of 2000 mg/kg bodyweight (bw). The undiluted liquid test substance was administered by gavage using a stomach tube with an application volume at 2.44 cm³/kg bodyweight.

All animals showed severe clinical symptoms within the first six hours after treatment with the test substance. Symptoms like sedation, paddling movements, gait abnomality, piloerection, tremor, impaired coordination, loss of weight, squatting and abdominal position were protocolled. 24 and 48 hours after treatment most of the animals still showed the described serve clinical signs. 72 hours after treatment only one male still showed these severe clinical symptoms and one female was found dead. The other animals showed milder clinical signs. Piloerection and loss of weight were protocolled. Individual animals showed mild clinical signs until day 5. After day 5 until the end of the observation period there were no more signs of systemic reaction to treatment.

In the frist 4 days after application of the test substance, bodyweight loss was noticed in male and female animals. After day 5 until the end of the study, all animals achieved satisfactory bodyweight gains.

The macroscopic examination of the feals animal found dead 72 hours after application of the test substance showed emaciation, autolytic changes, lesions caused by cannibalism, hyperaemia of the gastric mucosa and the lung and lung emphysema.

The animals killed on day 14 showed thickening and induration of the mucosa of the forestomach. No other abnormalities were observed in these animals.

The dosis letalis media (LD50oral) to male and female rats of TRIMETHYLHEXANAL was found to be: > 2000 mg/kg