Propane-1,2,3-triyl 3,5,5-trimethylhexanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 - 18 June 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no constant volume at the different dose levels, partially shorter acclimatisation period than 5 days

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,5,5-trimethylhexanoic acid

EC Number:

221-975-0

EC Name:

3,5,5-trimethylhexanoic acid

Cas Number:

3302-10-1

Molecular formula:

C9H18O2

IUPAC Name:

3,5,5-trimethylhexanoic acid

Test animals

Species:

rat

Strain:

other: Bor:WISW (SPF TNO)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Weight at study initiation: 169.2 g (mean value)
- Fasting period before study: 16 h
- Housing: 1-5 animals per cage
- Diet: R10 Alleindiät für Ratten (Ssniff Spezialfutter, Soest, Germany), ad libitum
- Water: ad libitum
- Acclimation period: 4-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.754 mL/kg bw

Doses:

631, 794, 1000, 1250 and 1580 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and clinical signs up to 6 h post-dose and daily thereafter. Animals were weighed prior to treatment and 1, 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy

Statistics:

Group mean body weights were calculated. The LD50 value and 95% confidence interval were calculated according to Litchfield and Wilcoxon (J Pharmacol Exp Ther 96:99, 1949).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 160 mg/kg bw

Based on:

test mat.

Mortality:

631 and 794 mg/kg bw: No mortality occurred.
1000 mg/kg bw: 1/5 males and 2/5 females died within 24 h post-administration.
1250 mg/kg bw: 1/5 males and 5/5 females died within 24 h post-administration.
1580 mg/kg bw: 5/5 males and 5/5 females died within 31 h post-administration.

Clinical signs:

other: All animals showed clinical signs of toxicity. 15-30 min after dosage, animals showed ruffled fur, cowering, stagger, slight sedation and ataxia as well as prone position. Subsequently animals showed lacrimation, hypoactivity, diarrhoea, laboured breathin

Gross pathology:

Post mortem macroscopic examinations showed hyperaemia of stomach and intestinal mucosa, scattered discolouration of liver and kidneys and extensively filled urinary bladders. Further observations included hyperaemia of the mucosa of the urinary bladder in 1 animal, hyperaemia of the lung in 2 animals, hyperaemia of the pancreas in 4 animals, hyperaemia of the subcutis in 4 animals. Necroscopy of surviving animals at the end of the study revealed partially severe hyperaemia of the small intestinal mucosa.

Applicant's summary and conclusion

Interpretation of results:

other: Acute tox. oral 4, H302. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).