Reaction mass of 3,5-dimethylcyclohex-3-ene-1-carbaldehyde and 2,4-dimethylcyclohex-3-ene-1-carbaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparing to guidelines/standards, basic data is given.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: no data (see comments)

Principles of method if other than guideline:

In this acute oral toxicity study, no details test guideline was presented. However, it is indicated that 10 animals (unspecified sex) per dose and 4 dose levels: 1730 mg/kg, 2470 mg/kg, 3510 mg/kg, and 5000 mg/kg. The results provided were: mortality, time of death of individual animals at different dose levels, signs of toxicity at each dose, and necropsy findings at each dose.

GLP compliance:

not specified

Test type:

other: no data

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 3,5-dimethylcyclohex-3-ene-1-carbaldehyde and 2,4-dimethylcyclohex-3-ene-1-carbaldehyde

EC Number:

943-728-2

Molecular formula:

C9H14O

IUPAC Name:

Reaction mass of 3,5-dimethylcyclohex-3-ene-1-carbaldehyde and 2,4-dimethylcyclohex-3-ene-1-carbaldehyde

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Administration / exposure

Route of administration:

oral: unspecified

Doses:

1730 mg/kg, 2470 mg/kg, 3510 mg/kg, and 5000 mg/kg

No. of animals per sex per dose:

10 anmials per dose and unspecific sex

Control animals:

no

Details on study design:

- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 900 mg/kg bw

95% CL:

>= 2 900 - <= 5 100

Mortality:

At 1730 mg/kg: 3/10 deaths (2 animals by day 1 and 1 anmial by day 4);
At 2470 mg/kg: 1/10 deaths (by day 1);
At 3510 mg/kg: 3/10 deaths (2 animals by day 1 and 1 animal by day 2).
At 5000 mg/kg: 9/10 deaths (6 animals by day 1, 2 animals by day 2 and 1 animal by day 3)

Clinical signs:

other: At 1730 mg/kg: diarrhea, lethargy; At 2470 mg/kg: lethargy, piloerection, diarrhea, ptosis; At 3510 mg/kg: lethargy, diarrhea, piloerection, comatose; At 5000 mg/kg: lethargy, piloerection, chromorhinorrhea

Any other information on results incl. tables

Table 1: Necropsy observation

Doses (mg/kg)	1730	2470	3510	5000
Normal	6		4
Cannibalized			1
Exudate, nose/mouth, red	1		1
Exudate, nose/mouth, yellow				5
Exudate, nose/mouth, clear			1
Exudate, nose/mouth, brown		1	1	6
Intestines, areas red	2		2	10
Intestines, areas yellow	1	1	2	8
Intestines, bloated			1	9
Stomach bloated				1
Liver dark	3		3	6
Liver mottled		6	1	1
Lungs, areas dark	3		2	2
Lungs, dark				6
Lungs, fourescent red				1
Kidney dark	4	4	2	8
Kidney mottled		4	1
Spleen dark			2	5
Spleen large			2	3
Spleen mottled	1
Bladder, blood contained		1		3

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to CLP

Conclusions:

The acute median lethal oral doses (LD50) and their 95% confidence limits to rats of test substance was estimated to be:
LD 50: 3900 mg/kg bw (2900 - 5100 mg/kg bw; 95% C.I)

Executive summary:

In an acute oral toxicity study (1699 02/03), 40 rats (10 per group) were given single oral doses of Trigustral at 1730, 2470, 3510 and 5000 mg/kg bw and observed after dosing.

 

Oral LD 50: 3900 mg/kg bw (2900 - 5100 mg/kg bw; 95% C.I)

 

The following treatment-related effects were noted: clincal signs (lethargy, diarrhea with piloerection, chromorhinorrhea and ptosis noted with higher doses); mortality (at the lowest dosage, 3/10 animals dies; at the highest dosage, only one animal survived during 4 days observation period); necropsy observations (intestines, liver, lungs, kidney and spleen showed abnormalities that appeared dose related. The stomach and bladder showed sporadic abnormalities).