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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparing to guidelines/standards, basic data is given.

Data source

Reference Type:
other company data

Materials and methods

Test guideline
according to 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

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 3,5-dimethylcyclohex-3-ene-1-carbaldehyde and 2,4-dimethylcyclohex-3-ene-1-carbaldehyde
EC Number:
Molecular formula:
Reaction mass of 3,5-dimethylcyclohex-3-ene-1-carbaldehyde and 2,4-dimethylcyclohex-3-ene-1-carbaldehyde

Test animals

not specified
not specified

Administration / exposure

Route of administration:
oral: unspecified
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:
Details on study design:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
not specified
Dose descriptor:
Effect level:
3 900 mg/kg bw
95% CL:
>= 2 900 - <= 5 100
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    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   10 
Intestines, areas yellow
Intestines, bloated   1 9
Stomach bloated       1
Liver dark 3  
Liver mottled   6 1 1
Lungs, areas dark 3  
Lungs, dark       6
Lungs, fourescent red        1
Kidney dark  4  4
Kidney mottled    
Spleen dark    
Spleen large      2  3
Spleen mottled       
Bladder, blood contained    

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to CLP
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).