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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: dermal
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 dermal toxicity study, no details test guideline was presented. However, it is indicated that 10 animals (unspecified sex) were dosed in a limit test (5000 mg/kg). The results provided were: mortality, time of death of individual animals, signs of toxicity, necropsy findings.
GLP compliance:
not specified
Test type:
other: no data
Limit test:

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

Type of coverage:
not specified
5000 mg/kg
No. of animals per sex per dose:
10 animals 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:
> 5 000 mg/kg bw
At 5000 mg/kg dose: 2/10 deaths (by day 2)
Clinical signs:
other: At 5000 mg/kg dose: anorexia, lessened mobility due to severe edema & eschar of exposure site, ptosis - Animal 1 - days 6 through day 14. Emaciated - Animal - day 14.

Any other information on results incl. tables

Table 1: Necropsy observations

Doses (mg/kg) 5000
Exudate, nose/mouth, red
Exudate, nose/mouth, yellow 2
Exudate, nose/mouth, clear
Exudate, nose/mouth, brown
Intestines, areas red
Intestines, areas yellow 1
Intestines, bloated 1
Intestines, contained dark green substance 1
Stomach bloated
Liver dark 5
Liver mottled 1
Lungs, white nodules
Lungs, areas dark 2
Lungs, dark
Lungs, flourescent red
Kidney dark
Kidney mottled 2
Kidney pale 1
spleen dark
spleen large
spleen mottled
Skin, sloughing of exposure area 1
Skin edema 8
Skin redness
Skin, hard/thick
Bladder, blood contained

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to CLP
Migrated information Criteria used for interpretation of results: EU
The acute dermal median lethal dose (LD50) of Trigustral in rabbits was found to be greater than 5000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study (1699 02/03), 10 rabbits were given single dermal dose of Trigustral at 5000 mg/kg bw and observed up to 14 days after dosing.


Dermal LD 50: >5000 mg/kg bw


There were 2/10 deaths on day 1. Signs of toxicity noted in animal 1 from day 6 through day 14 were anorexia, lessened mobility due to severe edema & eschar of exposure site and ptosis; animal 1 was emaciated by day 14. The following observations were noted during necropsy of all animals: intestines, liver, lungs, kidney and spleen showed abnormalities that appeared dose related. The stomach and bladder showed sporadic abnormalities. Skin sloughing of the exposure area (1/10); skin oedema (7/8), skin redness (9/10) and skin hard/thickness (6/10) were also noted.