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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 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:

yes

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:

rabbit

Strain:

not specified

Sex:

not specified

Administration / exposure

Type of coverage:

not specified

Doses:

5000 mg/kg

No. of animals per sex per dose:

10 animals 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:

> 5 000 mg/kg bw

Mortality:

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
Normal
Cannibalized
Exudate, nose/mouth, red
Exudate, nose/mouth, yellow	2
Exudate, nose/mouth, clear
Exudate, nose/mouth, brown
Intestines, areas red	3
Intestines, areas yellow	1
Intestines, bloated	1
Intestines, contained dark green substance	1
Stomach bloated
Liver dark	5
Liver mottled	1
Lungs, white nodules	2
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	9
Skin, hard/thick	6
Bladder, blood contained

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to CLP

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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.