Dimethylcyclohex-3-ene-1-carbaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed in 1978.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study was performed predating current guidelines

Justification for type of information:

The information is used for read across to Vertoliff.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: read-across information from an analogue is used

Justification for type of information:

The full read-across document can be found in the Acute Endpoint Summary in text and in the attached file.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 900 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 900 - <= 5 100

Interpretation of results:

other: Not acute harmful

Remarks:

in accordance with EU CLP (EC No. 1272/2008 and its updates)

Conclusions:

The acute oral toxicity test showed an LD50 of 3900 mg/kg bw.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dimethylcyclohex-3-ene-1-carbaldehyde

EC Number:

268-264-1

EC Name:

2,4-dimethylcyclohex-3-ene-1-carbaldehyde

Cas Number:

68039-49-6

Molecular formula:

C9H14O

IUPAC Name:

2,4-dimethylcyclohex-3-ene-1-carbaldehyde

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

1.73, 2.47, 3.51 and 5.0 g/kg bw

No. of animals per sex per dose:

10 animals (sex unspecified) per dose group

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 900 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 900 - <= 5 100

Mortality:

3/10, 1/10, 3/10 and 9/10 animals died in the 4 day observation period after exposure to 1.73, 2.47, 3.51 and 5.0 g/kg, respectively.

Clinical signs:

other: - 1.73 g/kg: diarrhea, lethargy - 2.47 g/kg: lethargy, piloerection, diarrhea, ptosis - 3.51 g/kg: lethargy, diarrhea, piloerection, comatose - 5.0 g/kg: lethargy, piloerection, chromorhinorrhea

Gross pathology:

- 1.73 g/kg: Normal (6/10), exudate, nose/ mouth red (1/10), intestines, areas red (2/10), intestines, areas yellow (1/10), liver, dark (3/10), lungs, areas dark (3/10), kidney dark (4/10), spleen mottled (1/10).
- 2.47 g/kg: Exudate, anogenital, brown (1/10), intestines, areas yellow (1/10), liver mottled (6/10), kidney dark (4/10), kidney mottled (4/10), bladder, blood contained (1/10).
- 3.51 g/kg: Normal (4/10), cannibalized (1/10), exudate, nose/mouth, red (1/10), exudate nose/ mouth, clear (1/10), exudate, anogenital, brown (1/10), intestine, areas red (2/10), intestine, areas yellow (2/10), intestine, bloated (1/10), liver dark (3/10), liver mottled (1/10), lungs, areas dark (2/10), kidney dark (2/10), kidney mottled (1/10), spleen dark (2/10), spleen large (2/10).
- 5.0 g/kg: Exudate, nose/ mouth, yellow (5/10), Exudate, anogenital, brown (6/10), intestines, areas red (10/10), intestines, areas yellow (8/10), intestines, bloated (9/10), stomach bloated (1/10), liver dark (6/10), liver mottled (1/10), lungs, areas dark (2/10), lungs dark (6/10), lungs, fluorescent red (1/10), kidney dark (8/10), spleen dark (5/10), spleen large (3/10), bladder, blood contained (3/10).

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful

Remarks:

in accordance with EU CLP (EC No. 1272/2008 and its updates)

Conclusions:

The acute oral toxicity test showed an LD50 of 3900 mg/kg bw.

Executive summary:

A pre-guideline study, equivalent to OECD guideline 401, was performed to identify the acute oral toxicity of the test substance. In this study 10 rats (sex unspecified) were administered with 1.73, 2.47, 3.51 and 5.0 g/kg bw. 3/10, 1/10, 3/10 and 9/10 animals died in the 4 day observation period after exposure to 1.73, 2.47, 3.51 and 5.0 g/kg, respectively. Some additional toxic effects included lethargy, piloerection and comatose. At necropsy, the following organs were affected: nose/mouth (exudate red, yellow and clear), anogenital (exudate), intestines (red and yellow and bloated), liver (mottled and dark), lungs (dark lungs), kidney (dark kidneys) and spleen (dark and large). These dose-related effects were likely irritant effects because the substance becomes an acid when oxidized. Under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to be 3900 mg/ kg bw.