Dimethylcyclohex-3-ene-1-carbaldehyde

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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: dermal

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 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:

> 5 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

other: Not acute harmful

Remarks:

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

Conclusions:

The acute dermal toxicity test showed an LD50 > 5000 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 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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:

rabbit

Strain:

not specified

Sex:

not specified

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Duration of exposure:

Not specified

Doses:

5.0 g/kg bw

No. of animals per sex per dose:

10 animals (sex unspecified)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

2/10 animals died on the first day in the 14 day observation period after exposure to 5.0 g/kg bw test substance.

Clinical signs:

other: - Toxic signs: Anorexia, lessened mobility due to severe edema & eschar of exposure site, ptosis (droopiness of a body part) - Skin irritation: moderate redness (1/8), severe redness (7/8), moderate edema (4/8) and severe edema (4/8).

Gross pathology:

At necropsy, the following organs were affected and the following signs observed: yellow exudate in nose/ mouth (2/10), red areas in intestines (3/10), yellow areas in intestines (1/10), bloated intestines (1/10), intestines containing dark green substance (1/10), liver dark (5/10), liver mottled (1/10), liver white nodules (2/10), lungs with areas dark (2/10), kidney mottled (2/10), kidney pale (1/10), skin sloughing of exposure area (1/10), skin edema (8/10), skin redness (9/10), skin hard/ thick (6/10).

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 dermal toxicity test showed an LD50 > 5000 mg/kg bw.

Executive summary:

A pre-guideline study, equivalent to OECD guideline 402, was performed to identify the acute dermal toxicity of the test substance. In this study 10 rabbits (sex unspecified) were administered with 5000 mg/kg test substance on the skin. Two out of ten animals died in the 14 day observation period after exposure to the test substance. Some additional toxic effects included anorexia, lessened mobility due to severe edema & eschar of exposure site, ptosis (droopiness of a body part) and skin irritation: moderate redness (1/8), severe redness (7/8), moderate edema (4/8) and severe edema (4/8). At necropsy, the following organs were affected and the following signs observed: yellow exudate in nose/ mouth (2/10), red areas in intestines (3/10), yellow areas in intestines (1/10), bloated intestines (1/10), intestines containing dark green substance (1/10), liver dark (5/10), liver mottled (1/10), liver white nodules (2/10), lungs with areas dark (2/10), kidney mottled (2/10), kidney pale (1/10), skin sloughing of exposure area (1/10), skin edema (8/10), skin redness (9/10), skin hard/ thick (6/10). Under the conditions of the test, the acute dermal LD50 for the substance in rabbits was > 5000 mg/ kg bw. Based on these results, the test substance is not considered to be acute harmful.