Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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:

Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde

EC Number:

916-807-4

Molecular formula:

C13H20O

IUPAC Name:

Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde

Test material form:

liquid

Specific details on test material used for the study:

- Description: Clear liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 - 300g
- Fasting period before study: 18 hours
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

1220, 2470, 5000, 10140 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations performed: mortality, toxicity, pharmacological effects, gross pathology
- Frequency of observations: daily

Statistics:

LD50 and 95% Confidence Limits were calculated by the method of Litchfield and Wilcoxon (J. Phar. & Exp. Therap. 96:99, 1949)

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

4 100 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 800 - <= 5 900

Mortality:

1220 mg/kg bw: No mortality
2470 mg/kg bw: 1/10 (One animal died on day 1)
5000 mg/kg bw: 7/10 (Four animals died on day 1; two animals died on day 2, and one animal died on day 7)
10140 mg/kg bw: 10/10 (Six animals died on day 1; three animals died on day 2, and one animal died on day 7)

Clinical signs:

other: 1220 mg/kg bw: diarrhea, lethargy, ptosis 2470 mg/kg bw: lethargy, diarrhea, flaccid tone 5000 mg/kg bw: diarrhea, lethargy, flaccid tone, ataxia, ptosis, piloerection, coma. 1/4 survivors on day 4 had hair loss on head and neck 10140 mg/kg bw: diarrhea,

Gross pathology:

1220 mg/kg bw: No abnormalities observed
2470 mg/kg bw: The animal who died had red exudate of the nose/mouth region, yellow exudate of the anogenital region, red areas in the intestines, dark liver, dark lungs, and dark kidney. Of the nine animals who were sacrificed after 14 days, in 6 animals, no abnormalities were observed and in 3 animals dark areas in the lung were observed.
5000 mg/kg bw: In the seven animals who died the following observations were made: Red exudate of the nose/mouth region (2/7), Red exudate of the nose/mouth region (4/7), Brown exudate of the anogenital region (7/7), Red areas in the intestines (6/7), Bloated intestines (5/7), Stomach, liver and intestines covered by white opaque substance (1/7), Mottled liver (2/7), Dark lungs (3/7), Dark areas in the lung (4/7), Dark kidney (3/7), and Mottled spleen (1/7). In the animals who were sacrificed after 14 days no abnormalities were observed.
10140 mg/kg bw: The following observation were made: Red exudate of the nose/mouth region (10/10), Yellow exudate of the anogenital region (10/10), Red areas in the intestines (2/10), Bloated intestines (1/10), Bloated stomach (1/10), Dark liver (4/10), Mottled liver (6/10), Dark areas in the lung (10/10), Dark kidney (10/10), Dark spleen (3/10), Small spleen (1/10)

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria