Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-enecarbaldehyde

EC Number:

915-617-9

Molecular formula:

C13H22O2

IUPAC Name:

Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-enecarbaldehyde

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Blue Spruce Farms, Altamont, New York
- Weight at study initiation: 180 - 280 g (after fasting)
- Fasting period before study: 18 hours
- Housing: individually in stainless steel 1/2 inch wire mesh cages
- Diet: Wayne Lab Blox, ad libitum
- Water: fresh tap water, fit for human consumption, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Rationale for the selection of the starting dose: based on the results of a dose-range finding study

Doses:

In the range-finding study: 0.5, 1.6 and 5 mL/kg bw.
In the main study: 4.0, 4.5, 5.0, 5.5 and 6.0 mL/kg bw.

No. of animals per sex per dose:

In the dose-range finding study: 2
In the main study: 5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days in the main study and 72 hours in the dose-range finding study.
- Frequency of observations and weighing: before the study (after fasting) and at day 14 in the main study and day 3 in the dose-range finding study.
- Necropsy of survivors performed: yes (in the main study).
- Other examinations performed: clinical signs, body weight.

Results and discussion

Preliminary study:

In the dose-range finding study, 1 of 4 rats died at 5 mL/kg bw. Clinical signs observed included decreased activity, flaccid body tone, ptosis, abnormal stance, hunched body position, red exudate around nasal area, chromodacryorrhea, pilorection and vasodilation.

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 971 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Calculated based on the relative density of 0.9941 and LD50 > 5 mL/kg bw.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 4 971 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Calculated based on the relative density of 0.9941 and LD50 of > 5 mL/kg bw.

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

> 3 976 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Calculated based on the relative density of 0.9941 and LD50 of > 4 mL/kg bw

Mortality:

In the main study:
- 3 of 10 rats died at 4.0 mL/kg bw (2 males, 1 female) and 4.5 mL/kg bw (3 females)
- 4 of 10 rats died at 5.0 mL/kg bw (1 male, 3 females and 5.5 mL/kg bw (1 male, 3 females)
- 5 of 10 rats died at 6 mL/kg bw (2 males, 3 females).

Clinical signs:

other: In the main study, signs observed included ptosis, prostration, decreased activity, flaccid body tone and abnormal stance.

Gross pathology:

Necropsy of the animals dying on study revealed distended, fluid-filled intestines and bladder, bright red lungs and blanched adrenals. Terminal necropsy of the remaining animals revealed no visible lesions at any dose level.

Applicant's summary and conclusion

Interpretation of results:

other: Not harmful

Remarks:

in accordance with EU CLP (EC no 1272/2008 and its amendments)

Conclusions:

In the acute oral toxicity study with rats, the LD50 was > 3976 mg/kg bw for female rats, > 4971 mg/kg bw/day for male rats and > 4971 mg/kg bw for both sexes combined.

Executive summary:

In this oral study, performed according to a protocol similar to OECD guideline 401 and in the absence of GLP conditions, LD50 values of >3976 mg/kg bw and >4971 mg/kg bw were obtained for female and male Sprague-Dawley rats, respectively. The combined LD50 value for both sexes was >4971 mg/kg bw. The observed clinical signs included ptosis, prostration, decreased activity, flaccid body tone and abnormal stance. Necropsy of the animals dying during the study revealed distended, fluid-filled intestines and bladder, bright red lungs and blanched adrenals. Terminal necropsy of the remaining animals revealed no visible lesions at any dose level.