2-Cyclohexen-1-one, 3,4-dihydroxy-2,6,6-trimethyl-, sodium salt (1:1)

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:

other: GLP compliant guideline study, available as unpublished report. No restrictions, fully adequate for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Reference 2

Reference Type:

other: Amendment to the report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Acute Toxic Class Method (ATC Method) by E. Schlede, U. Mischke, R. Roll, D. Kayser: A National Validation Study of the Acute-Toxic-Class Method - An Alternative to the LD50 Test. Arch. Toxicol. 66: 455-470 (1992).

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1184842-87-2

Cas Number:

1184842-87-2

IUPAC Name:

1184842-87-2

Details on test material:

- Name of test material (as cited in study report): Asta-C9-Diol-Natrium
- Physical state/appearance: liquid, red-brown
- Storage conditions: Refrigerator, exclusion of light.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: DR. K. Thomae GMBH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 150g - 300g (+- 20 % of the mean weight).
- Fasting period before study: at least 16 hours
- Housing: Single housing in stainless steel wire mesh cages, type DK-III (Becker & co., Castrop-Rauxel, FRG). No bedding in the cages.
- Diet: Kliba-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, Switzerland, ad libitum.
- Water: Tap water ad libitum
- Acclimation period: At least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): Fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12 / 12 ( 6.00 a.m. - 6.00p.m. / 6.00 p.m. - 6.00 a.m.)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 gram per 100 mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Bodyweight determination: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period).
- Recording of signs and symptoms: Several times on the day of administration, at least once each workday for the individual animals
- General observation and mortality: Twice each workday and once on Saterdays, Sundays and on public holidays for general observations and for any dead or moribound animals.
- Necropsy of survivors performed: yes, at the last day of the observation period. Withdrawal of food at least 16 hours before killing withe CO2; then necropsy with gross pathology examination. Necropsy of all animals that died before as early as possible.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: Male animals: In all animals discoloured urine (orange) was observed on day 1 Female animals: All animals showed Impaired general state (H0 - H4), Dyspnoea (H0 - H4) and Piloerection (H1- H4). One animal showed signs of staggering (H0 - H3) and two animal

Gross pathology:

No pathologic findings noted

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

Under the conditions of this study the oral LD50 in male and female Wistar rats is above 2000 mg/kg bw.

Executive summary:

In a GLP compliant study performed according to EU method B.1, and modified according to the acute toxic class method, three Wister rats per sex were given a single oral dose of test material preparation in aqua bidest. at a dose level of 2000 mg/kg body weight. Signs of reaction to treatment noted in the female animals comprised impaired general state, dyspnea, staggering and twitching. In the male animals only orange discolored urine could be observed. The female animals appeared normal 1 day after application The expected body weight gain has been observed in the course of the study. No mortality occurred. No abnormalities were noted at necropsy of animals sacrificed at the end of the study (14 days). Under the conditions of this study the range of mortality after oral application was found to be greater than 2000 mg/kg body weight for male and female animals.