1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone

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:

1985

Report date:

1985

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:

1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone

EC Number:

239-360-0

EC Name:

1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone

Cas Number:

15323-35-0

Molecular formula:

C17H24O

IUPAC Name:

1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone

Test material form:

solid

Specific details on test material used for the study:

- Description: White waxy solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, the Netherlands
- Weight at study initiation: Males: 260-284g; Females: 154-184g
- Fasting period before study: In the overnight period before treatment till 4 hours after treatment
- Housing: Groups of 5 per sex in stainless steel cages with wire-screen bottom and front
- Diet: The Institute's cereal-based open formula diet for rats and mice, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 40-60
- Air changes (per hr): about 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: isopropyl myristate

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 17.5% (w/v)

DOSE VOLUME APPLIED: 4, 4.8, 5.76, 6.91, 8.29 mL/kg bw for the dose groups 700, 840, 1008, 1209, 1451 mg/kg bw, respectively

Doses:

700, 840, 1008, 1209, 1451 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed for signs of toxicity during the first 4 post-treatment hours and thereafter at least once daily. Individual body weights of the rats were recorded on day 0, 7, and 14.
- Necropsy of survivors performed: yes

Statistics:

LD50 was calculated according to the method of Weil, C.W. (Biometrics 8 (1952) 249-263)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

797 mg/kg bw

Based on:

test mat.

95% CL:

>= 703 - <= 905

Mortality:

700 mg/kg bw: Males 1/5; Females 2/5
840 mg/kg bw: Males 2/5; Females 5/5
1008 mg/kg bw: Males 2/5; Females 5/5
1209 mg/kg bw: Males 3/5; Females 5/5
1451 mg/kg bw: Males 4/5; Females 5/5
Deaths occurred between 18 hours and 9 days after dosing.

Clinical signs:

other: Within a few hours after dosing the rats showed sluggishness and piloerection. Later on, haematuria was observed until 2 days after treatment. After a few days, moreover, encrustations around eyes and nostrils, and signs of emaciation were observed. These

Gross pathology:

Macroscopic examination at autopsy of the rats that died on the first few post-treatment days revealed blood-stained urine in the bladder of all rats. In the rats that died thereafter and in those that survived the observation period no treatment-related gross alterations were found.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria