Tricyclodecanedimethanol

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:

other: Comparable to guideline study with acceptable restrictions; no data on purity of test substance, limited reporting

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Study is a pre-guideline study, but the method used is similar to OECD Guideline 401 (Acute Oral Toxicity).

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tricyclodecanedimethanol

EC Number:

248-096-5

EC Name:

Tricyclodecanedimethanol

Cas Number:

26896-48-0

Molecular formula:

C12H20O2

IUPAC Name:

[3-(hydroxymethyl)tricyclo[5.2.1.0²,⁶]decan-8-yl]methanol

Details on test material:

- Name of test material (as cited in study report): TCD-Alcohol DM
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rat

Strain:

other: SPF-Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: own breeding
- Age at study initiation: no data
- Weight at study initiation: 84 - 134 g (mean weigth 100 g)
- Fasting period before study: yes, 16 hrs
- Housing: plastic material cages with planing chips
- Diet (e.g. ad libitum): ALTROMIN 1234 from Altrogge, Lage, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no date
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Polyglycol 400

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10%
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: approx. 5 mL (calculated from concentration, dose, and weight of animals)

Doses:

1600, 2000, 2240, 2500, 4000 mg/kg bw

No. of animals per sex per dose:

10 (only females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly recording of body weigth
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

LD50 was determined using probit analysis according to LINDER and WEBER. Confidence limits were calculated according to CAVALLI-SFORZA (Methods of the Department of Applied Mathematics of Hoechst AG).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

2 250 mg/kg bw

Based on:

test mat.

95% CL:

2 132 - 2 374

Mortality:

1600 mg dose group 0/10 rats
2000 mg dose group 0/10 rats
2240 mg dose group 8/10 rats (7 animals died between 50 and 290 min; 1 animal within 2 days)
2500 mg dose group 7/10 rats (5 animals died within 20 min; 2 animals within 2 days)
4000 mg dose group 10/10 rats (9 animals died within 20 min; 1 animal at 130 min)

Clinical signs:

other: Signs of intoxication: Moribund animals showed disorders of balance, intermittently breathing and died in prone position.

Gross pathology:

No findings during macroscopic examination of surviving and dead animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 was 2250 mg/kg bw in female rats. No classifcation required according to EU legislation.

Executive summary:

The acute oral toxicity of octahydro-4,7-methano-1H-indenedimethanol (TCD-Alcohol DM) was determined in groups of 10 fasted, female SPF-Wistar rats receiving a 10% solution of the test material in polyglycol 400 by oral gavage at doses of 1600, 2000, 2240, 2500 and 4000 mg/kg bw. The observation period was 14 days.

The oral LD₅₀ (females) was determined to be 2250 mg/kg bw (95% C.I. 2132 - 2374 mg/kg bw) (Hollander/Hoechst AG, 1975a).

Octahydro-4,7-methano-1H-indenedimethanol is of LOW TOXICITY based on the LD₅₀ in female rats.

This acute toxicity study in the rat ist acceptable. It complies with the retracted OECD guideline 401.