β,2,2,3-tetramethylcyclopent-3-ene-1-butanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 - 30 Jun 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No information on purity was given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

no data on purity of test substance; body weight was not determined weekly.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

β,2,2,3-tetramethylcyclopent-3-ene-1-butanol

EC Number:

276-333-2

EC Name:

β,2,2,3-tetramethylcyclopent-3-ene-1-butanol

Cas Number:

72089-08-8

Molecular formula:

C13H24O

IUPAC Name:

β,2,2,3-tetramethylcyclopent-3-ene-1-butanol

Test animals

Species:

rat

Strain:

other: BOR: WISW

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 156.9 - 210.0 g (males), 140.0 - 178.0 g (females)
- Fasting period before study: 16 h prior to and approx. 4 h after dosing
- Housing: in groups of maximum 5 animals in Macrolon cages (Typ III) on sawdust
- Diet: Ssniff-R Alleindiät für Ratten (Ssniff Versuchstierdiäten GmbH, Soest, Germany), ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 7.5 mL/kg bw

Doses:

Range-finding study: 2.5, 5.0 and 7.5 mL/kg bw
Main study: 2.5, 3.75, 5.0 and 7.5 mL/kg bw (corresponding to 2250, 3375, 4500 and 6750 mg/kg bw based on density of 0.9 g/cm³)

No. of animals per sex per dose:

Range-finding study: 2 females
Main study: 5 males and 5 females

Control animals:

no

Details on study design:

Range-finding study:
- Duration of observation period following administration: 14 days

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were recorded 15 and 45 min and 1.5, 3, 6, 24 and 48 h after administration and on Days 4 and 14. Individual body weights were determined on Days 0 and 14.
- Necropsy of survivors performed: yes

Statistics:

Probit Analysis according to Finney was used to calculate the oral LD50 values.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Remarks:

calculated using Probit Analysis acc. to Finney

Effect level:

5.24 mL/kg bw

Based on:

test mat.

Remarks on result:

other: (corresponding to 4716 mg/kg bw based on density of 0.9 g/cm³)

Mortality:

Range-finding study: All animals died at 5.0 and 7.5 mL/kg bw within 48 h after administration. No mortality occurred at 2.5 mL/kg bw.

Main study: At 2.5 mL/kg bw no mortality occurred during the study period. At 3.75 mL/kg bw one male and one female died within 24 and 48 h, respectively, after administration. At 5.0 mL/kg bw two males and one female died within 24 h and two females died within 48 h after administration. At 7.5 mL/kg bw four males and one female died within 24 h and 3 females died within 48 h after administration.

Clinical signs:

other: Disturbed awareness with apathy, abnormal body posture, disturbance of coordination, reduced reflex excitability, cyanosis, piloerection and reduced respiration rate were observed. The symptoms were observed 15 min after administration and lasted in survi

Gross pathology:

Gross pathological examination of dead animals revealed redness and partly liquid accumulation in the entire digestive system. No gross pathological findings were observed in rats sacrificed at study termination.

Any other information on results incl. tables

Table 1. Mortality.

Dose (mL/kg bw)	Males	Females
2.5	0/5	0/5
3.75	1/5	1/5
5.0	2/5	3/5
7.5	4/5	4/5

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study a LD50 value of 5.24 mL/kg bw (corresponding to 4716 mg/kg bw based on density of 0.9 g/cm³) was derived in male and female rats.