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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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:
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 surviving animals in increased or decreased intensity, respectively, partly up to 3 days. Afterwards and during the entire observation period the animals appeared to be normal.
Body weight:
At the end of the observation period all surviving animals showed expected body weight gain.
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.