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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
September 12, 1983 - October 20, 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study meets the EC Standards (conducted equivalent to OECD 401) and performed according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

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

Constituent 1
Chemical structure
Reference substance name:
4-isopropylcyclohexanol
EC Number:
225-035-0
EC Name:
4-isopropylcyclohexanol
Cas Number:
4621-04-9
Molecular formula:
C9H18O
IUPAC Name:
4-(propan-2-yl)cyclohexan-1-ol
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River breeding labs, Wilmington, Massachusetts
- Age at study initiation: No data
- Weight at study initiation: 180 - 280 g (after fasting)
- Fasting period before study: 18 hours
- Housing: Rats were housed individually in stainless steel wire mesh cages
- Diet: Free access to Wayne Lab Blox
- Water: Free access to fresh tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.25% Methylcellulose
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg (2000, 3200 and 5000 mg/kg) and 4 mL/kg (4000 mg/kg)

Doses:
Dose range finding study: 500, 1600 and 5000 mg/kg
Main study:
2000 and 3200 mg/kg test substance in 0.25% Methylcellulose
4000 and 5000 mg/kg test substance as received
No. of animals per sex per dose:
Dose range finding study:
2 males and 2 females
Main study:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations (pharmacotoxic and CNS effects): immediately and 1, 4 and 24 hours after dosing
- Bodyweights: on day 14
- Necropsy of survivors performed: yes
Statistics:
Not applicable.

Results and discussion

Preliminary study:
Signs observed included abnormal gait, abnormal stance, piloerection, ptosis, decreased body tone, decreased activity, diarrhea, hypersensitivity, salivation, poor grooming and prostration. None of the animals died at 500 mg/kg, one of four died at 1600 mg/kg and three of four died at the 5000 mg/kg dose level.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 607 mg/kg bw
Based on:
test mat.
95% CL:
> 2 075 - < 3 277
Mortality:
Three of the rats died at 2000 mg/kg, seven died at 3200 and 4000 mg/kg and all animals died at 5000 mg/kg.
Clinical signs:
Signs observed included decreased activity, ataxia, diarrhea, salivation, lacrimation, ptosis, poor grooming, chromodacryorrhea, piloerection, decreased body tone, abnormal gait, abnormal stance, tremors, epistaxis, body drop, semi-prostration, prostration, dilated pupils and hypersensitivity.
Body weight:
All surviving animals showed a normal body weight increase.
Gross pathology:
Necropsy of the animals dying on study revealed hemorrhages, desquamation and ulceration of the stomach. The stomach, intestines and bladder were fluid-filled and distended. The thymus, liver and adrenals were discolored. Congested testes and mottled lungs were observed. Poor grooming and wet ventral pellage were also observed. Terminal necropsy revealed no test substance related lesions in the remaining animals.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
In an acute oral toxicity study with rats, performed equivalent to OECD 401 guideline and performed according to GLP principles, an LD50 of 2607 mg/kg bw was determined.
Executive summary:

The test substance 83 -219 -02 was tested in an acute oral toxicity study with rats, performed equivalent to OECD 401 guideline and performed according to GLP principles.

Three of the rats died at 2000 mg/kg, seven died at 3200 and 4000 mg/kg and all animals died at 5000 mg/kg. Signs observed included decreased activity, ataxia, diarrhea, salivation, lacrimation, ptosis, poor grooming, chromodacryorrhea, piloerection, decreased body tone, abnormal gait, abnormal stance, tremors, epistaxis, body drop, semi-prostration, prostration, dilated pupils and hypersensitivity. Necropsy of the animals dying on study revealed hemorrhages, desquamation and ulceration of the stomach. The stomach, intestines and bladder were fluid-filled and distended. The thymus, liver and adrenals were discolored. Congested testes and mottled lungs were observed. Poor grooming and wet ventral pellage were also observed. Terminal necropsy revealed no test substance related lesions in the remaining animals. Based on the results, an LD50 of 2607 mg/kg bw was determined.

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