4-isopropylcyclohexanol

Endpoint summary

Description of key information

Acute Oral:

Based on the LD50 results from the Moreno study (4 rats died at 2560 mg/kg and 9 died at 5000 mg/kg) and the IFF study (3 rats died at 2000 mg/kg and 7 died at 3200 mg/kg), the LD50 is therefore greater than 2000 mg/kg but less than 3200 mg/kg. In the IFF study the LD50 was determined to be 2607 mg/kg.

Therefore the substance is classified Category 5 for oral toxicity under GHS guidance.

Acute Dermal:

No rabbits died at 5000 mg/kg. Therefore no classification is required under GH guidance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

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.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

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

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.

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.

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.

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.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

April, 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study meets the EC Standards (conducted equivalent to OECD 401). Non GLP. Deviations: lack of study design details in the report, no details on test material, no details on test animals and environmental conditions. Only a very short description is reported. However, dose, number of animals and observation period are critical points which are mentioned in the study. Thus the result is considered reliable with restrictions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(lack of study design details in the report, no details on test material, no details on test animals and environmental conditions

GLP compliance:

no

Remarks:

not present at the time of performance

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
No data

ENVIRONMENTAL CONDITIONS
No data

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

No data

Doses:

670, 1310, 2560 and 5000 mg/kg

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data

Statistics:

No data

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 560 mg/kg bw

Based on:

test mat.

Mortality:

Four animals died at the 2560 mg/kg dose level and nine animals died at the 5000 mg/kg dose level. All animals survived at the 670 and 1310 mg/kg dose levels.

Clinical signs:

At the 2560 dose level salivation was observed and at the dose level 5000 mg/kg salivation and lethargy was observed.

Body weight:

No data.

Gross pathology:

No data.

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study with rats, performed equivalent to OECD 401 guideline, an LD50 >2560 mg/kg bw was determined.

Executive summary:

P-isopropyl cyclohexanol was tested in an acute oral toxicity study with rats, performed equivalent to OECD 401 guideline. Four animals died at the 2560 mg/kg dose level and nine animals died at the 5000 mg/kg dose level. All animals survived at the 670 and 1310 mg/kg dose levels. At the 2560 dose level salivation was observed and at the dose level 5000 mg/kg salivation and lethargy was observed. Based on the results, an LD50 >2560 mg/kg bw was determined.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 607 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Study period:

April, 1975

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study meets the EC Standards (conducted equivalent to OECD 402). Non GLP. Deviations: lack of study design details in the report, no details on test material, no details on test animals and environmental conditions. Only a very short description is reported.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

(lack of study design details in the report, no details on test material, no details on test animals and environmental conditions

GLP compliance:

no

Remarks:

not present at the time of performance

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
No data

ENVIRONMENTAL CONDITIONS
No data

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

No data

Duration of exposure:

No data.

Doses:

5000 mg/kg

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

No data

Statistics:

No data

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

No abnormalities were observed.

Body weight:

No data.

Gross pathology:

No data.

Other findings:

Moderate redness was observed in five animals and marked redness was observed in the other 5 animals.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity study with rats, performed equivalent to OECD 402 guideline, an LD50 >5000 mg/kg bw was determined.

Executive summary:

P-isopropyl cyclohexanol was tested in an acute dermal toxicity study with rabbits, performed equivalent to OECD 402 guideline. No deaths occurred.

Moderate redness was observed in five animals and marked redness was observed in the other 5 animals.

Based on the results, an LD50 >5000 mg/kg bw was determined.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed