rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol

Endpoint summary

Description of key information

Acute oral toxicity: LD50 > 5000 mg/kg bw (OECD TG 401).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 June 1984 - 28 June 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been follo wed but not GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

other: Section 1500.3 - Federal Hazardoes Substances Act Regulations - 16 CFR

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA (USDA licensed animal dealer)
- Females (if applicable) nulliparous and non-pregnant: not indicated
- Age at study initiation: not indicated
- Weight at study initiation: average body weight of males: 261 g; average weight of females: 214 g
- Fasting period before study: yes, overnight
- Housing: stainless steel cages with elevated wire mesh flooring; 5 rats/cage by sex
- Diet: ad libitum, Wayne Lab-Blox
- Water: ad libitum tap water
- Acclimation period: yes, duration of acclimation period not specified

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 18.3 - 22.8
- Humidity (%): 45 - 55
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14 June 1984 To: 28 June 1984

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 g/kg bw

Doses:

One fixed dose: 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently on the day of dosage and twice per day thereafter (morning and afternoon)
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the study.

Clinical signs:

No abnormal behaviour or adverse clinical signs were observed. All animals appeared normal throughout the 14 day observation period.

Body weight:

Average bodyweights at the end of the 14 day observation period: 350 g for males; 244 g for females. All animals showed normal bodyweight gain during the study.

Gross pathology:

No gross abnormalities were noted for the animals necropsied at the conclusion of the study.

Interpretation of results:

other: Not acute harmful

Remarks:

According to EU CLP (EC No. 1272/2008 and its amendments).

Conclusions:

The acute oral toxicity test with the substance showed an LD50 of >5000 mg/kg bw.

Executive summary:

The acute oral toxicity of the substance was determined in a similar to OECDTG 401 study: 10 rats (5 males and 5 females) were administered with the substance at a dose level of 5000 mg/kg bw by oral gavage. No animal died during the study and all animals appeared normal throughout the 14 day observation period. Following necropsy, there were no gross abnormalities found in any of the animals. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral:

The acute oral toxicity of the substance was determined in a similar to OECDTG 401 study: 10 rats (5 males and 5 females) were administered with the substance at a dose level of 5000 mg/kg bw by oral gavage. No animal died during the study and all animals appeared normal throughout the 14 day observation period. Following necropsy, there were no gross abnormalities found in any of the animals. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.

Justification for classification or non-classification

The substance does not need to be classified for acute oral toxicity according to EU CLP (EC No. 1272/2008 and its amendments).