Reaction mass of α-3,3-trimethyl-(αS,1R)-cyclohexanemethanol and α-3,3-trimethyl-(αR,1S)-cyclohexanemethanol

Endpoint summary

Description of key information

An acute oral toxicity study (limit test) was performed according to OECD Guideline 423 and in compliance with GLP.

The oral LD50 for the test item is higher than 2000 mg/kg bw in female rats. Therefore the substance is not classified according to CLP Regulation (EC) No 1272/2008.

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:

04-19 February 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

13 September 2013

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier Labs, Le Genest-St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 187-195 g
- Fasting period before study: Food was removed on Day 1 and then redistributed 4 h after administration of the test item.
- Housing: Animals were housed by group of three in solid bottomed clear polycarbonate cages with stainless steel mesh lid.
- Diet: Foodstuff (SAFE, A04), ad libitum
- Water: Drinking water (tap water from public distribution system), ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: Approximately 13 changes/h
- Photoperiod: 12 h dark / 12 h light

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.21 mL/kg bw

DOSAGE PREPARATION:
- In the first and second step of the study, the test item was administered by gavage under a volume of 2.21 mL/kg bw (corresponding to 2000 mg/kg bw according to the density of 0.903) using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: Animals were observed for any behavioural or toxic effects at 30 minutes, 1, 3, 4, 24 and 48 h after administration of the item and continued during 14 days following the administration of test item.
Bodyweight: Animals were weighed on Days 0 (just before administering the test item), 2, 7 and 14.
- Necropsy of survivors performed: Yes; On Day 14, the animals were anesthetized with sodium pentobarbital and administration continued to fatal levels and macroscopic examination was performed.

Statistics:

None

Preliminary study:

Not Applicable

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

An absence or decrease in spontaneous activity (6/6), in muscle tone (3/6) and in righting reflex (2/6), bradypnea (1/6), staggering gait (5/6) and myosis (6/6) were noted during the first hours of the test. The animals recovered a normal behaviour at 24 h pot-dose.

Body weight:

The body weight evolution remained normal during the study, compared to the historical control group.

Gross pathology:

No macroscopic abnormalities were observed at necropsy.

Other findings:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 for α-3,3-trimethylcyclohexanemethanol multiconstituent is higher than 2000 mg/kg bw in female rats. Therefore it is not classified according to CLP Regulation (EC) No 1272/2008.

Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, groups (6 female rats/dose) of Sprague Dawley rats were given a single oral (gavage) dose of α-3,3-trimethylcyclohexanemethanol multiconstiuent at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No mortality and no clinical signs were observed. Body weight gain of the treated animals was not affected by the test item. No macroscopic abnormalities were observed at necropsy. In this study, the oral LD50 of the test item was considered to be higher than 2000 mg/kg bw in female rats.

Therefore, the oral LD50 for the test item is higher than 2000 mg/kg bw in female rats. Therefore the substance is not classified according to CLP Regulation (EC) No 1272/2008.

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Justification for classification or non-classification

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, groups (6 female rats/dose) of Sprague Dawley rats were given a single oral (gavage) dose of α-3,3-trimethylcyclohexanemethanol multiconstiuent at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No mortality and no clinical signs were observed. Body weight gain of the treated animals was not affected by the test item. No macroscopic abnormalities were observed at necropsy. In this study, the oral LD50 of the test item was considered to be higher than 2000 mg/kg bw in female rats.

Therefore, the oral LD50 for the test item is higher than 2000 mg/kg bw in female rats. Therefore the substance is not classified according to CLP Regulation (EC) No 1272/2008.