Reaction mass of (3R)-3-[(1R)-4-methyl-3-cyclohexen-1-yl]-1-butanol and (3S)-3-[(1R)-4-methyl-3-cyclohexen-1-yl]-1-butanol

Endpoint summary

Description of key information

Oral: LD50 = 2640 mg/kg bw, male/female rat, equiv. to OECD 401, Prince 1983

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-GLP but the method followed is similar to a recognised guideline. Limited test material characeterisation.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

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: not reported
- Age at study initiation: not reported
- Weight at study initiation: 100 - 250 g
- Fasting period before study: 24 hours
- Housing: stainless steel wire cages of USDA specifications
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25
- Humidity (%): 40 - 50
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

After the 24 hour fast period, the rats were weighed and dosed according to this weight by use of a blunt oral dosage needle and syringe (gavage).

Doses:

1,2,4 and 8 g/kg

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: daily
- Necropsy of survivors performed: no data

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 640 mg/kg bw

Based on:

test mat.

95% CL:

2 100 - 3 320

Mortality:

No test animals died in the 1 g/kg dose group. 2 animals died in the 2 g/kg dose group; 9 animals died in the 4 g/kg dose group and all test animals died in the 8 g/kg dose group.

Clinical signs:

other: not reported

Gross pathology:

not reported

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The acute oral median lethal dose (LD50) of the test material in male and female sprague dawley rats was estimated to be 2640 mg/kg body weight. The test material can be considered to be of low toxicity.

Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the sprague-dawley strain of rat. The study was performed pre-GLP and followed a method equivalent to OECD guideline 401. The test material was administered orally, after fasting for 24 hours, once only by gavage. 5 male and 5 female test animals were dosed at 1, 2, 4 and 8 g/kg body weight. Mortality and clinical signs were monitored during the study. No test animals died in the 1 g/kg dose group. 2 animals died in the 2 g/kg dose group; 9 animals died in the 4 g/kg dose group and all test animals died in the 8 g/kg dose group. The acute oral median lethal dose (LD50) of the test material in the male sprague-dawley strain rat was estimated to be 2640 mg/kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 640 mg/kg bw

Quality of whole database:

The available inforamtion as a whole meets the tonnage driven information requirements of REACH.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral:

The study was performed to assess the acute oral toxicity of the test material in the sprague-dawley strain of rat. The study was performed pre-GLP and followed a method equivalent to OECD guideline 401. The test material was administered orally, after fasting for 24 hours, once only by gavage. 5 male and 5 female test animals were dosed at 1, 2, 4 and 8 g/kg body weight. Mortality and clinical signs were monitored during the study. No test animals died in the 1 g/kg dose group. 2 animals died in the 2 g/kg dose group; 9 animals died in the 4 g/kg dose group and all test animals died in the 8 g/kg dose group. The acute oral median lethal dose (LD50) of the test material in the male sprague-dawley strain rat was estimated to be 2640 mg/kg bodyweight.

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for classification or non-classification

The substance does not meet classification criteria under EU Directive 67/548/EEC for acute toxicity.

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity.