4-(cyclohex-1-en-1-yl)-3-methylbutan-1-ol

Endpoint summary

Description of key information

Oral LD50 is 1000 mg/kg bw

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

- Test substance storage In refrigerator (2-8°C) in the dark
- Description: Clear colourless liquid
- Expiry date: 19 March 2015

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 141-182 g
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Housing: Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
- 2000 mg/kg (2.16 mL/kg) body weight
- 300 mg/kg (0.324 mL/kg) body weight
- Dose volume calculated as dose level (g/kg) / specific gravity

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

- 2000 mg/kg: 3
- 300 mg/kg: 6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability: Twice daily; Body weights: Days 1 (pre-administration), 8 and 15 and at death (if found dead or sacrificed after Day 1); Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 000 mg/kg bw

Based on:

test mat.

Mortality:

At 2000 mg/kg, one animal was found dead and one animal was sacrificed for humane reasons on Day 2.
At 300 mg/kg, no mortality occurred.

Clinical signs:

other: At 2000 mg/kg, lethargy, hunched posture, uncoordinated movements and piloerection were noted for all animals on Days 1 and/or 2. Additionally, the animal sacrificed for humane reasons also showed lateral recumbency, laboured respiration and hypothermia o

Gross pathology:

At 2000 mg/kg, abnormalities of the kidneys (papilla: discolouration, reddish and/or pelvic dilation) and/or urinary bladder (reddish contents) were found in the animals that died (or sacrificed for humane reasons) during the study. Macroscopic examination of the surviving animal at termination did not reveal any abnormalities.
At 300 mg/kg, macroscopic examination at termination did not reveal any abnormalities.

Interpretation of results:

Category 4 based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 000 mg/kg bw

Quality of whole database:

One klimisch 1 study is available performed in accordance with OECD guideline and following GLP.

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

In an acute oral toxicity study performed in accordance with OECD guideline 423 and following GLP, the test substance was administered by oral gavage to three female Wistar rats at 2000 mg/kg body weight. In a stepwise procedure two additional groups of three females were dosed at 300 mg/kg body weight. The animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15). At 2000 mg/kg, one animal was found dead and one animal was sacrificed for humane reasons on Day 2. At 300 mg/kg, no mortality occurred. At 2000 mg/kg, lethargy, hunched posture, uncoordinated movements and piloerection were noted for all animals on Days 1 and/or 2. Additionally, the animal sacrificed for humane reasons showed lateral recumbency, laboured respiration and hypothermia on Day 2. At 300 mg/kg, hunched posture and piloerection were noted for all animals on Days 1 and/or 2. The body weight gain shown by the animals over the study period was considered to be normal. At 2000 mg/kg, abnormalities of the kidneys (papilla: discolouration, reddish and/or pelvic dilation) and/or urinary bladder (reddish contents) were found in the animals that died (or sacrificed for humane reasons) during the study. Macroscopic examination of the surviving animal at termination did not reveal any abnormalities. At 300 mg/kg, macroscopic examination at termination did not reveal any abnormalities. The oral LD50 value of the test substance in Wistar rats was established to be within the range of 300-2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 1000 mg/kg body weight.

Justification for classification or non-classification

The test substance has to be classified for acute oral toxicity as Acute Toxicity 4: H302: harmful if swallowed according to Regulation (EC) No 1272/2008.