Allyl (cyclohexyloxy)acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 Apr - 02 May 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No information on purity was given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

No information on purity was given.

GLP compliance:

no

Remarks:

Basic documentation of quality assurance of experimental procedures and study report available, but not comparable to nowadays GLP provisions

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Allyl (cyclohexyloxy)acetate

EC Number:

272-657-3

EC Name:

Allyl (cyclohexyloxy)acetate

Cas Number:

68901-15-5

Molecular formula:

C11H18O3

IUPAC Name:

allyl (cyclohexyloxy)acetate

Test animals

Species:

rat

Strain:

Wistar

Remarks:

BOR: WISW (SPF TNO)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 199.4 - 247.0 g (males), 150.0 - 187.2 g (females)
- Fasting period before study: food was withdrawn 16 h prior to and approx. 4 h after dosing.
- Housing: in groups of maximum 5 in Makrolon cages (Typ III), sawdust was used as bedding material
- Diet: Ssniff-R Alleindiät für Ratten (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 50 - 85
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

A range-finding study was carried out to establish a dosing regimen for the main study.

VEHICLE
- Concentration in vehicle: 25%

MAXIMUM DOSE VOLUME APPLIED: approx. 4 mL/kg bw

Doses:

Range-finding study: 1.0 and 2.5 mL/kg bw (corresponding to 1020 and 2550 mg/kg bw based on density of 1.02 g/cm³); 500 and 750 mg/kg bw
Main study: 250, 500, 750 and 1000 mg/kg bw

No. of animals per sex per dose:

Range-finding study: 2 females
Main study: 5 males and 5 females

Control animals:

no

Details on study design:

Range-finding study:
- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed 20 min and 1, 2, 3, 6, 24 and 48 h after administration and subsequently once daily for 14 days.

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 20 min and 1, 2, 3, 6, 24 and 48 h after administration and subsequently once daily for 14 days. Individual body weights were determined on Days 0 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Probit Analysis according to Finney (1971) was used to calculate the orale LD50 values.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

620.42 mg/kg bw

Based on:

test mat.

Mortality:

Range-finding study: All animals died at approx. 1020 and 2550 mg/kg bw within 24 h after administration. No mortality occurred at 500 and 750 mg/kg bw.

Main study: At 250 mg/kg bw no mortality occurred during the study period. At 500 mg/kg bw three animals died within 3 days after administration. At 750 mg/kg bw five animals died within 6 days after administration. At 1000 mg/kg bw all animals died within 3 days after administration.

Clinical signs:

other: Main study: The test substance induced apathy, posture anomalies, ataxia, decreased excitability, piloerection, ptosis and dark red coloured urine. The symptoms occurred in surviving animals approx. 20 min post administration and continued with first incr

Gross pathology:

Gross pathological examination of dead animals revealed partially severe gastrointestinal haemorrhages and one urinary bladder filled with bloody urin.
Post mortem examination of rats surviving until scheduled sacrifice on Day 14 revealed no abnormalities.

Any other information on results incl. tables

Table 1. Results of the acute toxicity study.

Group	Dose level (mg/kg bw)	Mortality
		24 h		48 h		7 days		6/14 days
		m	f	m	f	m	f	m	f
I	250	0/5	0/5	0/5	0/5	0/5	0/5	0/5	0/5
II	500	0/5	0/5	0/5	1/5	1/5	2/5	1/5	2/5
III	750	0/5	3/5	0/5	3/5	1/5	3/5	1/5	4/5
IV	1000	2/5	4/5	3/5	5/5	5/5	5/5	5/5	5/5

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

In this acute oral toxicity study a LD50 value of 620.42 mg/kg bw in male and female rats was calculated according to the method of Finney.