(R)-3,7-dimethyloct-6-enal

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

The test substance (Citronellal; CAS 106-23-0) represents the racemate of the registered substance (R)-3,7-dimethyloct-6-enal (CAS 2385-77-5).

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Citronellal

EC Number:

203-376-6

EC Name:

Citronellal

Cas Number:

106-23-0

Molecular formula:

C10H18O

IUPAC Name:

3,7-dimethyloct-6-enal

Details on test material:

- Name of test material (as cited in study report): citronellal (3,7-dimethyl-6-octenal)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HAGEMANN
- Weight at study initiation: 220 g (male); 170 g (female)
- Fasting period before study: 15 - 20 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: from 21.5 to 50 %
- Amount of vehicle (if gavage): 10 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

DOSAGE PREPARATION (if unusual): administered as a 30 % aqueous emulsion in carboxymethylcellulose containing 1-2 drops of CREMOPHOR EL

Doses:

2150; 2610; 3160; 3830; 5000 mg/kg bw

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 2-4, day7, day 13 (weighing); 1 h, 2 h, 4 h, 5 h, and then daily on working days till the end of the study (clinical observations)
- Necropsy of survivors performed: yes

Statistics:

Industrial hygiene orientating investigation (1980): FINNEY, D.J., Probitanalysis, Cambridge University Press, 3. Edition, 1971; all doses investigated used for calculation; test on homogeneity: CHI**2-value: 5.28 degree of freedom: 3; CHI**2 probability: 84.74 % homogeneity: acceptable confidence limit 95% (LD50 dose 2555 mg/kg bw) lower: 422 upper: 3307
Evaluation of data (1981): Interpolation of LD50 using the respective dosing groups leading to a mortality close to 50% (male LD50: two dosing groups; female LD50: one dosing group; male/female LD50: two dosing groups; based on original data from 1980).

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 423 mg/kg bw

Remarks on result:

other: interpolation from two dosing groups (1981)

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 555 mg/kg bw

Remarks on result:

other: including all dosing groups (1980)

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 2 150 mg/kg bw

Remarks on result:

other: including one dosing group (1981)

Effect levels 4

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2 872 mg/kg bw

Remarks on result:

other: interpolation from two dosing groups (1981)

Gross pathology:

deceased animals: heart: acute atrial dilatation, acute venous congestion; liver: yellow confluent peripheral liver lobes
survivors: thickened gastroesophageal vestibule tip; single adhesions of liver and gastroesophageal vestibule; no findings in 2610 and 2150 mg/kg dosing groups.

Any other information on results incl. tables

Table 1: Acute toxicity - mortality

dose (mg/kg)	5000		3830		3160		2610		2150
sex	m	f	m	f	m	f	m	f	m	f
number of animals	5	5	5	5	5	5	5	5	5	5
deceased animals within 1 hour	0	0	0	0	0	0	0	0	0	0
on day 1	3	4	1	4	3	3	2	3	0	2
on day 2	3	5	1	4	3	5	2	3	0	2
on day 7	3	5	1	5	3	5	2	5	0	2
on day 14	3	5	1	5	3	5	2	5	0	2
overall	3/5	5/5	1/5	5/5	3/5	5/5	2/5	5/5	0/5	2/5
mean body weight gain in 13 days (g)	82	-	72	-	71	-	71	-	94	35

Table 2: Acute toxicity - clinical symptoms

dose (mg/kg)	5000	3830	3160	2610	2150
dyspnoea	***	***	***	***	***
apathy	***	***	***	***	***
abnormal position	***	***	***	***	***
tumbling	***	***	***	***	***
atony	***	***
paresis hindlimb	***			***
pain reflex absence	***
cornea  reflex absence	***
anaesthesia-like state	***
tremor	***
convulsions	***
spasmic gait		***	***
fibrillar convulsions		***	***	***
clonic cramps	***
scrubby coat	***	***	***	***	***
erythema		***	***	***
exsiccosis	***	***		***	***
clotted eyes				***
stretching cramps		***
fascic convulsions		***	***	***	***
poor general condition	***	***	***	***	***