Registration Dossier

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 423 mg/kg bw
Remarks on result:
other: interpolation from two dosing groups (1981)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 555 mg/kg bw
Remarks on result:
other: including all dosing groups (1980)
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 2 150 mg/kg bw
Remarks on result:
other: including one dosing group (1981)
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

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

5

5

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

***

***

***

***

***

Applicant's summary and conclusion