Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets basic scientific principles, sufficiently documented

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Citronellal (78/742)

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wiga
- Weight at study initiation: 22-28 g (male); 22-24 g (female)
- Fasting period before study: 15 -20 hours prior to application

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
200, 700 mg/kg
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations: 15 min, 30 min, 1 h, 2 h, 4 h, 5 h, d 1-9, d 12-15; weighing: before exposure, d 2-4, d 7, d 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Statistic test on significance performed (no further details given)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 700 mg/kg bw
Mortality:
700 mg/kg: male: (5/5) day 1; female: (5/5) day 1;
200 mg/kg: male: (0/5) day 15; female: (0/5) day 15
Clinical signs:
see Table 1
Body weight:
see Table 2
Gross pathology:
no intra-abdominal precipitations or adhesions; no further findings were reported

Any other information on results incl. tables

Table 1: Clinical signs

Dose (mg/kg)

700

200

dyspnoea

***

***

apathy

***

***

abnormal position

***

tumbling

***

***

atony

***

twitches

***

spasmic movement

***

Saltation convulsions

***

clonic cramps

***

erythema

***

exsicosis

***

overbalance

***

disturbance of equilibrium

***

paresis

***

poor general condition

***

***

Table 2: Mortality and body weight gain

Dose (mg/kg)

700*

200*

sex

male

female

male

female

number of animals

5

5

5

5

dead animals after 1 hour

1

1

0

0

1 day 

5

5

0

0

2 days

5

5

0

0

7 days

5

5

0

0

15 days

5

5

0

0

mean body weight gain (g)

-

-

7.2

4.8

* used for LD50 calculation

LD50 > 200 mg/kg (statistical significance: 1%)

LD50 < 700 mg/kg (statistical significance: 1%)

observation period 15 days (male and female animals)

Applicant's summary and conclusion