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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guideline method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: BASF-test according to internal SOP
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Citral
EC Number:
226-394-6
EC Name:
Citral
Cas Number:
5392-40-5
IUPAC Name:
3,7-dimethylocta-2,6-dienal
Constituent 2
Chemical structure
Reference substance name:
(Z)-3,7-dimethylocta-2,6-dienal
EC Number:
203-379-2
EC Name:
(Z)-3,7-dimethylocta-2,6-dienal
Cas Number:
106-26-3
Molecular formula:
C10H16O
IUPAC Name:
3,7-dimethylocta-2,6-dienal
Details on test material:
3,7-Dimethyloctadien-2,6-al-1 (Citral)
Purity: >= 95 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gassner

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
0.5 % aqueous CMC preparation with 2-3 drops Cremophor EL as emulsifier

VOLUME APPLIED: 20 ml/kg (highest dose), 13.63 ml/kg (6810 mg/kg dose) and 10 ml/kg (three lowest doses)
Doses:
2150, 3160, 4640, 6810 and 10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations (clinical signs): < 15, 15 and 30 min, 1, 2, 4 and 5 h, further on daily
- Frequency of weighing: at the beginning of the experiment, on day 3 and 7 and at the end of the experiment
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 6 800 mg/kg bw
Mortality:
see Table 1
Clinical signs:
other: 10000 mg/kg bw: the animals showed salivation, apathy, staggering, abdominal and lateral position, atony, narcotic state and no pain reflex before death. 6810 mg/kg bw: some animals showed apathy (1 h), staggering (1 h-5 h), salivation (15 min - 1 h), ruf
Gross pathology:
Dead animals: acute dilatation of the atriums; acute, congestive hyperemia; liver: peripheral lobule marking; intestine: atonic; thorax: sporadic hydrothorax;
Sacrificed animals: forestomach thickened, sporadic boutons, agglutinations with spleen and peritoneum

Any other information on results incl. tables

Pretest:

Mortality: 2/2 animals at 10,000 mg/kg bw, 1/2 animals at 4640 mg/kg bw, 0/2 animals at 1000, 215 or 46.4 mg/kg bw

Table 1: Mortality in main study

 Dose (mg/kg bw) No. of animals              Mortality within
     1h 24 h  48 h   7 d  14 d
 10000     5M  0/5  4/5   5/5  5/5  5/5
 5F  0/5   4/5   5/5   5/5   5/5
 6810     5M   0/5   0/5   2/5   2/5   2/5
 5F   0/5   0/5   1/5   2/5   2/5
 4640     5M   0/5   0/5   0/5   0/5   0/5
 5F   0/5  0/5    0/5   0/5  0/5 
 3160     5M   0/5   0/5   0/5   0/5   0/5
 5F   0/5   0/5   0/5   0/5   0/5
 2150     5M   0/5   0/5   0/5   0/5   0/5
 5F   0/5   0/5   0/5   0/5   0/5

Table 2: Mean body weight (male/female in g)

 Dose (mg/kg bw)  0 d  3d  7d  14d
 10000 220/160 
 6810 200/150 209/158 160/170 218/189 
 4640 200/160  210/168   209/173 224/187 
3160  200/150  223/163  209/174  243/188 
 2150 170/150  205/170 227/145  211/188

Applicant's summary and conclusion