Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Study period:
25 Aug - 08 Sep 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to standard methods

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:
Internal BASF-Test: comparable to standard methods
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
3,7-Dimethyloctadien-2,6-al-1
Purity: >= 95 %

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wiga
- Weight at study initiation: males 26 g, females 22 g

Administration / exposure

Route of administration:
intraperitoneal
Details on exposure:
Injection of 0.681 - 50 % emulsion in 0.5 % aqueous CMC-solution with 2-3 drops of Cremophor EL
Doses:
215, 147, 100 and 68.1 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Volume of application: 10 ml/kg bw
- Duration of observation period following administration: 14 days
- Frequency of observations: 15 and 30 min, 1, 2, 4, and 5 hours, 1, 4, 5, 6, 7, 8, 11, 12, 13 and 14 days
- Necropsy of survivors performed: yes
- Body weight: at the initiation of the study, at day 4, 7 and 14

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
147 - 215 mg/kg bw
Remarks on result:
other: mortality: 215 mg/kg: males 5/5, females 2/5; 147 mg/kg: 0/10
Mortality:
215 mg/kg bw; males: 5 out of 5 animals died during the study (1 animal at day 3, 4 animals at day 4); females: 2 out of 5 animals died during the study (both at day 4)
147, 100 and 68.1 mg/kg bw: no animal died during the study
Clinical signs:
215 and 147 mg/kg bw; The animals showed dyspnoe, apathy, tremor, spastic movement and poor general state during the first 24 hours after injection

100 and 68.1 mg/kg bw:
no symptoms detectable
Body weight:
Nothing abnormal detected
Gross pathology:
Dead animals: no findings;
Sacrificed animals: liver agglutination

Applicant's summary and conclusion

Conclusions:
After intraperitoneal application of citral (vehicle carboxymethyl cellulose) to mice, no mortalities were observed at a dose of 147 mg/kg, whereas 5/5 males and 2/5 females died at a dose of 215 mg/kg.
Executive summary:

After intraperitoneal application of citral (vehicle carboxymethyl cellulose) to NMRI mice (groups of 5 males and 5 females) at doses ranging from 68 to 215 mg/kg, no mortalities were observed at a dose of 147 mg/kg, whereas 5/5 males and 2/5 females died at a dose of 215 mg/kg.