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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: GLP compliant, non guideline study, limitations in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The methods described by Hagan served as a guide. (E.C. Hagan, "Acute Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), pp. 17-25
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethyloct-6-enenitrile
EC Number:
257-288-8
EC Name:
3,7-dimethyloct-6-enenitrile
Cas Number:
51566-62-2
Molecular formula:
C10H17N
IUPAC Name:
3,7-dimethyloct-6-enenitrile
Details on test material:
- Name of test material (as cited in study report): Citronellal Nitril, #04526, J79-261 (no further data)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: 200-266g
- Fasting period before study: 18 hours
- Housing: Galvanized cages with indirect bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least two days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
3150, 3960, 4460, 6300, 7940 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
The acute oral toxicity of the test material was evaluated in 6-8 week old Wistar strain albino rats weighing 200-266g. The rats were dosed singly in groups of six per dose level. Animals were observed for signs of toxicity and mortality at 1, 3, 6 and 24 hours following dosing. Observations were made at least once daily thereafter for a total of 14 days. All surviving animals were sacrificed at the end of day 14, weighed and gross necropsy was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 490 mg/kg bw
95% CL:
>= 3 740 - <= 5 390
Mortality:
- 3150 mg/kg bw: 1/3 males, 0/3 females died.
- 3960 mg/kg bw: 1/3 males; 1/3 females died.
- 4460 mg/kg bw: 3/3 males; 2/3 females died.
- 6300 mg/kg bw: 3/3 males; 2/3 females died.
- 7940 mg/kg bw: 2/3 males; 3/3 females died.
Clinical signs:
other: - 3150 mg/kg bw: Clinical signs were normal. One animal died btw. day 7-14. - 3960 mg/kg bw: One animal showed slight depression for 24 hours, but recovered within 2 days. One animal died within two days and one animal died within 5 days. - 4460 mg/kg bw:
Gross pathology:
- 3150 mg/kg bw: The one animal that died had fibrous tissue encasing heart and lungs. In the other animals no gross pathology changes were observed.
- 3960 mg/kg bw: One of the four surviving animals showed fibrous tissue encasing the heart and lungs. In one of two animals that died during the observation period the following observations were made: head partially cannibalized, pyloric mucosa severely reddened, stomach ruptured, all abdominal viscera adhered to body wall and covered with a thin layer of fibrous tissue.
- 4460 mg/kg bw: In one animal which died during the observation period, a extremely pale liver and ruptured intestines were observed. Two other animals which died during the observation period where partially cannibalized.
- 6300 mg/kg bw: In three animals moderate reddened pyloric mucosa was observed. In the animal who died within one hour after treatment, test article was found in the stomach.
- 7940 mg/kg bw: One animal was partially cannibalized. In the other animals no gross pathology changes were observed.

Applicant's summary and conclusion