Registration Dossier

Diss Factsheets

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: The study predates GLP, but is similar to OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methyl-6-methyleneoct-7-en-2-ol
EC Number:
208-843-8
EC Name:
2-methyl-6-methyleneoct-7-en-2-ol
Cas Number:
543-39-5
Molecular formula:
C10H18O
IUPAC Name:
2-methyl-6-methyleneoct-7-en-2-ol
Test material form:
other: clear liquid
Details on test material:
Compound no. 70-39
Recieved 4/11/72

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
The body weight ranged from 200 to 250 grams.

Administration / exposure

Route of administration:
oral: unspecified
Details on oral exposure:
The drug was admistrered as a concentrate.
Doses:
4.0, 5.0, 6.25, and 7.8 g/kg bw
No. of animals per sex per dose:
10/dose, male
Control animals:
no
Details on study design:
-Rats were fasted for a minimum of 16 hours prior to adminstration of the test material.
-Observations for mortality were made at 1 and 6 hours after dosing and daily thereafter for fourteen days.
-Gross necropsies were performed on all survivors.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
5.3 mg/kg bw
Based on:
test mat.
95% CL:
>= 4.5 - <= 6.1
Mortality:
Death occurred overnight following administration of the drug.
2 animal died in the group dosed with 4.0 g/kg bw; 4 animals died in the group dosed with 4.0 g/kg bw; 7 animals died in the group dosed with 6.25 g/kg bw and 10 animals died in the group dosed with 7.8 g/kg bw.
Clinical signs:
The rats experienced ataxia, loss of righting reflex, lethargy, and piloerection. The

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A LD50 of 5.3 mg/kg bw (95% CI = 4.5-6.1) was obtained in the acute oral toxicity study with rats.
Executive summary:

In an acute oral toxicity study with rats, similar to OECD TG 401 but without GLP, the LD50 was 5.3 mg/kg bw (95% CI - 4.5 - 6.1). Groups of 10 male albino rats, Wistar strain (age unspecified) were dosed with 4.0, 5.0, 6.25 and 7.8 g/kg bw and observed for 14 days. The numbers of animals that died were 2 at 4.0 g/kg bw, 4 at 5.0 g/kg bw, 7 at 6.25 g/kg bw, and 10 at 7.8 g/kg bw. Clinical findings included ataxia, piloerection, lethargy, and loss of righting reflex. Although Gross necropsies were performed on all suvivors findings were not reported.