Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
After some preliminary observations, the test material was given undiluted, by gavage to groups of five males and five females, in one single dose of 10.0 ml per kg body weight.
After treatment the rats received stock diet and tap water as libitum.
They were observed for signs of intication during 14 day period, after which autopsies were carried out on the survivors.
GLP compliance:
not specified
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
Citronellyl 3-methylcrotonate
EC Number:
244-019-4
EC Name:
Citronellyl 3-methylcrotonate
Cas Number:
20770-40-5
Molecular formula:
C15H26O2
IUPAC Name:
3,7-dimethyloct-6-en-1-yl 3-methylbut-2-enoate
Constituent 2
Chemical structure
Reference substance name:
3,7-dimethyloctyl 3-methyl-2-butenoate
EC Number:
275-360-7
EC Name:
3,7-dimethyloctyl 3-methyl-2-butenoate
Cas Number:
71383-07-8
Molecular formula:
C15H28O2
IUPAC Name:
3,7-dimethyloctyl 3-methylbut-2-enoate
Constituent 3
Chemical structure
Reference substance name:
3,7-dimethyloct-7-en-1-yl 3-methylbut-2-enoate
Cas Number:
74499-48-2
Molecular formula:
C15H26O2
IUPAC Name:
3,7-dimethyloct-7-en-1-yl 3-methylbut-2-enoate
Test material form:
liquid
Specific details on test material used for the study:
A 50 ml sample of the test material was received from the principal in January 1978. It was a colourless liquid with a pugent odour, designated Sinodor 688 and coded M-76-193.

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Young adult albino rats (wistar-derived)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Young adult albino rats (Wistar-derived) from the Institue's colony were used. The body weights of males varied from 209 to 248g, those of females from 145 to 186g. The rats were housed in groups of five in screen-bottomed stainless steel cages, in a well-ventilated room, maintained at 23-25°C. Before dosing the rats were fasted overnight.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
After some preliminary observations, the test material was given undiluted, by gavage to groups of five males and five females, in one single dose of 10.0 ml per kg body weight.
Doses:
10.0 ml per kg body weight
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
After some preliminary observations, the test material was given undiluted, by gavage to groups of five males and five females, in one single dose of 10.0 ml per kg body weight. Due to the small quantity of the test material, no higher doses could be given. After treatment the rats received stock diet and tap water ad libitum. They were observed for signs of intoxication during a 14 day period, after which autopsies were carried out on the survivors.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths
Mortality:
No deaths occured
Clinical signs:
other: Within a few hours after dosing the rats showed signs of sluggishness and decreased activity. Later on the rats recovered and looked quite healthy during the remaining part of the observation period. Macroscopic examination of the survivors at autopsy r

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
From these results it appears that the oral LD50 of Sinodor exceeds 10 ml per kg body weight.
Executive summary:

Acute oral toxicity was determined with a method similar to OECD Guideline 401.

At a dose of 10 ml/kg body weight, no deaths occured and clinical signs a few hours after dosing were that the rats showed signs of sluggishness and decreased activity.

Later on the rats recovered and looked quite healthy during the remaining part of the observation period. Macroscopic examination of the survivors at autopsy revealed no treatment related gross alterations.

From these results it appears that the oral LD50 of Sinodor exceeds 10 ml per kg body weight, GHS criteria not met.