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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study period not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Pre-OECD, Pre-GLP study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

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

Test material

1
Chemical structure
Reference substance name:
Reaction mass of [(3,7-dimethyloct-6-en-1-yl)oxy]acetaldehyde and [(3,7-dimethyloctyl)oxy]acetaldehyde
EC Number:
913-400-3
Molecular formula:
C12H22O2
IUPAC Name:
Reaction mass of [(3,7-dimethyloct-6-en-1-yl)oxy]acetaldehyde and [(3,7-dimethyloctyl)oxy]acetaldehyde
Test material form:
liquid
Details on test material:
Storage condition of test material: PURGE HEADSPACE WITH NITROGEN, REFRIGERATE (35 - 46.5 F / 2 - 8 C)

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No details

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No details
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at least daily
- Necropsy of survivors performed: not mentioned in the report

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
2/10 animals died. Death was observed on day 5 and 12.
Clinical signs:
Lethargy was observed.

Applicant's summary and conclusion

Interpretation of results:
other: not classified: criteria not met
Remarks:
according to EU CLP Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
The acute oral toxicity test showed an LD50 of >5000 mg/kg bw.
Executive summary:

In an acute oral toxicity study performed similar to OECD 401 (pre-OECD, pre-GLP) 10 rats were administered the test substance orally at a dose level of 5000 mg/kg bw. During the 14 -day observation period 2/10 rats died. Mortality was observed at day 5 and 12. The clinical sign observed was lethargy. The acute oral LD50 for the test substance in rats was determined to be >5000 mg/kg bw.

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