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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C14-16
EC Number:
269-790-4
EC Name:
Alcohols, C14-16
Cas Number:
68333-80-2
IUPAC Name:
pentadecan-1-ol
Details on test material:
Tradename Isalchem 145 C14-16 alcohols Type A. Equivalent to Alcohols, C14-15-branched and linear (no CAS).

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Nossan, Correzzana, Milan, Italy
- Weight at study initiation: 200 g (+- 20g)
- Fasting period before study:
- Housing: transparent polycarbonate cages, 5 animals per cage
- Diet: pelleted complete diet
- Water: filtered tap water, ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1
- Humidity (%): 55 +/-15
- Air changes (per hr): min. 8
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
undiluted
Details on oral exposure:
Not reported.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5M+5F 
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality several times during day 1  after dosing and daily thereafter. Survivors were weighed at the end of  the observation period.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No animals died.
Clinical signs:
No signs of intoxication. 
Body weight:
No adverse effect on weight gain. 
Gross pathology:
Unremarkable.
Other findings:
POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The rat oral LD50 for Isalchem 145 was >5000 mg/kg. There were no clinical signs of intoxication and findings at gross autopsy were unremarkable.