Alcohols, C14-15

Acute Toxicity: oral

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

Test material information

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:

other: No signs of intoxication. 

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.