Alcohols, C12-15-branched and linear

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:

1991

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:

1991

Report date:

1991

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, C12-16

EC Number:

272-490-6

EC Name:

Alcohols, C12-16

Cas Number:

68855-56-1

IUPAC Name:

tetradecan-1-ol

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nossan - Correzzana (Milano)
- Age at study initiation: young adults
- Weight at study initiation: 200 +/- 20
- Fasting period before study: overnight
- Housing: transparent polycarbonate cages, 5 animals/cage
- Diet: pelleted complete diet
- Water: tap water, ad libitum
- Acclimation period: 1 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:

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

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: A careful clinical examination is made at frequent intervals during the first day and then daily. Body weights were recorded at the end  of the observation period and compared to controls.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Cageside observation include changes in the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomous and central nervous system, and somatomotor activity and behaviour pattern.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

All animals survived to the end of the 14 day observation  period.

Clinical signs:

other: None observed. 

Gross pathology:

None reported.

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 Alchem 125 is >5000 mg/kg. This dose caused no adverse effects.