Alcohols, C16-17-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:

1997/10/17-1998/03/02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C16-19-branched

EC Number:

297-790-4

EC Name:

Alcohols, C16-19-branched

Cas Number:

93762-74-4

IUPAC Name:

93762-74-4

Details on test material:

- Name of test material (as cited in study report): Detergent alcohol 23731-52. Equivalent to Alcohols, C16-17, monobranched, type 2

- Substance type:

- Physical state: Clear, colourless liquid.

- Analytical purity: Purity data are the responsibility of the sponsor.

-Storage conditions: stored under nitrogen in the original container at room temperature.

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Charles River Laboratories, Inc., Portage, MI.

- Age at study initiation: Young adults.

- Weight at study initiation: 212-288g

- Fasting period before study: 18-20 hours

- Housing: Individual suspended wire mesh cages.

- Diet: PMI Feeds, Inc. Certified Rodent LabDiet 5002, at ca. 150 g per day during the study

- Water: Reverse osmosis treated municipal water (ad libitum)

- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 71.6-72.2

- Humidity (%): 41.2-45.2

- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

other: gastric intubation

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.88 ml/kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5M, 5F

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The rats were observed at ca. 1, 3 and 4 hours post dose on study day 0 and twice daily (morning and afternoon) thereafter. Body weights were obtained and recorded on study days -1, 0 (initiation), 7 and 14 (termination).

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals.

Statistics:

No statistical analysis was carried out in the study.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

All animals survived to scheduled necropsy.

Clinical signs:

other: Wet and/or dried yellow, red and/or black material on the nose, hindlimbs, forelimbs, anogenital, urogenital, ventral trunk, dorsal rump and/or entire ventral surface area was noted for all rats. Five rats had soft stool and/or mucoid faeces. Desquamation

Gross pathology:

There were no gross necropsy findings for any examined tissues.

Other findings:

No other findings reported.

Any other information on results incl. tables

The LD50 of Development Detergent Alcohol 23731 -52 was found herein to be greater than 5000 mg/kg when administered orally via gastric intubation to fasted male and female albino rats.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A LD50 value of greater than 5000 mg/kg was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.