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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:
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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 on the hindlimbs was observed on days 7 through 10 for one female. There were no other clinical findings. With the exception of desquamation noted for one rat, all animals appeared normal by day 4 or earlier and throughout the remainder of the study.
Body weight:
There were no remarkable changes or differences observed in body weights.
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.