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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 420: GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Exxal 13
- Physical state: clear liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
- Age at study initiation: 8-9 weeks
- Weight at study initiation: male (209-240 g), female (171-182 g)
- Housing: individual
- Diet (e.g. ad libitum): Kliba 343, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week
- Fasting: 12-18 h


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2 ml at 2000 mg/kg
Doses:
2000 mg/ml
No. of animals per sex per dose:
10 (5 male, 5 female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 4 times during test day 1 and daily during days 2-15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
Statistics:
No data analyzed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All animals survived.
Clinical signs:
Slight sedation and diarrhea noted in males 3 hours after start of the experiment. All signs resolved within 24 hours.
Body weight:
No effects reported.
Gross pathology:
No effects reported.
Other findings:
No effects reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for isotridecanol is greater than 2000 mg/kg.
Executive summary:

In this study, male and female rats were administered a single oral exposure (2000 mg/kg) of isotridecanol to assess the acute oral toxicity.  Clinical evaluations were made at 1, 2, 3, 5, and 24 hours post exposure and daily thereafter for 14 days.  All animals survived the exposure and the only adverse clinical effects were slight sedation and diarrhea noted a few hours after exposure.  These effects were resolved within 24 hours.  It is concluded that the LD50 is greater than 2000 mg/kg.