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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
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Exxal 8 (isooctanol)
- Physical state: liquid, colorless
- Analytical purity: unknown
- Lot/batch No.: HDHE-F-00020

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: 9-11 weeks
- Weight at study initiation: Males (197-206 g) Females (162-190 g)
- Housing: 5 per cage
- Diet (e.g. ad libitum): Kilba 343 rat chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 1 week
- Fasting period before study: 12 - 18 hours

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- 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 per animal
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 females, 5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 4 times during day 1, and daily during days 2 - 15
Statistics:
No data analyzed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
0%
Clinical signs:
-Sedation, ventral body position, hunched posture, ruffled fur. All recovered within 6 days of administration.
Body weight:
No findings noted.
Gross pathology:
No findings noted.

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 of isooctanol is >2000 mg/kg.
Executive summary:

In this study, male and female rats were administered a single oral exposure of 2000 mg/kg isooctanol and monitored for signs of acute toxicity daily for 15 days. This dose did not produce any mortality or any other adverse clinical signs of toxicity. It is concluded that the LD50 is greater than 2000 mg/kg.