Alcohols, C7-9-iso-, C8-rich

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

Alcohols, C7-9-iso-, C8-rich

EC Number:

271-231-4

EC Name:

Alcohols, C7-9-iso-, C8-rich

Cas Number:

68526-83-0

Molecular formula:

CnH2n+1OH (n = 7 to 9)

IUPAC Name:

Branched alcohols, C7-9, C8 rich

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 or test system 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:

other: -Sedation, ventral body position, hunched posture, ruffled fur. All recovered within 6 days of administration.

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.