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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
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation, for read-across substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
-reliability scoring was based on 2001 guideline
Deviations:
yes
Remarks:
-insignificant deviation, guideline suggests using animals of all the same sex; no necropsy conducted
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Secondary Butyl Alcohol
- Physical state: colourless, clear liquid
- Analytical purity: 99.5%
- Expiration date of the lot/batch: one calendar month from the date of issue
- Lot/batch No.: Indent 9200/9530
- Stability under test conditions: Test substance was judged to have been stable for the duration of this study.
- Storage condition of test material: Following its arrival in compound control this test substance was stored in the dark at ambient temperature.

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Ltd.
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: Weight on Day 1 = 189 to 219 g (males) and 125 to 149 g (females)
- Fasting period before study: Fasted overnight (18 h) prior to dosing.
- Housing: Two days before dosing, the rats to be used were housed in groups of 2 or 3 animals of the same sex per cage.
- Diet (e.g. ad libitum): Food (PRD, Labsure Animal Foods, Dorset), ad libitum
- Water (e.g. ad libitum): Filtered but untreated water from the public supply, ad libitum
- Acclimation period: not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): air temperature was 19 to 25 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- 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: not reported

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Range finding studies were performed.
Doses:
950, 1200, 1500, 2000, and 2400 mg/kg
No. of animals per sex per dose:
5 rats/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed for clinical signs over 14 days. Body weight measurements were recorded on Days 1, 7, and 14.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight
Statistics:
Acute oral LD50 values were calculated using probit analysis (Finney, 1977).

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
2 054 other: mg/kg
Remarks on result:
other: 95% fiducial limits were 1283 - 4018 mg/kg
Sex:
female
Dose descriptor:
LD50
Effect level:
2 328 other: mg/kg
Remarks on result:
other: 95% fiducial limits were 1470 - 5428 mg/kg
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 193 other: mg/kg
Remarks on result:
other: 95% fiducial limits were 1608 - 4146 mg/kg
Mortality:
Over the 14-day observation period, 0, 1, 2, 1, and 8 animals died in the 950, 1200, 1500, 2000, and 2400 mg/kg dose groups, respectively. For more details, refer to Table 1 (attached).
Clinical signs:
All rats at all dose levels had gait and/or posture abnormalities. In the higher dose groups some rats were comatose or prostrate within a few hours of dosing, with some animals being unconscious for 24 hours or more. Some rats in the top dose group (2400 mg/kg) died within 3.5 h of dosing. All rats had either succumbed or recovered by day 3.
Body weight:
All surviving rats had gained weight relative to their day 1 body weights by the end of the 14 day observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met