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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Internal BASF method was used which was in large part equivalent to OECD guideline 401
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbutan-1-ol
EC Number:
205-289-9
EC Name:
2-methylbutan-1-ol
Cas Number:
137-32-6
Molecular formula:
C5H12O
IUPAC Name:
2-methylbutan-1-ol
Details on test material:
- Name of test material (as cited in study report): 2-methylbutanol-1
- Physical state: liquid
- Analytical purity: ca. 99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean 220 g (males), 170 g (females)
- Fasting period before study: 15 - 20 hours
- Diet: Herilan MRH-Haltung; H Eggersmann KG; ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 14.7, 21.5, 31.6, 50%
- Amount of vehicle (if gavage): 10 ml/kg bw
Doses:
1470, 2150, 3160, 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily recording of signs and symptoms from the day of administration till the end of the observation period. Daily check (twice) for moribund and dead animals (once during the weekend).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology.
Statistics:
Chi-Square analysis

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 172 mg/kg bw
Based on:
test mat.
95% CL:
3 501 - 5 060
Mortality:
5000 mg/kg bw: 2/5 males within 1 h; 3/5 males within 1 d; 4/5 females within 1 h; 5/5 females within 1 d
3160 mg/kg bw: 1/5 females within 1 d
Clinical signs:
other: See table 1
Gross pathology:
Surviving animals: nothing abnormal detected; dead animals: acute congestive hyperemia in the heart and cardiodilatation.

Any other information on results incl. tables

Table 1: Clinical signs

Time of occurrence in minutes (min), hours (h) or days (d)

Dose level

5000 (mg/kg bw)

3160 (mg/kg bw)

2150 (mg/kg bw)

1470 (mg/kg bw)

Symptoms

Dyspnea – shallow respiration

15 min–3 d

15 min–5 h

15 min–5 h

15 min–1 h

Stertorous respiration

3-7 d

-

-

-

Apathy

15 min–6 d

15 min–5 h

15 min–5 h

15 min–1 h

Abnormal/lateral position

15 min–5 h

15 min–5 h

15 min–5 h

15 min–30 min

Staggering

15 min–3 d

15 min–5 h

15 min–5 h

15 min–1 h

Paresis/ Atonia

15 min–5 h

15 min–5 h

15 min–5 h

-

Pain/ Corneal reflex absent

15 min–1 h

15 min–5 h

15 min–5 h

-

Narcotic-like state

15 min–1 h

15 min–5 h

15 min–5 h

-

Piloerection/ Erythema

15 min–7 d

4 h–5 d

-

-

Poor general state

15 min–6 d

15 min–5 h

15 min–5 h

-

Table 2: Body weight

Mean body weight of survival animals (g); M: male; F: female

Dose level (mg/kg bw)

5000

3160

2150

1470

Time after treatment

M

F

M

F

M

F

M

F

0

260

170

200

180

200

180

200

180

2-3

248

-

228

199

235

199

213

199

7

273

-

254

213

266

213

259

211

13

303

-

287

217

297

224

272

221

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU