2-methylbutan-1-ol

Acute Toxicity: oral

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

Test material information

Constituent 1

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