1,1,3,3-tetramethylbutylamine

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1,3,3-tetramethylbutylamine

EC Number:

203-491-1

EC Name:

1,1,3,3-tetramethylbutylamine

Cas Number:

107-45-9

Molecular formula:

C8H19N

IUPAC Name:

2,4,4-trimethylpentan-2-amine

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPFCpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG, Borchen, Germany
- Age at study initiation: males 7-8 weeks, females 9-10 weeks
- Weight at study initiation: males 140-199 g, females 148-168 g
- Fasting period before study: 16 hours before treatment
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-22.5°C
- Humidity (%): 40-65%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 18.04.1989 To: 04.05.1989

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

peanut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100, 147 and 215 mg/mL
- Amount of vehicle (if gavage): 2.15 mL/kg bw
- Justification for choice of vehicle: test item practically insoluble in water

Doses:

215, 316 and 464 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: continuously for the first 4-6 hours after adminstration, thereafter once daily
- Frequency of weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross necropsy

Statistics:

females: probit analysis
males: graphic estimation

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

313 mg/kg bw

95% CL:

221 - 443

Remarks on result:

other: probit analysis

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

381 mg/kg bw

Remarks on result:

other: graphic estimation

Mortality:

Males: 0/5, 0/5, 5/5
Females: 0/5, 3/5, 5/5
Deaths occured 40 minutes to 4 hours after administration.

Clinical signs:

other: The most dominant signs of toxicity were clonic convulsions, mydriasis and piloerection. Hypokinesia, stilted gait, strenous respiration, reddened skin, cyanosis, sunken sides and vocalization were recorded, too. Additionally chromodacryorrhea, red nasal

Gross pathology:

Only deceased rats showed reddening and spotted red to dark red discoloration in the glandular stomach and the small intestine.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

In this acute oral toxicity study in the rat the test item showed an LD50 value of 313 mg/kg bw for females and 381 mg/kg bw for males. The test item is corrosive and findings are considered to be mainly due to corrosivity.