Isopropylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

only one dose level tested

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isopropylamine

EC Number:

200-860-9

EC Name:

Isopropylamine

Cas Number:

75-31-0

Molecular formula:

C3H9N

IUPAC Name:

propan-2-amine

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Isopropylamine
- Physical state: liquid
- Analytical purity: 99.9 %
- Lot/batch No.: 561211
- Storage condition of test material: refrigerator

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. THOMAE GmbH, Biberach, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: Animals of comparable weight (200 - 300 g)
- Housing: singly in stainless stell wire mesh cages, Type DK-III
- Diet: KLIBA-Labordiaet 343, Klingenthalmuehle AG, Switzerland, ad libitum
- Water: water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: aqua bidest

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 cm2
- Type of wrap if used: Four layers of absorbent gauze


REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water
- Time after start of exposure: 24 h


TEST MATERIAL
- Concentration (if solution): 10 %

Duration of exposure:

24 h

Doses:

400 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Several times at the day of application and at least once daily therafter.
- Frequency of weighing: Shortly before application, weekly thereafter and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 400 mg/kg bw

Based on:

act. ingr.

Remarks:

(10% dilution in water because of corrosivity)

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

400 mg/kg bw

Based on:

act. ingr.

Remarks:

(10% dilution in water because of corrosivity)

Mortality:

No mortality occurred.

Clinical signs:

other: On the day of application the animals showed the following syptoms: dyspnoea, apathy, staggering, spastic gait, tremor, piloerection, exophthalmos and poor general state.

Gross pathology:

Sacrificed animals:
Organs: no pathologic findings noted.
Skin: full thickness necrosis (4 males/4 females), superficial necrosis (1 female), superficial crust formation (1 male)

Any other information on results incl. tables

The acute dermal LD50 of the test material was found to be greater than 400 mg/kg bw for the male und female animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the mean LD50 in male and female rats was > 400 mg/kg bw

Executive summary:

Acute dermal toxicity was investigate in male and female Wistar rats (5 animals per sex). Application of 400 mg/kg test item (applied as 10% dilution in water) for 24 hours under semi-occlusive conditions did not cause lethal effects. On the day of application animals showed dyspnoea, apathy, staggering, spastic gait, tremor, piloerection, exophthalmos and poor general state. The diluted test material caused full thickness necrosis in 4/4 females and 4/4 males.