1-(dimethylamino)propan-2-ol

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:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(dimethylamino)propan-2-ol

EC Number:

203-556-4

EC Name:

1-(dimethylamino)propan-2-ol

Cas Number:

108-16-7

Molecular formula:

C5H13NO

IUPAC Name:

1-(dimethylamino)propan-2-ol

Details on test material:

- Name of test material (as cited in study report): Dimethylamino-2-Propanol

Specific details on test material used for the study:

- Name of test material (as cited in study report): Dimethylamino-2-Propanol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc. Wilmington, Massachusetts
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 189-301 grams
- Housing: individually in stainless steel ½" wire mesh cages
- Diet: ad libitum, Harlan Teklad Lab Blox
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: at least 10% of body surface area was clear for application of test substance
- Type of wrap if used: porous gauze dressing (USP Type VII gauze), covered with dental dam, an elastical bandage and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: wrappings removed and residual test article removed with water and gauze
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: the test article was dosed as received using specific gravity calculations

Duration of exposure:

24 hours

Doses:

500, 1000, 2000 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: daily
- Frequency of weighing: at initiation, day 7 and day 14 or when found dead.
- Necropsy of survivors performed: yes
- Examinations performed: individual animal clinical signs, toxic signs, mortality, body weights

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 232 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 310 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died at 500 mg/kg bw, 5 of 10 animals died at 1000 mg/kg bw and 7 of 10 animals died at 2000 mg/kg bw.

Clinical signs:

other: 500 mg/kg bw 2 animals showed decreased activity and chromodacryorrhea along with erythema of the skin at the application site in 1 animal. Necrosis, sloughing and/or fissuring of the skin at the application site were observed in nearly all animals at thi

Gross pathology:

Necropsy of the animals that died on study revealed distended and/or fluid-filled intestines and stomach. Necrosis of the skin at the application site was noted in all animals. No other visible lesions were observed in any of the animals at terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

dermal LD50 = 1232 mg/kg bw