Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 232 mg/kg bw
Based on:
test mat.
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:
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 this dose level. All animals were normal by Day 2.
1000 mg/kg bw
All surviving animals showed decreased activity, abnormal gait and abnormal stance with the majority exhibiting chromodacryorrhea and a few with tremors, ptosis and brown nasal discharge. Animals that died did not show clinical signs. All surviving animals were normal by Day 6.
2000 mg/kg bw
The majority of the surviving animals showed decreased activity, abnormal gait, abnormal stance, chromodacryorrhea, brown nasal discharge and flaccid body tone with only 1 animal exhibiting tremors. Necrosis of the skin at the application site was observed in all surviving animals. Animals that died did not show clinical signs. All surviving animals were normal by Day 6.
Body weight:
There was an increase in mean body weight in all surviving animals on day 7 and at termination.
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

Categories Display