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Administrative data

Description of key information

Acute toxicity data indicate low toxicity: in rats the oral LD50 was 1360 mg/kg bw (comparable to OECD TG 402, non-GLP), and the dermal LD50 was 1232 mg/kg bw (according to OECD TG 402, GLP).

No adequate data for the assessment of acute inhalation toxicity are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimethyl-isopropanolamin
- Physical state: liquid
no further data
Species:
rat
Strain:
other: US-rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 148-314 g, females: 110-170 g
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2% or 20 % v/v

MAXIMUM DOSE VOLUME APPLIED:
16 ml/kg bw
Doses:
170, 680, 1360, 1700, 2125, 2720 mg/kg bw
No. of animals per sex per dose:
5-10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
no data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 360 mg/kg bw
Based on:
test mat.
Remarks on result:
other: ca. 1.6 ml/kg 20% (v/v)
Mortality:
0/10 animals died at 170 mg/kg bw
0/10 animals died at 680 mg/kg bw
10/20 animals died at 1360 mg/kg bw
10/20 animals died at 1700 mg/kg bw
6/10 animals died at 2125 mg/kg bw
9/10 animals died at 2720 mg/kg bw
deaths occured within day 1-3
Clinical signs:
On the day of administration: apathy, staggering, dyspnoea.
On the following days: calm behaviour, fluffy fur, crusted eyes.
The surviving aninmals were without findings within 4-6 days.
Body weight:
no data
Gross pathology:
haemorrhagic gastroenteritis in the dead animals, organs of the surviving animals without findings
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
oral LD50(rat) = ca. 1360 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 360 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimethylamino-2-Propanol
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
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
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.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
dermal LD50 = 1232 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 232 mg/kg bw

Additional information

Oral toxicity

In an acute oral toxicity study comparable to OECD guideline 401, US-rats (5-10/sex/dose) were administered dimethylisopropanolamine at 170 to 2720 mg/kg bw by single dose (gavage) followed by a 7-day observation period (BASF AG, 1964). Clinical findings included apathy, staggering, and dyspnoea at the day of administration, on the following days calm behaviour, fluffy fur and crusted eyes were observed. The surviving animals were without findings within 4-6 days. At pathology, haemorrhagic gastroenteritis was noted in animals that died during the test, the organs of the surviving animals were without findings. The LD50 was 1360 mg/kg bw.

 

Dermal toxicity

In an acute dermal toxicity test according to OECD guideline 402, 3 groups of rabbits (5/sex/dose) were treated with 500-2000 mg/kg bw dimethylisopropanolamine at a single intact skin site (clipped) for 24-hours and subsequently observed for a 14-day period (Pharmacon Research International, Inc., 1994). Decreased activity, chromodacryorrhea abnormal gait, abnormal stance, erythema, necrosis and brown nasal discharge were observed. Animals that died did not show clinical signs. The LD50 was 1232 mg/kg bw.

 

Inhalation toxicity

In an inhalation risk test (comparable to OECD guideline 403), groups of rats (3-6/sex/dose) were exposed to a saturated dimethyl-isopropanolamine atmposphere for 3, 10 or 30 minutes (BASF AG, 1964). Using the vapour pressure of 11.7 hPa at 20 °C and the molecular weight of 103.2 g/mol, a theoretical saturated vapour concentration of 49.6 mg/L can be calculated. During exposure animals showed serious escape reflex, severe irritation of the mucous membrane, dyspnoea, and blood incrusted noses. In the 30-minutes exposure group all animals died (6/6) during the test, in the 10-minute exposure group 1 of 12 animals died, no deaths were observed after 3 minutes exposure. Pathological examination of animals dying during the test revealed greyish-brown incrustation in the nasal area, animals sacrificed 7 days after exposure were without findings. With these results, the determination of an LC50 is not possible and the acute inhalation toxicity can not be assessed. No other adequate data for the assessment of acute inhalation toxicity are available.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result, the substance is classified for Acute Oral Tox. 4 (H302: Harmful if swallowed) and Acute Dermal Tox. 4 (H312: Harmful in contact with skin) under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480. No adequate data for the assessment of acute inhalation toxicity are available.

 

Furthermore, 1-(dimethylamino)propan-2-ol is included in Annex VI of Regulation (EC) No. 1272/2008 with the following legal classification:

  • Acute Oral Tox. 4 (H302: Harmful if swallowed).