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Diss Factsheets

Administrative data

Description of key information

- Acute oral toxicity (rat), LD50 = 500 mg/kg bw

- Acute inhalation toxicity (rat), LC50 = 4.499 mg/L air

- Acute dermal toxicity (rat), LD50 > 2000 mg/kg bw

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
Study period:
01 June - 07 June 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Specific details on test material used for the study:
- Lot/batch No.: K322/1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: adult animals
- Weight range at study initiation: 150 - 300 g
- Housing: single housing in stainless steel wire mesh cages, type DK-III ( Becker & Co., Castrop-Rauxel)
- Diet: Kliba-Labordiet, Klingenthalmuehle AG Kaiseraugst, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 1 week
- Fasting period before study: 16 h

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle:
1.) 200 mg/kg: 2g/100 mL
2.) 500 mg/kg: 5 g/100 mL
3.) 2000 mg/kg: 20 g/100 mL
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: corresponds to the physiological medium

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD:
According to the guideline OECD 423 adopted from 1996, 25, 200 or 2000 mg/kg bw can be selected as starting dose. Due to the physical and chemical characteristics of the substance and composition the mid dose was seen as the best choice. At first this value was tested on 3 male animals. In this experiment no mortality was observed. In the next step substance was tested with the same dosis on 3 female rats. Again, no mortality was observed. According to the guideline 2000 mg/kg bw was tested with 3 rats on male rats. Again 3 animals died. In the next step 500 mg/kg bw was tested with 3 male animals. Due to mortality in this group the same dose was applied at 3 animals of the other sex.
Doses:
200, 500, 2000 mg/kg bw
No. of animals per sex per dose:
200 mg/kg bw: 3/ sex (males and females)
500 mg/kg bw: 3/ sex (males and females)
2000 mg/kg bw: 3/ sex (males)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight determination individually before administration, weakly thereafter and at the end of the study; signs and symptoms were recorded individually several times at day of administration, at least once each workday for each animal; mortality was checked twice each workday and once on other days.
- Necropsy of survivors performed: yes (gross pathology)
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
500 mg/kg bw
Based on:
test mat.
Mortality:
200 mg/kg bw: no mortality was observed (0/3 male animals; 0/3 female animals).
500 mg/kg bw: 1/3 male animals and 2/3 female animals died.
2000 mg/kg bw: all 3 treated male animals died.
Clinical signs:
other: At 200 mg/kg bw: no symptoms were detected for male and female animals. At 500 mg/kg bw: all female animals showed impaired, poor general state, dyspnoea, abdominal position, staggering, tremor, twitching, clonic convulsions, salivation, and lacrimation.
Gross pathology:
Animals that were sacrificed showed no particular findings in organs.
Animals that died had following findings:
At 2000 mg/kg bw, all animals showed severe hemorrhage in forestomach, glandular stomach and small intestine; the stomach muscles showed severe erythema
At 500 mg/kg bw, one male that died showed watery contents in the small intestine; one of the 2 females that died showed dilation (slight to moderate) of the stomach and small intestine, with watery contents. The second female that died showed slight hyperemia of the glandular stomach and in the liver, numerous foci were seen, with a diameter up to 2 mm, beige in colour, mainly affecting the right lateral lobe, and caudate process.

Table 1: Mortality

Male animals

 

 

 

dose [mg/kg] bw

200

500

2000

No of animals

3

3

3

Immediately
 after application

0

0

1

after 1hr

0

0

3

after 1 day

0

1

 

after 14 days

0

1

 

overall mortality

0

2

3

 

 

 

 

Female animals

 

 

 

dose [mg/kg] bw

200

500

 

No of animals

3

3

 

Immediately
 after application

0

0

 

after 3 hrs

0

1

 

after 1 day

0

1

 

after 14 days

0

0

 

overall mortality

0

2

 

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
An acute oral toxicity study with rat according to the OECD TG 423 (1996) was conducted, and the test item was applied at following dose levels: 200, 500 and 2000 mg/kg bw. At low and medium dose 3 male and 3 female rats and at high dose 3 male animals were tested.
Mortality was observed at highest dose (all 3 males died) and at medium dose (1 of 3 males and 2 of 3 females died). Therefore, the LD50 for DPMA is 500 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
500 mg/kg bw
Quality of whole database:
GLP and Guideline conform study.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 Aug 2011 - 13 Dec 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Lot/batch No.: 000STD77L0
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain as cited in the study report: RccHan:WIST
- Source: Harlan Laboratories B.V., Horst, Netherlands
- Age at study initiation: males, 8 to 9 weeks; females, 10 to 11 weeks
- Mean group weight at study initiation:
- Males: group 1, 240 g; group 2, 273 g; group 3, 234 g
- Females: group 1, 182 g; group 2, 186 g; group 3, 188 g
- Housing: Makrolon cages type M III (floor area about 800 cm2) for single housing; Polysulfon cages (floor area about 2065 cm2) for group caging (up to 5 animals/cage) if the animals were free from clinical signs and findings.
- Diet: Kliba-Labordiet (Maus/Ratte Haltung “GLP”; Provimi Kliba SA, Kaiseraugst, Basel, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes: 15 per hour
- Photoperiod (hrs dark/hrs light): 12/12
Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose/head only
Vehicle:
clean air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE
- A central air conditioning system provided cold air of about 15°C, which was passed through an activated charcoal filter, adjusted to room temperature, and passed again through a second particle filter (H13 (HEPA) Camfil Farr, Germany). The air was compressed (oil-free compressor) by filtering through an inlet air strainer and introducing into the compressor. After passed through an second ultra filter, the compressed, 15 bar air was stored in a storage of 1500 or 5000 L. The compressed air was conducted to the labs via pipes, where the pressure was reduced to 6 bar; in the laboratory, it was then used to generate the inhalation atmospheres.

GENERATION OF TEST ITEM VAPOURS
For each test group the vapours were generated by supplying amounts of the unchanged test substance to a heated vaporizer (glasses with thermostat, 50 °C) by means of a piston metering pump. The vapours that developed were taken up by the supply air and passed into the exposure system.

INHALATION CHAMBER
Head-nose inhalation system INA 60 (glass-steel construction, BASF SE, volume V ≈ 90 L): the animals were restrained in glass tubes and their snouts projected into the inhalation system. The exhaust air was filtered and conducted into the exhaust air of the building. The exposure system was located inside an exhaust cabin in an air-conditioned laboratory. During each exposure, the following parameters were recorded four times at about 1-hour intervals: continuous measurement of compressed air flow supply, with adjustment; continuous measurement of exhaust air flow, with adjustment. The lower amounts of exhaust air, which were adjusted by means of a separate exhaust air system, achieved positive pressures inside the exposure systems. This ensured that the mixtures of test substance and air were not diluted with laboratory air in the breathing zones of the animals.

TEST ATMOSPHERE ANALYSIS
The nominal concentrations of the test item vapours were calculated from the amounts of test item dosed and the supply air flows.
For determination of the concentration of the test item in the inhalation atmosphere, the test atmosphere sample volumes were adjusted to achieve suitable amounts of the test item in the samples of the test groups in reference to the calibration of the analytical method. 2-Propanol was used as sorption solvent and was contained in 3 absorption vessels connected in series. The contents of the first 2 vessels were pooled and analyzed for each sample; the third vessel was used to control the effectiveness of the sorption for all samples of the atmosphere and was analyzed separately at the end of the sampling campaign. Sampling was done immediately adjacent to the animals' noses at a separate spare port.
Sampling flow was 1 L/minute and sampling frequency was 4 at hourly intervals.

OXYGEN, TEMPERATURE AND HUMIDITY MONITORING
Since the air change (at least 33 times/hour, calculated by dividing the supply air flows by the volume of the inhalation chamber) was judged to be sufficient to prevent oxygen depletion by the breathing of the animals, no monitoring of oxygen content was done. The temperature in the inhalation chambers was measured continuously. The humidity in the inhalation chambers was measured with a dielectric probe.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Analysis was done by gas chromatography (for details, see above)
Duration of exposure:
4 h
Concentrations:
measured: 0.479 (test group 1), 2.303 (test group 2) and 5.073 (test group 3) mg/L air
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
DURATION OF OBSERVATION PERIOD
14 days

FREQUENCY OF OBSERVATIONS FOR MORTALITY AND CLINICAL SYMPTOMS
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays. Detailed clinical observations were recorded for each animal separately several times during exposure and at least once daily on the pre-exposure day and during the observation period.

FREQUENCY OF WEIGHING
Individual body weights were recorded once during the acclimatization period, shortly before exposure (day 0) and at least on days 1, 3 and 7, and before the sacrifice of the animals at the end of the observation period.

NECROPSY
At the end of the observation period the surviving animals were sacrificed with CO2-inhalation and were subjected to gross pathological examination as well as the animal which died before.
Statistics:
The LC50 was calculated by Probit analysis (Finney DJ, "Probit Analysis" Cambridge University Press, 1971); for results of the type ”LC50 greater than”, ”LC50 approx.”, or ”LC50 smaller than”, the binomial test was used for statistical evaluation (Steel RGD and Torrie JH, Principles and procedures of statistics a biometrical approach. McGraw - Hill, 1984)
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
4.499 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality occurred at the tested concentrations of 0.479 and 2.303 mg/L air.
At 5.073 mg/L air, 4/5 males and 5/5 females died during and after exposure (day 0), resulting in 90% mortality at the highest concentration level tested in this study.
All females and 2/4 males died during exposure (1male within 3h, all others within 4h), the remaining 2 males died shortly after exposure (day 0).
Clinical signs:
other: Clinical signs of toxicity in animals exposed to 0.479 mg/L comprised piloerection and substance contaminated fur. These various findings were observed after exposure on study day 0. No clinical signs and findings were observed from study day 1 onwards.
Body weight:
The mean body weights of the animals exposed to 0.479 mg/L decreased during the first post exposure observations day and increased from study day 3 onward.
The mean body weights of the animals exposed to 2.303 mg/L decreased during the first post exposure observations day and increased from study day 3 onward.
In the 5.073 mg/L group, the body weight of the male animal surviving the exposure period decreased during the first post exposure observations day and increased from study day 3 onward.
Gross pathology:
In animals exposed to 0.479 mg/L, necropsy revealed no gross pathological abnormalities.
In animals exposed to 2.303 mg/L, necropsy revealed no gross pathological abnormalities.
In animals exposed to 5.073 mg/L, necropsy of those animals that died (4 males, 5 females) revealed edema of the lung in only one female; necropsy of the remaining animals as well as of the male survivor revealed no gross pathological abnormalities.

Analytical monitoring of temperature and humidity:

Test Group

Mean Temperature (°C)

Mean relative humidity (%)

Group 1, 0.479 mg/L

28.0 ± 0.9*

55.3 ± 5.0

Group 2, 2.303 mg/L

23.1 ± 0.2

54.1 ± 2.1

Group 3, 5.073 mg/L

23.8 ± 0.3

67.8 ± 0.4

*, The mean temperature above the range given in the guidelines resulted from the technical need to use high generation temperature to reach the desired concentrations.

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The test item was investigated for acute inhalation toxicity in a study conducted with Wistar rats according to the OECD TG 403 (2009). The study conduct followed GLP. Groups of five male and five female rats were head - nose exposed during 4 hours to following measured concentrations of the test item vapour: 0.479, 2.303 and 5.073 mg/L air. In fact, the animals were exposed to the inhalation atmosphere for 4 hours plus equilibration time of the inhalation systems (t99 minimum 4 min).
Whereas no mortality was observed at the 2 lowest tested concentrations of 0.479 and 2.303 mg/L air, 90% mortality (4/5 males, 5/5 females) was reached at the highest test concentration of 5.073 mg/L air during and shortly after exposure. Clinical signs were observed in all 3 groups, lasting for up to 1 day following exposure; these signs comprised e.g., piloerection, substance contaminated fur, accelerated respiration, labored and intermittent respiration, abdominal respiration, red encrusted nose. The mean body weights of the animals decreased during the first post exposure observations day and increased from study day 3 onward. Necropsy was inconspicuous, except for one died female showing lung edema.
The LC50 for male and female rats was estimated to be 4.5 mg/L air.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
4 500 mg/m³ air
Quality of whole database:
GLP and Guideline conform study.

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
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1984
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Lot/batch No.: K322/1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain as cited in study report: chbb: thom (SPF)
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: young adult animals
- Weight at study initiation: 200-300 g
- Housing: single housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiet (Provimi Kliba SA, Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark/hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm2
- % coverage: 10
- Type of wrap if used: semi-occlusive dressing consisting of four layers absorbent gauze and Fixomull stretch (adhesive fleece)
- Fur was clipped 24 hrs before study begin

REMOVAL OF TEST SUBSTANCE
- Washing: after removal of the dressing, the application site was rinsed with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Application volume: 2.78 mL/kg bw
- Density: 0.719 g/mL
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
DURATION OF OBSERVATION PERIOD
14 days

FREQUENCY OF OBSERVATIONS FOR MOTALITY AND CLINICAL SYMPTOMS
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays. Clinical symptoms were recorded several times on the day of administration and at least once per workday thereafter.

FREQUENCY OF WEIGHING
Individual body weights were recorded shortly before exposure (day 0), weekly thereafter, and finally before the sacrifice of the animals at the end of the observation period.

SKIN FINDINGS
Individual examination of skin was done between 3 to 60 minutes after removal of the dressing (i.e., day 1), weekly thereafter, and at the end of the observation period. The findings were scored according to the Draize scoring system (Draize, JH, Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States Austin,Texas, 1959).

NECROPSY
At the end of the observation period the surviving animals were sacrificed with CO2-inhalation and were subjected to gross pathological examination as well as the animal which died before.
Statistics:
The binomial test (Snedecor GW and Cochran WG, Statistical methods, 8th ed., Iowa State University Press/Ames, 1989) was used.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality occurred.
Clinical signs:
other: Neither clinical symptoms of toxicity nor local skin reactions could be evidenced.
Gross pathology:
At necropsy, gross pathology revealed no abnormalities.

Body weight data:

Animals

Individual body weights (g)

Sex

Number

Day 0

Day 7

 Day 13

Males

1

279

304

333

2

276

296

322

3

280

308

346

4

276

298

328

5

276

301

329

Females

1

229

219

226

2

229

241

248

3

230

225

250

4

227

224

241

5

234

234

240

 

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was tested for acute dermal toxicity in rats in a limit test conducted according to the OECD TG 402 (1987). The study conduct was GLP conform. The test item was applied at 2000 mg/kg bw onto the clipped skin of each of 5 male and 5 female animals, under semi-occlusive conditions for 24 hours.
Neither mortality nor clinical symptoms of toxicity were observed. No skin reactions were noticed. Body weights and body weight gain were as expected, and at necropsy, gross pathology revealed no abnormalities. Therefore the LD50 for acute dermal toxicity was > 2000 mg/kg bw for male and female rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP and Guideline conform study.

Additional information

N,N-Dimethylpropylamine (DMPA) was tested for acute oral toxicity by single gavage in Wistar rats of both sexes, according to the OECD TG 423 (2000), at following doses: 200, 500, 2000 mg/kg bw; the study conduct followed GLP.

Whereas the lowest and mid dose groups consisted of 3 animals per sex each, only 3 males were tested with the high dose. At 2000 mg/kg bw, all animals died. At the mid dose of 500 mg/kg bw, 1/3 males and 2/3 females, i.e., 50% of the treated animals, died. At the lowest tested dose of 200 mg/kg bw, no mortality occurred. Clinical symptoms were observed at 2000 and 500 mg/kg bw, but not at 200 mg/kg bw. At 2000 mg/kg bw twitching, salivation, impaired/poor general state, dyspnoea, gasping, piloerection, staggering, fibrillar contractions, tonic convulsions and discoloured urine were reported. At 500 mg/kg bw, impaired/poor general state, dyspnoea, abdominal position, staggering, tremor, twitching, clonic convulsions, salivation, lacrimation, piloerection and smeared fur were reported. Gross pathological examination of the animals treated with 2000 mg/kg bw that died revealed severe hemorrhage in forestomach, glandular stomach and small intestine, and severe erythema on the stomach muscles (all animals). At 500 mg/kg bw, one male that died showed watery contents in the small intestine; one of the 2 females that died showed dilation (slight to moderate) of the stomach and small intestine, with watery contents. The second female that died showed slight hyperemia of the glandular stomach and in the liver, numerous foci were seen, with a diameter up to 2 mm, beige in colour, mainly affecting the right lateral lobe, and caudate process. Animals that were sacrificed showed no particular findings in organs. Thus, for acute oral toxicity, the LD50 for DMPA is 500 mg/kg bw.

DMPA was investigated for acute inhalation toxicity in a study conducted with Wistar rats according to the OECD TG 403 (2012); the study conduct followed GLP. Groups of five male and five female rats were head-nose exposed during 4 hours to following measured concentrations of the test item vapour: 0.479, 2.303 and 5.073 mg/L air. In fact, the animals were exposed to the inhalation atmosphere for 4 hours plus equilibration time of the inhalation systems (t99 minimum 4 min).

Whereas no mortality was observed at the 2 lowest tested concentrations of 0.479 and 2.303 mg/L air, 90% mortality (4/5 males, 5/5 females) was reached at the highest test concentration of 5.073 mg/L air during (mostly between 3 and 4 hours) and shortly after exposure. Clinical signs were observed in all 3 groups, lasting for up to 1 day following exposure; these signs comprised e.g., piloerection, substance contaminated fur, accelerated respiration, labored and intermittent respiration, abdominal respiration, red encrusted nose. The mean body weights of the animals decreased during the first post exposure observations day and increased from study day 3 onward. Necropsy was inconspicuous, except for one died female showing lung edema. Thus, for acute inhalation toxicity, the LC50 was estimated to be 4.5 mg/L air.

For testing of acute dermal toxicity, DMPA was applied onto the skin of 5 male and 5 female Wistar rats under semi-occlusive conditions at a limit dose of 2000 mg/kg bw; the test was done according to the OECD TG 402 and followed GLP (2000).

No mortality was observed. No clinical symptoms of toxicity were observed. Changes in body weight and body weight gain were as expected, and gross pathology revealed no abnormalities. No local signs of skin irritation were seen. Consequently a LD50 for male and female rats > 2000 mg/kg bw was derived.

Data on the structurally related substance DMEA (CAS 598 -56 -1) show comparable results:

LD50, rat, oral = 594mg/kg (Cat. 4)

LC50, rat, inhalation = 2.3 - 15.4 mg/L (Cat. 3)

LD50, rat, dermal > 2000mg/kg (no mortality)

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The substance is considered to be classified as Cat. 4 for acute oral toxicity (H302) and as Cat. 3 (H331) for acute inhalative toxicity under Regulation (EC) No 1272/2008. The test substance is not considered to be classified for acute dermal toxicity under Regulation (EC) No 1272/2008.