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Administrative data

Description of key information

In an acute oral toxicity study with DPM 3-800LC with male and female rats, performed equivalent to OECD 401 guideline, an LD50 of 2600 mg/kg bw was calculated. 
In an acute inhalation toxicity study with male and female rats, performed equivalent to OECD 403 guideline, an LC50 > 0.1 mg/L air was determined. It is not clear whether the maximum attainable concentration has been tested.
In an acute dermal toxicity study with male and female rabbits, performed equivalent to OECD 402 guideline, an LD50 > 10200 mg/kg bw was determined.

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:
December 1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study meets the EC Standards (conducted equivalent to OECD 401). Non GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
limited study design details in the report, no details on environmental conditions: not expected to affect the outcome of the study
GLP compliance:
no
Remarks:
not present at the time of performance.
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Charles River strain (COBS)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc. , North Wilmington, Massachusetts
- Age at study initiation: no data
- Weight at study initiation: 150 to 198 g
- Fasting period before study: 16 hours
- Housing: Housed in stock cages. Following oral administration of the test material, the rats were housed individually in observation cages.
- Diet: free access to standard laboratory rat diet (Purina Rat Chow)
- Water: free access to water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
No data
Route of administration:
other: oral, using a hypodermic syringe equipped with a ballpointed intubating needle.
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Rats were intubated with previously calculated doses of the undiluted test material.
Doses:
1400, 2000, 3000 and 4600 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights: At day 0 and day 14. Mortalities and/or reactions observed were recorded during the observation period of 14 days.
- Necropsy of survivors performed: yes
Statistics:
LD50 calculated using the techniques of Weil, Thompson, and Thompson and Weil.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 600 mg/kg bw
Based on:
test mat.
Mortality:
1400 mg/kg: no mortality
2000 mg/kg: 3 animals died
3000 mg/kg: 6 animals died (3 males, 3 females)
4600 mg/kg: all animals were found dead
Clinical signs:
Hyperpnea, hypoactivity, ruffed fur, tremors, dyspnea, muscular weakness, clonic convulsions (intermittent) and emaciation (highest dose only) were observed during the observation period.
Body weight:
Normal (group 1400 and 2000 mg/kg bw)
Gross pathology:
No abnormalities were observed.
Interpretation of results:
other: not classified according to Regulation (EC) No 1272/2008
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study with DPM 3-800LC with male and female rats, performed equivalent to OECD 401 guideline, an LD50 of 2600 mg/kg bw was calculated.
Executive summary:

The test substance DPM 3 -800LC was tested in an acute oral toxicity study with male and female rats, performed equivalent to OECD 401 guideline. Deaths occured at the 2000, 3000 and 4600 mg/kg dose levels. Hyperpnea, hypoactivity, ruffed fur, tremors, dyspnea, muscular weakness, clonic convulsions (intermittent) and emaciation were observed during the observation period. No effect on body weight was observed.

Based on the results, an LD50 of 2600 mg/kg bodyweight was calculated.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 600 mg/kg bw
Quality of whole database:
The study has a klimisch code 2.

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:
December 1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study meets the EC Standards (conducted equivalent to OECD 403). Non GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
no details on environmental conditions, no analytical data on the maximum attainable concentration.
GLP compliance:
no
Remarks:
not present at the time of performance.
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: albino Charles River strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River
- Age at study initiation: no data
- Weight at study initiation: 200 g (average)
- Housing: individually in stock cages
- Diet: free access to standard laboratory diet (Purina Rat Chow)
- Water: free access to water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
No data
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
clean air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Vapor generator
- Exposure chamber volume: 70 L
- Method of holding animals in test chamber: Each animal was caged separately
- Source and rate of air: 4.0 L/min
- Temperature, humidity, pressure in air chamber: 26°C and the pressure was 29. 79 inches Hg

TEST ATMOSPHERE
- Brief description of analytical method used: no data
- Samples taken from breathing zone: no

Analytical verification of test atmosphere concentrations:
not specified
Remarks:
Average nominal vapor concentration was calculated by dividing the generator weight loss by the total volume of air used during the test.
Duration of exposure:
4 h
Concentrations:
0.1 mg/L (nominal), 99% of maximum vapor concentration was established.
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:
Body weights were determined prior to inhalation exposure and for each surviving animal at the end of the 14-day observation period.
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.1 mg/L air (nominal)
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
other: No data.
Body weight:
No adverse effects were observed (results not included).
Gross pathology:
No abnormalities were observed.
Interpretation of results:
other: not classified according to Regulation (EC) No 1272/2008
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute inhalation toxicity study with male and female rats, performed equivalent to OECD 403 guideline, an LC50 > 0.1 mg/L air was determined.
Executive summary:

The test substance DPM 3 -800LC was tested in an acute inhalation toxicity study with male and female rats, performed equivalent to OECD 403 guideline. Concentration of 0.1 mg/L (nominal), 99% of maximum vapor concentration was established. No deaths occurred. At gross pathology no abnormalities were observed.

Based on the results, an LC50 > 0.1 mg/L air was determined.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
100 mg/m³
Quality of whole database:
The study has a klimisch code 2.

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:
December 1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The study meets the EC Standards (conducted equivalent to OECD 402). Non GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
limited study design details in the report, no details on environmental conditions: not expected to affect the outcome of the study
GLP compliance:
no
Remarks:
not present at the time of performance.
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.3 to 3.0 kg
- Housing: Individually in hanging rabbit cages
- Diet: Free access to standard laboratory rabbit ration (Purina Rabbit Chow Checkers)
- Water: Free access to water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
no data
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
The backs of the rabbits were shaved free of hair with electric clippers. The shaved area on each animal constituted about 30 percent of the total body surface area. On the testing day, the rabbits received skin applications of the undiluted test material. After each application, the exposure site was covered by wrapping the trunk of the animal with an impervious plastic sheeting which was securely taped in place. This plastic wrap insured intimate contact of epidermis and test material. To further prevent oral ingestion of the test material, each animal was fitted with a light-weight flexible plastic collar which was worn throughout the observation period.

REMOVAL OF TEST SUBSTANCE
- Washing: no, all residual material was removed
Duration of exposure:
24 hours
Doses:
3000 and 10200 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights: At day 0 and day 14. Mortalities, local skin reactions and abnormal behaviour were recorded during the observation period of 14 days.
- Necropsy of survivors performed: no
Statistics:
LD50 calculated using the techniques of Weil, Thompson, and Thompson and Weil.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 200 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Pale red, definable erythema and slight edema were noted at the site of contact with the test material. These reactions subsided six days later, at which time dryness and desquamation were noted. The latter two reactions continued until the end of the observation period.
Body weight:
Normal.
Gross pathology:
Necropsy revealed hyperemia of lungs of animals in both groups and skin findings consistent with those previously described at clinical signs.
Interpretation of results:
other: not classified according to Regulation (EC) No 1272/2008
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity study with DPM 3-800LC with male and female rabbits, performed equivalent to OECD 402 guideline, an LD50 > 10200 mg/kg bw was determined.
Executive summary:

The test substance DPM 3 -800LC was tested in an acute dermal toxicity study with male and female rabbits, performed equivalent to OECD 401 guideline. No deaths occurred up to highest tested concentration of 10200 mg/kg bodyweight.

Pale red, definable erythema and slight edema were noted at the site of contact with the test material. These reactions subsided six days later, at which time dryness and desquamation were noted. The latter two reactions continued until the end of the observation period.

Necropsy revealed hyperemia of lungs of animals in both groups and skin findings consistent with those previously described at clinical signs. Based on the results, an LD50 > 10200 mg/kg bodyweight was determined.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 200 mg/kg bw
Quality of whole database:
The study has a klimisch code 2.

Additional information

Acute oral:

The test substance DPM 3 -800LC was tested in an acute oral toxicity study with male and female rats, performed equivalent to OECD 401 guideline. The dose levels were 1400, 2000, 3000 and 4600 mg/kg bw.

Deaths occured at the 2000, 3000 and 4600 mg/kg dose levels. Hyperpnea, hypoactivity, ruffed fur, tremors, dyspnea, muscular weakness, clonic convulsions (intermittent) and emaciation were observed during the observation period. No effect on body weight was observed.

Based on the results, an LD50 of 2600 mg/kg bodyweight was calculated.

Acute inhalation:

The test substance DPM 3 -800LC was tested in an acute inhalation toxicity study with male and female rats, performed equivalent to OECD 403 guideline. Concentration of 0.1 mg/L (nominal), 99% of maximum vapor concentration was established. No deaths occurred. At gross pathology no abnormalities were observed.

Based on the results, an LC50 > 0.1 mg/L air was determined.

Acute dermal:

The test substance DPM 3 -800LC was tested in an acute dermal toxicity study with male and female rabbits, performed equivalent to OECD 401 guideline. The dose levels were 3000 and 10200 mg/kg bw. No deaths occurred up to highest tested concentration of 10200 mg/kg bodyweight.

Pale red, definable erythema and slight edema were noted at the site of contact with the test material. These reactions subsided six days later, at which time dryness and desquamation were noted. The latter two reactions continued until the end of the observation period.

Necropsy revealed hyperemia of lungs of animals in both groups and skin findings consistent with those previously described at clinical signs. Based on the results, an LD50 > 10200 mg/kg bodyweight was determined.


Justification for selection of acute toxicity – oral endpoint
Reliable acute toxicity study in rat equivalent to OECD 401.

Justification for selection of acute toxicity – inhalation endpoint
Reliable acute toxicity study in rat equivalent to OECD 403.

Justification for selection of acute toxicity – dermal endpoint
Reliable acute toxicity study in rabbit equivalent to OECD 402.

Justification for classification or non-classification

Based on the available data, DPM 3 -800LC does not have to be classified for acute oral, acute dermal and acute inhalation toxicity according to Regulation (EC) No 1272/2008. For inhalation toxicity the conclusion is data lacking as there is insufficient information.