polymeric zinc propylenebis(dithiocarbamate);propineb (ISO)

Endpoint summary

Description of key information

Reliable acute toxicity studies via oral, dermal and inhalation route are available. The test substance is not acutely toxic after oral or dermal exposure. However, it is harmful if inhaled.

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:

2010/03/03 to 2010/06/04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EC) No. 440/2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

17th December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The acclimatization period was at least 5 days. The organisms were given tap water, ad libitum, and the weight at dosing was 323-363 g males and 201-226 g females.

The animals were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals of the same sex during the acclimation period and three rats of the same sex and group during the treatment period. Each cage contained autoclaved sawdust.

The environmental conditions for temperature was 22 ± 2°C, humidity (30 to 70%), air changes (per hr): Approximately 12 and photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: 12 to 31 March 2010

Route of administration:

oral: gavage

Vehicle:

other:

Remarks:

0.5% (w/v) Methylcellulose/0.4% (w/v) Tween 80 in purified water.

Details on oral exposure:

The test item was administered once, using a metal gavage tube fitted to a 5 mL plastic syringe (0.2 mL graduations). The quantity of the test item administered to each animal was adjusted according to the body weight recorded on the day of dosing.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5, 50, 300 or 2000 mg/kg body weight.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Three males and three females were used for each step. The dose-level to be used as the starting dose-level was selected from one of four fixed levels, 5, 50, 300 or 2000 mg/kg body weight. The dose-level have been selected in agreement with the Sponsor, based on the results of a previous non GLP study, in which the acute oral LD50 of the test item was higher than 2000 mg/kg.

Therefore, the test item was administered to 3 males and 3 females at the dose-level of 2000 mg/kg then in agreement with the Sponsor, the dose-level was carried out on 3 males and 3 females to confirm the results.

Statistics:

The data did not warrant statistical analysis.

Key result

Sex:

male/female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

The dose of 2000 mg/kg bw induced no mortality.

Clinical signs:

other: other: No clinical signs were observed.

Gross pathology:

No abnormalities were observed at gross necropsy.

Table one

Doses, mortality /clinical signs/ animals treated

Dose (mg/kg bw)	Toxicological results*		Occurrence of signs	Mortality (%)
2 000 (1^st)	Males 0/0/3	Females 0/0/3	-	0
2 000 (2^nd)	Males 0/0/3	Females 0/0/3	-	0

Interpretation of results:

GHS criteria not met

Conclusions:

The objective of this study was to evaluate the toxicity of the test item, Propineb, following a single oral administration in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The test item was administered by oral route (gavage) to 2 groups of six fasted Sprague-Dawley rats (three males and three females) at the dose-level of 2000 mg/kg under a dosage-volume of 10 mL/kg. The acute oral LD50 cut-off of propineb in the rat was found to be 5000 mg/kg bw, the oral LD50 of the test item Propineb was higher than 2000 mg/kg in rats.

Executive summary:

The objective of this study was to evaluate the toxicity of the test item, Propineb, following a single oral administration in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

 

The test item was administered by oral route (gavage) to 2 groups of six fasted Sprague-Dawley rats (three males and three females) at the dose-level of 2000 mg/kg under a dosage-volume of 10 mL/kg. The test item was prepared in 0.5% (w/v) Methylcellulose/0.4% (w/v) Tween 80 in purified water.

Mortality, clinical signs and body weight gain were checked for a period of up to 14 days following the single administration of the test item. On completion of the observation period, the animals were sacrificed then subjected to a macroscopic post-mortem examination. The interpretation of results was based on the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations).

Neither mortality nor clinical signs observed during the study. Lower body weight gain was noted during the first week in 1/3 females of the first assay and in 2/3 females of the confirmatory assay. The body weight gain of the other animals was not considered to be affected by treatment with the test item. At necropsy, no apparent abnormalities were observed in any animal.

 

Under the experimental conditions of this study, the oral LD50 of the test item, Propineb, was higher than 2000 mg/kg in rats. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), concerning the potential toxicity by oral route, the test item should not be classified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 1-2) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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:

1998/02/21 to 1998/03/11

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:

1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

traditional method

Limit test:

no

Species:

rat

Strain:

Wistar

Remarks:

Hsd Cpb:WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Acclimatization period: at least 5 days.
- Weight at dosing: At the study start the variation of individual weights did not exceed ±10 % of the mean for each sex.
- Age: 2 - 3 months old.
- Housing: singly in conventional Makrolon® Type II cages, Cages and water bottles were changed twice a week while unconsumed feed was changed once per week. The legal requirements for housing experimental animals (86/609 EEC) were followed.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: Approximately 40 to 60%
- Air changes (per hr): Approximately 10
- Photoperiod (hrs dark / hrs light): 12

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Remarks:

The test substance was aerosolized as dust without the use of any additional vehicle.

Mass median aerodynamic diameter (MMAD):

>= 1.97 - <= 3.32 µm

Geometric standard deviation (GSD):

>= 1.97 - <= 2.31

Remark on MMAD/GSD:

500 mg/kg bw: MMAD = 1.97 µm, GSD = 1.97
1000 mg/kg bw: MMAD = 2.40 µm, GSD = 2.31
2500 mg/kg bw: MMAD = 3.32 µm, GSD = 2.15

Details on inhalation exposure:

For powder dispersion, conditioned compressed air (28 L of air/min; continuous operation) was used. The principle performance of the last dust generating system can be described as follows: The test substance was entrained into a glass reservoir (approximately 1/2 kg). From this reservoir it was fed (by suction) into the orifice of a venturi tube.

The airborne powder was then entrained into the inner cylinder of the inhalation chamber. Reproducible and temporally stable dosing into the orifice was achieved by an oscillating orifice. The orifice size was adjusted manually in order to obtain the targeted flow of powder. Stirring of the reservoir was performed using a minimum number of revolutions per unit of time. Thus the flowability of the test compound was maintained without inducing a vertical inhomogeneity of active ingredient and/or inert particles.

Optimization of respirability: The cyclone increases the efficiency of the generation of respirable particles and prevents larger particles from entering the chamber. To achieve the targeted high concentrations (group 3 and 4) the cyclone had to be omitted. Inhalation Chamber: The aluminum inhalation chamber has the following dimensions: inner diameter = 14 cm, outer diameter = 35 cm (two-chamber system), height = 25 cm (internal volume = about 3.8 L)

Airflows: During the exposure period air flows were monitored continuously and, if necessary, readjusted to the conditions required. Air flows were measured with calibrated flow-meters and/or soap bubble meter (Gilibrator, Strohlein Instruments, Kaarst) and were checked for correct performance at regular intervals.

Conditioning the compressed air: Compressed air was supplied by Boge compressors and was conditioned (i.e. freed from water, dust, and oil) automatically by a VIA compressed air dryer. Adequate control devices were employed to control supply pressure. Samples were taken from the breathing zone

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

470, 1043, 2420 mg/m³

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Duration of observation period following administration was 3 weeks. Observations and weighing for body weights were measured before exposure, on days 3 and 7, and weekly thereafter. Individual weights are also recorded at death, if applicable. The appearance and behavior of each rat were examined carefully several times on the day of exposure and at least once daily thereafter. Necropsy was performed of the survivors as well as rectal temperature

Statistics:

- Statistically significant differences (versus control) were indicated by asterisks ('*' for p < 0.05 and '**' for p < 0.01).

- Necropsy findings: pairwise Fisher test was used after the R x C chi-square test (HP 3000, Department of Toxicology, Bayer AG).

- Body weights and physiological data: one-way ANOVA (vide infra).

- Calculation of the LC50 performed by computer (HP 3000).If only 2 pairs of values with greater than 0% lethality and less than 100% are available then the first linear approximation is based on these values and a x2-homogeneity test is not performed. The interpolated concentration at 50% lethality in this case was
designated the approximate.

- Randomization: A computerized list of random numbers served the purpose to
assign animals at random to the treatment groups.

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

> 2 420 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Key result

Sex:

female

Dose descriptor:

LC50

Effect level:

983 mg/m³ air

Based on:

test mat.

95% CL:

>= 658 - <= 1 468

Exp. duration:

4 h

Mortality:

1043 mg/m³: 1/5 male rats died on day 7 and 3/5 female rats died between day 5 and 7 post exposure;
2420 mg/m³: 1/5 male rats died on day 8 and all female rats died between days 4 and 8 post exposure.
No mortality was observed in the low dose groups.

Clinical signs:

other: Exposure to 1043 and 2420 mg/m³ resulted in bradypnea, labored breathing pattern, dyspnea, motility reduced, limp, flaccid hindlimbs, prostration, emaciation, chromodakryorrhea, decreased body weights, hypothermia.

Body weight:

Decrease in body weights.

Gross pathology:

Animals that died intercurrently:
- Lungs: less collapsed, dark-red foci/areas;
- Intestine: red slimy content, red mucosa;
- Eyes: red encrustations; periorbital wetness;
- Hindlimbs: atrophy of musculature; thymus: dark-red foci.
Animals sacrificed at the end of the observation period: In rats exposed to the test compound a conclusive, concentration-dependent increased incidence of macroscopic findings could not be ascertained. Therefore, the gray/white-foci or discolorations of lungs observed, however, are not considered to be causally related to the exposure to the test substance. Findings such as mild discoloration's of lung and other parenchymatous organs are often observed in control animals euthanized with pentobarbital.

Other findings:

NOAEL:
Males & females: < 470 mg/m3 air

All male animals showed normal reflexes. One female rat in each of group 2 and 3 and 3 female rats of group 4 experienced a decreased tonus.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

A study on the acute inhalation toxicity with the test substance on rats has been conducted in accordance with OECD Guideline 403 and the respective EU-Guideline using propineb as a test substance. Groups of rats were nose-only exposed to average solid aerosol (dust) concentrations of 470, 1043 and 2420 mg/m³ air. The aerosolized test substance (dust) proved to have a low to moderate acute inhalation toxicity to rats. Specific pathognomonic findings indicating a causal relationship between exposure concentration and mortality cannot be deduced from the findings obtained.

Executive summary:

A study on the acute inhalation toxicity with the test substance on rats has been conducted in accordance with OECD Guideline 403. Groups of rats were nose-only exposed to average solid aerosol (dust) concentrations of 470, 1043 and 2420 mg/m³ air. 

 

Exposure to a dust concentration of 470 mg/m³ was tolerated without mortality and rats merely showed transient and minimal clinical signs, such as limp appearance, decrease in body weights and hypothermia. Exposure to 1043 and 2420 mg/m³ resulted in delayed type mortality between the forth or eighth postexposure day.

 

In these exposure group signs were observed up to postexposure day 15 (major signs included: Bradypnea, labored breathing pattern, dyspnea, motility reduced, limp, flaccid hindlimbs, prostration, emaciation, chromodakryorrhea, decreased body weights, hypothermia). The onset of neuromuscular signs appears to occur in a delayed manner. With regard to the respirability of the aerosol generated the recommendations in the OECD 403 were fulfilled, i.e. the MMAD was in the range of 1 - 4 µm and the GSD between 1.5 to 3  (MMAD = 1.97 - 3.32 µm, GSD = 1.97 - 2.31).

In summary, the aerosolized test substance (dust) proved to have a low to moderate acute inhalation toxicity to rats. Specific pathognomonic findings indicating a causal relationship between exposure concentration and mortality cannot be deduced from the findings obtained.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Physical form:

inhalation: dust / mist

Quality of whole database:

The available information comprises an adequate and reliable (Klimisch score 1) study and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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:

2010/03 to 2010/06

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:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Acclimatization period: at least 5 days.
- Age: 8 weeks Approximately.
- Water: tap water, ad libitum
- Weight at dosing: 372-387 g males and 217-242 g females.
- Housing: During the acclimation period, one to seven animals of the same sex were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). During the treatment period, the animals were housed individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm). Each cage contained autoclaved sawdust.

ENVIRONMENTAL CONDITIONS
- Temperature (22 ± 2°C):
- Humidity (30 to 70%):
- Air changes (per hr): Approximately 12
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: 9 to 24 March 2010

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

A single dose of 2000 mg/kg of the propineb in its original form was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of purified water) and then applied to an area of the skin representing approximately 10% of the total body surface of the animals, calculated according to Meeh's formula (i.e. approximately 5 cm x 7 cm for the males and 5 cm x 6 cm for the females).

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/group

Control animals:

no

Details on study design:

previous non GLP study, in which the cutaneous LD50 of the test item was higher than 2000 mg/kg. Therefore, a limit test was carried out by administering 2000 mg/kg to one group of ten animals (five males and five females).

On the day before treatment, the dorsal area of each animal was clipped (i.e. approximately 5 cm x 7 cm for males and 5 cm x 6 cm for females) using an electric clipper. Only animals with healthy intact skin were used for the study.

Statistics:

The data did not warrant statistical analysis

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred at 2000 mg/kg bw, the only dose level tested.
The dermal LD50 for males was > 2000 mg/kg bw
for females was > 2000 mg/kg bw
for the combined sexes was > 2000 mg/kg bw.

Clinical signs:

other: other: No systemic clinical signs were noted in any animal. A yellow coloration of the skin was noted in all animals between day 2 and day 15. This coloration masked the evaluation of cutaneous reactions in all animals on day 2, in 2/5 males and 1/5 femal

Gross pathology:

No abnormalities were observed at gross necropsy.

Table 1

Doses, toxicological results* / animals treated

Dose (mg/kg bw)	Male	Female	Combined
2000	0/0/5	0/0/5	0/0/10

* :   number of animals which died spontaneously and/or were sacrificed in moribund state/number of animals with signs of toxicity/total number of animals used per group

Interpretation of results:

GHS criteria not met

Conclusions:

The objective of this study was to evaluate the toxicity of the test item, Propineb,
following a single dermal application to rats according to OECD (No. 402, 24th February 1987)
and Commission Regulation (EC) (No. 440/2008, Part B.3, 30 May 2008) guidelines.
The study was conducted in compliance with the principles of Good Laboratory Practice. The test item, in its original form, was applied for 24 hours to the skin of one group of
ten Sprague-Dawley rats (five males and five females) treated at the dose-level of 2000 mg/kg.
The test site was then covered by a semi-occlusive dressing. The dermal LD50 of the test item, Propineb, was higher than 2000 mg/kg bw in male and female rats.

Executive summary:

The objective of this study was to evaluate the toxicity of the test item, Propineb (AE F074263), following a single dermal application to rats according to OECD (No. 402, 24th February 1987) and Commission Regulation (EC) (No. 440/2008, Part B.3, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice.

The test item, in its original form, was applied for 24 hours to the skin of one group of ten Sprague-Dawley rats (five males and five females) treated at the dose-level of 2000 mg/kg bw. The test site was then covered by a semi-occlusive dressing.

Mortality, clinical signs and body weight gain were checked for a period of 14 days following the single application of the test item. On completion of the observation period, the animals were sacrificed then subjected to a macroscopic post-mortem examination. The interpretation of results was carried out according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations).

No deaths and no systemic clinical signs were observed during the study. A yellow coloration of the skin was noted in all animals between day 2 and day 15. This coloration masked the evaluation of cutaneous reactions in all animals on day 2, in 2/5 males and 1/5 females from day 3 until day 5 and in one male until day 9. An erythema was observed in 1/5 males on day 3 and 1/5 females from day 3 until day 5.

When compared to CIT historical control data, a lower body weight gain was noted in 1/5 females between day 1 and day 8 (9 g vs. 25 ± 11 g, in control data base) and in 4/5 males between day 1 and day 8 (17 to 37 g vs. 47 ± 7 g, in control data base) and between day 8 and day 15 (36 to 42 g vs. 51 ± 8 g, in control data base). The body weight gain of the other animals was not affected by treatment with the test item. No apparent abnormalities were observed at necropsy in any animal.

Under the experimental conditions of this study, the dermal LD50 of the test item, Propineb, was higher than 2000 mg/kg in rats. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), concerning the potential toxicity by dermal route, the test item should not be classified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 1-2) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

A key oral acute toxicity study according to OECD 423 and GLP is available (M-370055-01-2). Propineb was administered by oral route (gavage) to 2 groups of six fasted Sprague-Dawley rats (three males and three females) at the dose-level of 2000 mg/kg bw. The test item was prepared in 0.5% (w/v) Methylcellulose/0.4% (w/v) Tween 80 in purified water. No mortalities and no clinical signs were observed. At necropsy no abnormalities were observed. The oral LD50 cut-off was 5000 mg/kg bw. In addition a supporting study (pre-GLP, similar to OECD 401; M-116192-01-1) is available resulting in an oral LD50 of > 5000 mg/kg bw.

A key acute dermal toxicity study according to OECD 402 and GLP is available (M-370058-01-1). A single dose of 2000 mg/kg bw of the test item in its original form was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of purified water) and then applied to an area of the skin representing approximately 10% of the total body surface of the animals. The test item and the gauze pad were held in contact with the skin for 24 hours by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. No mortalities occurred at 2000 mg/kg bw, the only dose level tested. No systemic clinical signs were noted in any animal. A yellow coloration of the skin was noted in all animals between day 2 and day 15. This coloration masked the evaluation of cutaneous reactions in all animals on day 2, in 2/5 males and 1/5 females from day 3 until day 5 and in one male until day 9. Erythema was observed in 1/5 males on day 3 and 1/5 females from day 3 until day 5. No abnormalities were observed at gross necropsy. The dermal LD50 of the test item was thus greater than 2000 mg/kg bw in male and female rats. In addition a supporting study (pre-GLP, similar to OECD 402; M-116192-01-1) is available resulting in a dermal LD50 of > 5000 mg/kg bw.

A key acute inhalation toxicity study according to OECD 403 and GLP is available (M-062776-01-1). Groups of 5 male and 5 female rats were nose-only exposed to average solid aerosol (dust) concentrations of 470, 1043 and 2420 mg/m³ air. With regard to the respirability of the aerosol generated OECD 403 recommendations such were fulfilled, i.e. the MMAD was in the range of 1 - 4 μm and the GSD between 1.5 to 3  (MMAD = 1.97 - 3.32 µm, GSD = 1.97 - 2.31). Exposure to a dust concentration of 470 mg/m³ was tolerated without mortality and rats merely showed transient and minimal clinical signs, such as limp appearance, decrease in body weights and hypothermia. Exposure to 1043 and 2420 mg/m³ resulted in delayed type mortality between the forth or eighth post exposure day. In these exposure groups signs were observed up to post exposure day 15 (major signs included: bradypnea, labored breathing pattern, dyspnea, motility reduced, limp, flaccid hind-limbs, prostration, emaciation, chromodacryorrhea, decreased body weights, hypothermia). The onset of neuromuscular signs appears to occur in a delayed manner. The LC50 for males is > 2420 mg/m³ and in females ~983 (658-1468) mg/m³ air.  The results of the acute inhalation study showed that propineb LC₅₀ is 983 mg/m³ air in females and 2420 mg/m³ air in males.  These results would lead to classification of propineb in Category 3 (H331: Toxic if inhaled) for inhalation toxicity according to the criteria of the CLP Regulation. However, additional investigations (Kiesling & Herrmann, 2003; M-102670-02-1) were conducted to analyse the proportion of the respirable particles generated in the experimental aerosol vs. those generated during the handling of the plant protection products containing propineb.  Results indicate that the aerosol generated under the optimized condition of the acute inhalation bioassay are not representative of the conditions generated under normal handling and use of the plant protection products containing propineb.  Propineb is therefore classified for acute inhalation toxicity in Category 4 (H332: Harmful if inhaled), as indicated in the 2016 EFSA Conclusion on the PPP uses of propineb.

Justification for classification or non-classification

The available data on acute oral and dermal toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.  The available data on acute inhalation toxicity meet the criteria for classification according to Regulation (EC) 1272/2008. Taking into account particle size, propineb is classified for acute inhalation toxicity in Category 4 (H332: Harmful if inhaled).