Cyclopropanecarboxylic acid, 3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propen-1-yl]-2,2-dimethyl-, (1R,3R)-rel-

Endpoint summary

Description of key information

Oral: LD50 > 4990 mg/kg bw, male/female, rat, method similar to OECD401, Southwood 1984b
Dermal: LD50 > 2000 mg/kg bw, male/female, rat, method similar to OECD401, Southwood 1984b
Inhalation: LC50 > 1.1 mg/L, male/female, rat, method similar to OECD401, Leah & Mould 1987

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:

1984-01 to 1984-06-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Ambiguity in the identification of the batch; purity of the test material was not indicated.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Alderley Park specific pathogen free (SPF) albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5 -7 weeks
- Weight at study initiation: 144 - 182 g (males), 124 - 155 g (females)
- Fasting period before study: 16 - 20 hours
- Housing: 5 per cage, in stainless steel cages, 370 x 320 x 200 mm; floor and back: 12 mm square mesh, door: Makrolon (polycarbonate);
- Water: tap water ad libitum, via an automatic system
- Acclimation period: >= 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 21°C, constantly recorded
- Humidity (%): approx. 55% relative, constantly recorded
- Air changes (per hr): 20 - 30
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: not reported

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

suspension

Details on oral exposure:

VEHICLE
- Concentration in vehicle: nominal 100, 200, 500 mg/mL, analytically determined 97, 202, 499 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight, except males at 1000 mg/kg, which received 11 mL/kg.
- Justification for choice of vehicle: not reported
- Lot/batch no. (if required): not reported
- Purity: not reported

MAXIMUM DOSE VOLUME APPLIED: 11 mL/kg
- Rationale for the selection of the starting dose: Results from preliminary study with small number of animals (not further specified)

Doses:

nominal: 1000 (males only), 2000, 5000 mg/kg
analytically determined: 1067 (dosing volume adjusted to low analytical concentration), 2020, 4990 mg/kg

No. of animals per sex per dose:

5 males, 5 females

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations on day 1: twice (30-90 min and 4-6 h after dosing); once daily thereafter; weighing: day -1 (before fasting and application), days 1, 3, 6 (or 4, in lowest dose group), 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

None

Preliminary study:

No details reported; used to set three nominal doses for main study (1000, 2000, 5000 mg/kg body weight)

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 4 990 mg/kg bw

Based on:

test mat.

Remarks:

analytical determination

Remarks on result:

other: Maximum mortality 2/5 at 2020 mg/kg bw, lower mortality (1/5) at 4990 mg/kg bw, no meaningful statistical calculation possible

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 4 990 mg/kg bw

Based on:

test mat.

Remarks:

analytical determination

Remarks on result:

other: Maximum mortality 2/5 at 4990 mg/kg bw, no meaningful statistical calculation possible

Mortality:

All deaths occurred within 48 hours after application.
Males: 0/5 at 1067 mg/kg bw, 2/5 at 2020 mg/kg bw, 1/5 at 4990 mg/kg bw
Females: 0/5 at 2020 mg/kg bw, 2/5 at 4990 mg/kg bw

Clinical signs:

other: Most common signs of toxicity: decreased activity, piloerection, dehydration and signs of urinary incontinence, stains (partially bloody) around the nose, upward curvature of the spine. In the lowest dose group (1067 mg/kg bw, males only), symptoms start

Gross pathology:

No macroscopic abnormalities were observed.

Other findings:

None reported

Table 1: Cumulative mortality

Sex	Day	1067	2020	4990
		mg/kg bw	mg/kg bw	mg/kg bw
Males	1	0/5	2/5	0/5
	2	0/5	2/5	1/5
	15	0/5	2/5	1/5
Females	1	not tested	0/5	0/5
	2	not tested	0/5	2/5
	15	not tested	0/5	2/5

Table 2: Mean body weight and standard deviation (SD)

Sex	Dose		Day:							BW gain
	mg/kg bw		-1	1	3	4	6	8	15	survivors
M	1067	Mean bw	154.2	133.8	162.4	171.2		205.2	265.0	110.0
		+/- SD	13.9	13.6	10.7	10.6		11.8	14.0
M	2020	Mean bw	169.4	148.4	174.3		201.7	217.7	274.3	97.0
		+/- SD	11.4	9.4	12.5		11.1	15.0	16.2
M	4990	Mean bw	167.0	145.4	162.0		189.0	200.0	264.8	100.0
		+/- SD	9.5	10.6	9.4		5.6	5.7	8.7
F	2020	Mean bw	138.0	119.0	141.2		157.6	164.8	196.6	59.0
		+/- SD	6.0	5.6	6.8		9.0	7.5	9.2
F	4990	Mean bw	136.2	117.4	128.3		150.0	156.0	188.7	57.0
		+/- SD	11.6	11.5	6.4		11.1	8.7	11.8

Table 3: Clinical observations: Number of animals affected and days of occurrence

Clinical observations Males	group 03		group 01		group 02
mg/kg bw	1067		2020		4990
Males: number of animals	5		5		5
	animals	days	animals	days	animals	days
activity decreased		1	2	1	4	1-4
found dead	0		2	1	1	2
killed termination	5	15	3	15	4	15
signs of diarrhoea	1	3	0	3	0
splayed gait	1	1	0		1	1
reduced stability	3	1	2	1	3	1-2
tip toe gait	0		1	1	1	1
chromodacryorrhea	0		0		2	2-3
abdominal tone decreased	0		1	1	2	1
dehydrated	2	1	3	1-2	4	1-4
piloerection	1	1	0		3	1-5
salivation	0		0		3	1
sides pinched in	3	1	2	1	3	1-2
signs of salivation	2	1	2	1-2	2	1-3
stained around mouth	0		0		1	1-2
stains around nose	2	1	3	1-4	5	1-4
signs of urinary incontinence	2	2-4	3	2-5	4	1-5
ungroomed	0		1	1	2	2-4
urinary incontinence	0		3	1	2	1
upward curvature of spine	4	1-2	3	1-3	4	1-3
reduced righting reflex	0		1	1	2	1
breathing depth increased	0		0		1	1
breathing rate reduced	0		0		1	1

Clinical observations Females			group 01		group 02
mg/kg bw	1067		2020		4990
Females: number of animals	0		5		5
	animals	days	animals	days	animals	days
activity decreased			3	1	4	1-3
bizarre behaviour			0		1	1
tremors			0		1	1
found dead			0		2	2
killed termination			5	15	3	15
diarrhoea			1	1	0
reduced stability			3	1	3	1
chromodacryorrhea			0		1	2
abdominal tone decreased			0		3	1
dehydrated			4	1-4	5	1-3
hypothermia			0		2	1
piloerection			2	1-2	5	1-11
salivation			1	1	0
sides pinched in			3	1	4	1
signs of salivation			4	1-2	5	1-2
stains around nose			3	1-2	5	1-4
signs of urinary incontinence			3	2-4	3	1-7
ungroomed			1	3-4	3	1-4
urinary incontinence			2	1	3	1-2
hair loss (general)			0		1	6-15
upward curvature of spine			3	1	5	1-3
reduced righting reflex			1	1	3	1
breathing depth increased			1	1	1	1
breathing rate reduced			0		2	1
breathing depth reduced			1	1	1	1

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of the test substance was estimated to be greater than 4990 mg/kg bw to male and female rats. Confidence limits could not be calculated. The study report is relevant, reliable with restrictions and adequate for risk assessment, classification and labeling.

Executive summary:

The acute oral toxicity of the test material (a powder) was assessed according to a method similar to OECD 401 in groups of five male and five female rats, at doses of 1067 (males only), 2020, and 4990 mg/kg body weight (bw). The test substance was applied as a suspension in corn oil by oral gavage. Mortalities, signs of toxicity, and body weight development were recorded during 15 days; survivors were examined by necropsy for macroscopic abnormalities.

Mortalities in all dose groups up to 4990 mg/kg bw were less than 50% (1/5 or 2/5 animals), so that a statistical calculation of the LD50 (by interpolation) could not be performed. The most common clinical symptoms were decreased activity, piloerection, dehydration, signs of urinary incontinence, stains around the nose, and upward curvature of the spine. They subsided within 3 - 7 days, except for one high-dose male. Body weights initially decreased (due to fasting), but reached their initial values around day 4 - 6 after treatment and increased normally thereafter. No macroscopical abnormalities were detected.

The author estimates an acute oral LD 50 of > 4990 mg/kg bw to male and female rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 990 mg/kg bw

Quality of whole database:

The study is GLP compliant with Klimisch score 2.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1986-10 to 1987-02-24

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Limit concentration of 5 mg/L or recommended concentration of 2 mg/L not reached, and no rationale given. Mass median aerodynamic diameter of aerosols >4 micrometer (5.3 and 7.3 micrometer, at lower and higher concentration, respectively).

GLP compliance:

yes

Remarks:

Summary report derived from a study which fulfills the requirements of GLP; not further documented

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Alpk:AP

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not reported
- Age at study initiation, weight at study initiation: not reported
- Fasting period before study: not reported
- Housing, diet, water: not reported
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- not reported

IN-LIFE DATES: From: To: not reported

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus, chamber volume, method of holding animals in test chamber: not reported
- Source and rate of air, conditioning air: not reported
- System of generating particulates/aerosols: Wright's dust feed
- Method of particle size determination: Marple cascade impactor
- Treatment of exhaust air: not reported
- Temperature, humidity, pressure in air chamber: not reported

TEST ATMOSPHERE
- Brief description of analytical method used: 25mm open-faced filters, gravimetric determination likely (since no reference to analytical method is given)
- Samples taken from breathing zone: no data

VEHICLE
- none

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
at 0.09 mg/L: 84% inhalable (<= 15 micrometer aerodynamic equivalent diameter AED), 23% respirable (<= 2.5 micrometer AED);
at 1.1 mg/L: 79% inhalable (<= 15 micrometer AED), 12% respirable (<= 2.5 micrometer AED);
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD at 0.09 mg/L: 5.3 micrometer, at 1.0 mg/L: 7.3 micrometer; GSD not reported
- Rationale for the selection of the starting concentration: none given

Analytical verification of test atmosphere concentrations:

yes

Remarks:

no analytical method reported; probably gravimetric

Duration of exposure:

4 h

Concentrations:

nominal: 0.1 and 1.0 mg/L
analytical: 0.09 +/- 0.01 mg/L and 1.1 +/- 0.1 mg/L

No. of animals per sex per dose:

5 males and 5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights (lungs and liver)

Statistics:

None (no mortalities observed)

Preliminary study:

None reported

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

>= 1.1 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

>= 1.1 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: No mortalities observed

Mortality:

None observed

Clinical signs:

other: Animals exposed to the high concentration had test material around their snouts. Stains around the snout, chromodacryorrhea and wet fur during exposure, as well as hunched posture and piloerection immediately following exposure were observed both in the t

Body weight:

No average or individual data are presented in the report. No toxicologically significant effects on body weight or weight gain were observed.

Gross pathology:

No significant macropathological changes were observed in the treated animals.

Other findings:

- Organ weights: At 1.1 mg/L, the liver/body weight ratio was statistically significantly lowered in males, although the reduction was very small (7%, with no associated clinical or post-mortem findings). All other organ weights (absolute and relative) were normal. Neither average nor individual values are tabulated in the report.

Interpretation of results:

other: not conclusive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute inhalation LC50 of the test substance was estimated to be greater than 1.1 mg/L to male and female rats. Confidence limits could not be calculated. The study report is relevant, but not adequate and reliable for classification and labeling.

Executive summary:

The acute inhalation toxicity of the test material (a powder) was assessed according to a method similar to OECD 403 in groups of five male and five female rats, at analytical aerosol concentrations of 0.1 mg/L and 1.1 mg/L. The test substance aerosols were generated using a Wright’s dust feed, quantified by deposition on 25 mm open-faced filters, and their particle size distribution was assessed with a Marple cascade impactor. The mass median aerodynamic diameters obtained were 5.3 micrometer at 0.1 mg/L, and 7.3 micrometer at 1.1 mg/L. No attempt to reach the aerosol concentration recommended in OECD 403 (2 mg/L) or the limit test condition (5 mg/L) was reported. Mortalities, signs of toxicity, body and organ (lung and liver) weight developments were recorded during 14 days; survivors were examined by necropsy for macroscopic abnormalities.

Mortalities were not observed, so that a statistical calculation of the LC50 could not be performed. The clinical symptoms, stains around the nose, piloerection, and hunched posture, though persisting up to day 15, were considered a mild, non-specific response to exposure. Body and organ weights developed normally, except for a slight but statistically significant decrease (7%) of the relative liver weight in the males of the higher concentration group. No macroscopical abnormalities were detected.

From the absence of mortalities (LC0>1.1 mg/L), the acute inhaltation LC50 > 1.1 mg/L was estimated.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

1 100 mg/m³ air

Quality of whole database:

The study is GLP compliant with Klimisch score 3.

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:

1984-01 to 1984-06-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Ambiguity in the identification of the batch; purity of the test material not indicated; inconsistent duration of exposure (contact period): 24 or 27 hours.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Alderley Park specific pathogen free (SPF) albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5 -7 weeks
- Weight at study initiation: 277 - 312 g (males), 200 - 235 g (females)
- Fasting period before study: 16 - 20 hours
- Housing: individual, 2 per cage (separated by a solid metal partition, 1 animal per compartment) in stainless steel cages, 370 x 320 x 200 mm; floor and back: 12 mm square mesh, door: Makrolon (polycarbonate);
- Water: tap water ad libitum, via an automatic system
- Acclimation period: >= 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 21°C, constantly recorded
- Humidity (%): approx. 55% relative, constantly recorded
- Air changes (per hr): 20 - 30
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: not reported

Type of coverage:

occlusive

Vehicle:

sorbitan derivative

Remarks:

0.3 mL of a 0.5% polysorbate 80 solution

Details on dermal exposure:

TEST SITE
- Hair removal, by clipping, 100 x 50 mm on dorso-lumbar area
- Area of exposure: patch size approx. 75 x 50 mm
- % coverage: not reported
- Type of wrap if used: aluminium foil patch , kept in place using adhesive impermeable tape (approx. size 250 x 75 mm)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin cleansed using swabs of absorbent cotton wool soaked in clean warm water, then dried with tissue paper
- Time after start of exposure: 24 or 27 hours; the report is inconsistent, it states "kept in contact for 24 hours" and a "27-hour contact period"

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight (bw)
- Concentration (if solution): not reported; solid test substance weighed out onto an aluminium patch, then moistened with 0.3 mL of 5% polysorbate 80
- Constant volume or concentration used: yes (constant volume of 5% polysorbate 80)
- For solids, paste formed: yes

VEHICLE
- Amount applied (volume or weight with unit): 0.3 mL
- Concentration (if solution): 0.5%
- Lot/batch no. (if required): not reported
- Purity: not reported

Duration of exposure:

24 or 27 hours; the report is inconsistent, it states "test substance kept in contact with the skins for 24 hours" and a "27-hour contact period" in two subsequent paragraphs

Doses:

2000 mg/kg body weight (bw)

No. of animals per sex per dose:

5 males, 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations on day 1: once (between 1 and 4 h after dosing); once daily thereafter; weighing: day 1 (before application), days 3, 6, 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

none (limit test)

Preliminary study:

No details reported; used to set the nominal dose for the limit test main study (2000 mg/kg body weight)

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality

Mortality:

None

Clinical signs:

other: Signs of systemic toxicity (mostly on day 2 only): diarrhoea, stains around the nose, signs of urinary incontinence, and upward curvature of the spine. The stains persisted in one female until day 5. Signs of skin irritation: - scab formation (at edge of

Gross pathology:

No macroscopic abnormalities were observed.

Other findings:

None reported.

Table 1: Mean body weight and standard deviation (SD)

Sex	Dose		Day:					BW gain
	mg/kg bw		1	3	6	8	15
M	2000	Mean bw	293.6	279.6	292.6	309.6	331.4	37
		+/- SD	12.4	12.3	14.6	15.3	15.6
F	2000	Mean bw	213.6	209.4	215.4	222.6	234.8	21
		+/- SD	13.4	7.9	12.2	14.2	11.6

Table 2: Clinical observations: Number of animals affected and days of occurrence

Clinical observation	Males		Females
mg/kg bw	2000		2000
	animals	days	animals	days
number of animals	5		5
killed at termination	5	15	5	15
signs of diarrhoea	1	2	1	2
stains around nose	1	2	3	2-5
signs of urinary incontinence	1	2	3	2
urinary incontinence	0		1	2
upward curvature of spine	1	2	0
desquamation	0		3	4-7
skin eruptions ?	2	2-7	0
scab: edge of applic. area	0		2	6-15
scabs: small scattered	1	6-11	1	4-12

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of the test substance was estimated to be greater than 2000 mg/kg bw to male and female rats. Confidence limits could not be calculated (limit test). The study report is relevant, reliable with restrictions and adequate for risk assessment, classification and labeling.

Executive summary:

The acute dermal toxicity of the test material (a powder) was assessed according to OECD 402 in a limit test with five male and five female rats, at a dose of 2000 mg/kg body weight. The test substance was moistened with 0.3 mL of 0.5% polysorbate 80 and applied dermally as a paste, then covered with an occlusive dressing (aluminium foil). Mortalities, signs of toxicity, and body weight development were recorded during 15 days; survivors were examined by necropsy for macroscopic abnormalities.

Mortalities were not observed at this dose. Signs of systemic toxicity were mostly seen on day 2: diarrhea, stains around the nose, signs of urinary incontinence, and upward curvature of the spine. Skin irritation was observed between day 4 and 15 (scab formation in 1/5 male and 3/5 females, slight desquamation in 3/5 females). Body weights initially decreased, but reached their initial values around day 8 after treatment and increased thereafter. No macroscopical abnormalities were detected.

The author estimates an acute dermal LD50 of > 2000 mg/kg bw to both sexes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The study is GLP compliant with Klimisch score 2.

Additional information

Oral:

Only a single oral toxicity study conducted under GLP with a method similar to guideline OECD 401 is available (Southwood 1984b). The study is considered to be relevant, reliable with restrictions and adequate for the purposes of risk assessment, classification and labelling.

Since none of the three doses elicited mortalities above 50% in either sex, the LD50 in rats was extrapolated to be >4990 mg/kg bw (for the test material as supplied).

Dermal:

Only a single dermal toxicity study conducted under GLP according to a method similar to guideline OECD 402 is available (Southwood 1984b). The study is considered to be relevant, reliable with restrictions and adequate for the purposes of risk assessment, classification and labelling.

The dermal LD50 in male and female rats was determined to be > 2000 mg/kg bw, since no mortality was observed (limit test).

Inhalation:

For this endpoint, a summary report (Leah & Mould 1987) of one nose-only dust inhalation study is available, which fulfils the requirements of GLP and follows a method similar to the guideline OECD 403. While the full study report could not be assessed, the results are sufficiently documented and unambiguous.

The study comprised only two exposure concentrations, 0.09 and 1.1 mg/L; no attempt was reported to reach the recommended concentration of 2 mg/L. Mass median aerodynamic diameter of aerosols >4 micrometer (5.3 and 7.3 micrometer, at lower and higher concentration, respectively). No mortalities and no significant signs of toxicity were reported at either concentration; thus the acute inhalation LC50 of the test substance was estimated to be >1100 mg/m3 (1.1 mg/L) to male and female rats.

Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for selection of acute toxicity – inhalation endpoint
Only one study available

Justification for selection of acute toxicity – dermal endpoint
Only one study available

Justification for classification or non-classification

Data were available for the test item administered by the oral, inhalation and dermal routes of exposure.

Given the deviations in the study on acute inhalation toxicity (no attempt to reach the recommended concentration of 2 mg/L, tested substance with particle size with a Mass median aerodynamic diameter of aerosols >4 micrometer) its results are not considered to be adequate for classification and labelling purpose.

Both available studies on acute oral and dermal toxicity are considered adequate and reliable for the purposes classification and labelling.

 

Acute oral toxicity

The acute oral toxicity, LD50>4990 mg/kg bw, does not lead to the classification of the substance, according to the criteria in Directive 2001/59/EC, Annex VI, 3.2 and according to the criteria for classification under Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.1.2.

 

Acute dermal toxicity

The acute dermal toxicity, LD50>2000 mg/kg bw, does not lead to the classification of the substance, according to the criteria in Directive 2001/59/EC, Annex VI, 3.2 and according to the criteria for classification under Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.1.2.