N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide

Endpoint summary

Description of key information

Acute Oral Toxicity

According to the OECD Test Guideline 425 Acute Oral Toxicity Statistical Program, the LD50 of MGK 264 was determined to be equal to 5000 mg/kg with a 95% confidence interval of 2736 to 6360 mg/kg.

The acute oral median lethal dose (LD50) of the test material, in female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)

Inhalation Toxicity

Under the conditions of this test, the acute inhalation LC50 of MGK 264 in the male rat was determined to be 1.94 mg/L. In the female rat, the acute inhalation LC50 was determined to be 1.94 mg/L. In the sexes combined, the LC50 was determined to be 1.98 mg/L.

The acute inhalation lethal dose (LC50) of the test material, in female Sprague-Dawley rats (1.94 mg/L) was found to be between 1.0 and 5.0 mg/l. According to EC 1272/2008 this would be classified as a category 4 toxicity hazard for inhalation.

Dermal Toxicity

The acute dermal lethal dose (LD50) of the test material, in male and female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)

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:

17 November 2004 to 26 April 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Version / remarks:

December 17,2001

Deviations:

not specified

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Specific details on test material used for the study:

MGK® 264
Lot No.: AA 7093
Purity: 95.2% MGK 264 (From CofA)

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Animals
Adult, Hsd: Sprague Dawley® SD® rats were received from Harlan Sprague Dawley, Inc., Indianapolis, IN. Upon receipt, metal ear tags displaying unique identification numbers were used to individually identify the animals. Cage cards displaying at least the study number, animal number and sex were affixed to each cage.
Environment
The animal room temperature and relative humidity ranges were 56-72°F (13-22°C) and 14-61 %, respectively. Environmental control equipment was monitored and adjusted as necessary to minimize fluctuations in the animal room environment. Light timers were set to maintain a 12-hour lightll2-hour dark cycle and room ventilation was set to produce 10-15 air changes/hour. The animal room temperature and relative humidity were recorded a minimum of once daily.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Limit Test was dosed at 5000 mg/kg
Dose Levels of 175; 550; 1750 and 5000 mg/kg in the main study

No. of animals per sex per dose:

1 animal (female) for Limit Test
15 animals (all Female) for Up/Down Study

Control animals:

no

Details on study design:

The animals chosen for study use were randomly selected from healthy stock animals using a computerized random numbers table to avoid potential bias. All animals received a detailed pretest observation prior to dosing. Only healthy animals were chosen for study use. Females were nulliparous and nonpregnant. The female animals were approximately 9-12 weeks of age and weighed 176-206 grams prior to dosing.

On the day prior to dosing (day -1), the animals chosen for the study were weighed and fasted. On the day of dosing (day 0), the test article was administered orally as a single dose using a ball tipped stainless steel gavage needle attached to a syringe.

The animals were observed for clinical abnormalities a minimum of two times on study day 0 (post-dose) with the first observation within approximately 30 minutes after dosing and daily thereafter (days 1-14). A mortality check was performed twice daily, in the morning and afternoon.
Individual body weights were obtained for the test animals prior to fasting (day -I), prior to dosing on day 0 and on days 7 and 14. Animals found dead after day 0 were also weighed.

Statistics:

After each level was conducted, the short-term and long-term outcome (results) were input into the OECD 425 AOT Statistical Program. When the stopping criteria were engaged, the LD50 and the 95% confidence intervals were calculated using a computer program provided by the OECD (OECD 425 AOT program). Body weight means and standard deviations were calculated (as appropriate).
The results of the study were used to place the test article in the appropriate EPA Toxicity Category for labeling.

Preliminary study:

Limit Test. 1 female animal dosed at 5000 mg/kg, due to mortality, the limit test was discontinued and an up/down study was initiated.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

95% CL:

> 2 736 - < 6 360

Remarks on result:

other: Under the conditions of this test and based on the OECD 425 AOT Statistical Program, the acute oral LD50 of MGK® 264 was determined to be equal to 5000 mg/kg in the rat with a 95% confidence interval of 2736 to 6360.

Mortality:

Limit Test-
The female does at 5000 mg/kg for the limit test was found dead on day 1.

Up/Down test
For the 175 mg/kg dose level, no mortality occurred.
For the 550 mg/kg dose level, no mortality occurred.
For the 1750 mg/kg dose level, no mortality occurred.
For the 5000 mg/kg dose level, mortality occurred by study day 3. (5/7 animals were deceased)

Clinical signs:

For the 175 mg/kg dose level, no clinical observations were observed during the study.
For the 550 mg/kg dose level, no mortality occurred. Clinical observations during the study included transient incidences of congested breathing and salivation.
For the 1750 mg/kg dose level, no mortality occurred. Clinical observations during the study included transient incidences of congested breathing, few feces, feces small in size, salivation and dark material around the facial area. An additional observation of ocular lesion was noted in one animal that did not resolve by the time of scheduled necropsy on study day 14.
For the 5000 mg/kg dose level the most notable clinical abnormalities observed for the animals that died included decreased activity, wobbly gait, muscle spasms, impaired mobility, hyperextension of the limbs, rigid upon handling, intermittent tremors, congested breathing, labored breathing, slow breathing, shallow breathing, few feces, feces small in size, no feces, soft stools, urine stain, rough coat, cool to tough, hunched posture, piloerection, ocular discharge, eyelids partially closed, dilated pupils, pale eyes, salivation, dark material around the facial area, and decreased food consumption. For the animals that survived, the most notable clinical observations included transient incidences of decreased activity, wobbly gait, rigid upon handling, intermittent tremors, increased reactivity to handling, overt aggressiveness, circling motion (to the left), congested breathing, labored breathing, few feces, feces small in size, urine stain, rough coat, hunched posture, hairloss, piloerection, dehydration, unkempt appearance, swelling in the facial area, dark material around the facial area, salivation, and decreased food consumption.

Body weight:

For the 175 mg/kg dose level, body weight gain was noted for the animal during the test period.
For the 550 mglkg dose level, body weight gain was noted for the animal during the test period.
For the 1750 mglkg dose level, body weight gain was noted for all animals during the test period.
For the 5000 mg/kg dose level there were two surviving animals by day 14. Body weight loss was noted in 1/2 surviving animals during the study day 0 to 7 body weight interval. Body weight gain was noted for the other surviving animal during the test period.

Gross pathology:

For the 175 mg/kg dose level, no gross internal findings were observed at the time of scheduled necropsy on study day 14.
For the 550 mglkg dose level, no gross internal findings were observed at the time of scheduled necropsy on study day 14.
For the 1750 mglkg dose level, no gross internal findings were observed at the time of scheduled necropsy on study day 14.
For the 5000 mg/kg dose level, gross internal findings observed at necropsy included mottled lung, small thymus, distended stomach, and abnormal content in the small intestine.

Following are available in full in the attached report and as single pages in the background meterial attachments:

Table 1 - Summary of Mortality

Table 2 - Summary of Clinical Observations (2 pages)

Table 3 - Summary of Body Weight Data Grams

Table 4 - Summary of Gross Necropsy Observations (3 pages)

Table 5 - AOT results (2 pages)

Interpretation of results:

other: No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)

Conclusions:

According to the OECD Test Guideline 425 Acute Oral Toxicity Statistical Program, the LD50 of MGK 264 was determined to be equal to 5000 mg/kg with a 95% confidence interval of 2736 to 6360.

The acute oral median lethal dose (LD50) of the test material, in female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)

Executive summary:

Under the conditions of this test and based on the OECD 425 AOT Statistical Program, the acute oral LD50 of MGK® 264 was determined to be equal to 5000 mg/kg in the rat with a 95% confidence interval of 2736 to 6360. The test article would be assigned an EPA-OPPTS Toxicity Category III for labeling.

According to the OECD Test Guideline 425 Acute Oral Toxicity Statistical Program, the LD50 of MGK 264 was determined to be equal to 5000 mg/kg with a 95% confidence interval of 2736 to 6360.

The acute oral median lethal dose (LD50) of the test material, in female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Database considered realiable. Justification - data is based on two GLP guideline studies.

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:

17 November 2004 to 21 April 2005

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:

May 12, 1981

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Version / remarks:

August 1998

Deviations:

not specified

GLP compliance:

yes

Test type:

traditional method

Limit test:

no

Specific details on test material used for the study:

MGK® 264
Lot No.: AA7093
Purity: 95.2% MGK 264 (From CofA)

Lot No. AA7207 - addtional shipment required to complete the study
Purity: 99.04%

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals
Young adult, Hsd: Sprague Dawley SD rats were received from Harlan Sprague Dawley Inc., Indianapolis, Indiana.
Environment
The animal room temperature and relative humidity ranges were 65-72°F (18-22°C) and 34-59%, respectively. Environmental control equipment was monitored and adjusted as necessary to minimize fluctuations in the animal room environment. Light timers were set to maintain a 12-hour light/12-hour dark cycle and room ventilation was set to produce 10-15 air changes/hour. The animal room temperature and relative humidity were recorded a minimum of once daily.

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: Conditioned external air

Mass median aerodynamic diameter (MMAD):

>= 2.2 - <= 3.6 µm

Geometric standard deviation (GSD):

>= 1.94 - <= 2.46

Remark on MMAD/GSD:

For 0.55mg/L dose MMAD = 2.2µ, GSD=1.94
For 0.55mg/L dose MMAD = 3.6µ, GSD=2.10
For 0.55mg/L dose MMAD = 3.0µ, GSD=2.46

Details on inhalation exposure:

The aerosol exposures consisted of a 21-minute (0.55 and 2.23 mg/L dose level) or an 18-minute (1.01 mg/L dose level) T99 equilibration period, a 240-minute exposure period and a 21-minute (0.55 and 2.23 mg/L dose level) or an 18-minute (1.01 mg/L dose level) de-equilibration period equal to the T99 equilibration period. After the aerosol exposure, the animals were removed from the chamber and residual test article was removed from the animal's exterior surfaces (where practical) by rinsing the haircoat with lukewarm tap water and wiping the haircoat with a dry towel. The animals were then returned to ad libitum feed and water.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

the concentration of the test item aerosol was ollected in the inhalation chamber by gravimetric technique.

Duration of exposure:

240 min

Concentrations:

0.55, 1.01 and 2.23 mg/L

No. of animals per sex per dose:

5 Male, 5 Female per dose level

Control animals:

no

Details on study design:

The 4h whole-body inhalation toxicity of MGK® 264 was evaluated in Sprague Dawley rats. A LC50 study was performed in which three groups of five male and five female rats received a 4h whole-body inhalation exposure to a time-weighted average aerosol concentration (gravimetrically determined). Following the exposure, the rats were observed daily and weighed weekly. A gross necropsy examination was performed on all test animals at the time of scheduled euthanasia (day 14).

Statistics:

The LC50 and 95% confidence intervals were calculated separately for males, females and the combined sexes using a computer adaptation of the method of Litchfield and Wilcoxon.

Body weight means and standard deviations were calculated separately for males and females. The aerodynamic particle-size distribution of the test article aerosol was plotted using an Excel computer adaptation of the three cycle logarithmic probability paper as per the ITP Cascade Impactor instruction manual. The mass median aerodynamic diameter, geometric standard deviation and particles S 4.0 11 were determined based on the plotted distribution.

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

1.98 mg/L air

Based on:

test mat.

95% CL:

> 1.506 - < 2.606

Exp. duration:

240 min

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

1.94 mg/L air

Based on:

test mat.

95% CL:

> 1.233 - < 3.043

Exp. duration:

240 min

Key result

Sex:

female

Dose descriptor:

LC50

Effect level:

1.94 mg/L air

Based on:

test mat.

95% CL:

> 1.233 - < 3.043

Exp. duration:

240 min

Mortality:

No mortality occurred at the 0.55 and 1.01 mglL dose levels.
Mortality occurred by study day 2 for the 2.23 mgIL dose level. 3/5 Males deceased, 3/5 Females deceased.

Clinical signs:

other: For the 0.55 mg/L dose level, clinical abnormalities included breathing abnormalities, decreased defecation, rough haircoat, hunched posture, urine stain, unkempt appearance, swelling around nose, nasal discharge and dark material around the facial area.

Body weight:

For the 0.55 mg/L dose level, body weight gain was noted for all animals during the test period.

For the 1.01 mg/L dose level, slight body weight loss was noted in four males and one female during the day 0 to 7 body weight interval. Body weight gain/maintenance was noted for all other animals during the test period. All animals exceeded their initial body weight by study termination.

For the 2.23 mg/L dose level, slight body weight loss was noted in two surviving males during the day 0 to 7 body weight interval. Body weight gain was noted for all other surviving animals during the test period. All surviving animals exceeded their initial body weight by study termination.

Gross pathology:

For the 0.55 mg/L dose level, no significant gross internal findings were observed at necropsy on study day 14.

For the 1.01 mg/L dose level, no significant gross internal findings were observed at necropsy on study day 14.

For the 2.23 mg/L dose level, the most notable gross internal findings were noted in the animals that died and included foci on the stomach, mottled lung lobes, abnormal content of the digestive tract/trachea/nasal tissues/larynx/urinary bladder, pale liver lobes and dark red kidney. No significant gross internal findings were observed at necropsy on study day 14.

Interpretation of results:

other: EC 1272/2008 this would be classified as a category 4 toxicity hazard for inhalation

Conclusions:

Under the conditions of this test, the acute inhalation LC50 of MGK 264 in the male rat was determined to be 1.94 mg/L. In the female rat, the acute inhalation LC50 was determined to be 1.94 mg/L. In the sexes combined, the LC50 was determined to be 1.98 mg/L.

The acute inhalation lethal dose (LC50) of the test material, in female Sprague-Dawley rats (1.94 mg/L) was found to be between 1.0 and 5.0 mg/l. According to EC 1272/2008 this would be classified as a category 4 toxicity hazard for inhalation.

Signal Word: Warning
Hazard Statement: H332: Harmful if inhaled

Executive summary:

The 4h whole-body inhalation toxicity of MGK® 264 was evaluated in Sprague Dawley rats. A LC50 study was performed in which three groups of five male and five female rats received a 4h whole-body inhalation exposure to a time-weighted average aerosol concentration (gravimetrically determined) of 0.55, 1.01 and 2.23 mg/L, respectively. The mass median aerodynamic diameter and geometric standard deviation of the sampled particles were 2.2 µand 1.94, 3.6 µand 2.1 0, and 3.0 µand 2.46, respectively. The percentage of particles ≤ 4.0 µ was determined to be 82%, 56% and 62%, respectively. Following the exposure, the rats were observed daily and weighed weekly. A gross necropsy examination was performed on all test animals at the time of scheduled euthanasia (day 14).

Under the conditions of this test, the acute inhalation LC50 of MGK 264 in the male rat was determined to be 1.94 mg/L. In the female rat, the acute inhalation LC50 was determined to be 1.94 mg/L. In the sexes combined, the LC50 was determined to be 1.98 mg/L. The test article would be assigned an EPA-OPPTS Toxicity Category III for labelling.

The acute inhalation lethal dose (LC50) of the test material, in female Sprague-Dawley rats (1.94 mg/L) was found to be between 1.0 and 5.0 mg/l. According to EC 1272/2008 this would be classified as a category 4 toxicity hazard for inhalation.

Signal Word: Warning

Hazard Statement: H332: Harmful if inhaled

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

1 980 mg/m³

Quality of whole database:

Database considered realiable. Justification - data is based on GLP guideline 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:

17 November 2004 to 22 Mar 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

August 1998

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February, 1987

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

MGK 264
Lot No.: AA-7093
Purity: 95.2% MGK 264 (From CofA)

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Description, Identification and Housing
Adult, Hsd: Sprague Dawley® SD® rats were received from Harlan Sprague Dawley, Inc., Indianapolis. IN. Upon receipt, metal ear tags displaying unique identification numbers were used to individually identify the animals. Cage cards displaying at least the study number, animal number and sex were affixed to each cage. The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals.
Environment, food and water
The animal room temperature and relative humidity ranges were 64-71°F (18-22°C) and 40-61 %. respectively. Environmental control equipment was monitored and adjusted as necessary to minimize fluctuations in the animal room environment. Light timers were set to maintain a 12-hour Iightll2-hour dark cycle and room ventilation was set to produce 10-15 air changes/hour. The animal room temperature and relative humidity were recorded a minimum of once daily. Food and Water provided ad libitum.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

On the day following clipping of the fur from the dorsal trunk (day 0), the test article was administered dermally to approximately 10% of the body surface area. The four comers of this area were delineated in the clipped area with an indelible marker. The test article was then spread evenly over the delineated test area and held in contact with the skin with an appropriately sized 4-ply porous gauze dressing backed with a plastic wrap which was placed over the gauze dressing (occlusive binding). Removal and ingestion of the test article was prevented by placing an elastic wrap over the trunk and test area. The elastic wrap was further secured with a tape harness on the cranial end of the trunk and then secured with adhesive tape around the trunk at the caudal end.

Duration of exposure:

After an approximate 24-hour exposure period, the binding materials were removed and the corners of the test site were re-delineated using a marker. Residual test article was removed using gauze moistened with deionized water followed by dry gauze.

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 males and 5 females per dose.

Control animals:

no

Details on study design:

The single-dose dermal toxicity of MGK® 264 was evaluated in Sprague Dawley rats. A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test article at a dose of 5000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all animals at the time of scheduled euthanasia (day 14).

Statistics:

Data from the limit test were analyzed and an LD50 value estimated as follows:

< 50% Mortality: LD50 was estimated as greater than the administered dose.
= 50% Mortality: LD50 was estimated as equal to the administered dose.
> 50% Mortality: LD50 was estimated as less than the administered dose.

Body weight means and standard deviations were calculated separately for males and females.

Key result

Sex:

male/female

Dose descriptor:

other: LD50 found to be greater than 5000 mg/kg

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred during the limit test.

Mortality:

No mortality occurred during the limit test.

Clinical signs:

Clinical abnormalities observed during the study included transient incidences of dark material around the facial area and ocular discharge. Dermal irritation was noted at the site of test article application.

Body weight:

Body weight gain was noted for all animals during the test period.

Gross pathology:

No gross internal findings were observed at necropsy on study day 14.

Interpretation of results:

other: No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)

Conclusions:

The acute dermal lethal dose (LD50) of the test material, in male and female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)

Executive summary:

The single-dose dermal toxicity of MGK® 264 was evaluated in Sprague Dawley rats. A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test article at a dose of 5000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all animals at the time of scheduled euthanasia (day 14).

No mortality occurred during the limit test.

The acute dermal lethal dose (LD50) of the test material, in male and female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Database considered realiable. Justification - data is based on GLP guideline study.

Justification for classification or non-classification

Acute Oral Toxicity

According to the OECD Test Guideline 425 Acute Oral Toxicity Statistical Program, the LD50 of MGK 264 was determined to be equal to 5000 mg/kg with a 95% confidence interval of 2736 to 6360. The acute oral median lethal dose (LD50) of the test material, in female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008)

Inhalation Toxicity

Under the conditions of this test, the acute inhalation LC50 of MGK 264 in the male rat was determined to be 1.94 mg/L. In the female rat, the acute inhalation LC50 was determined to be 1.94 mg/L (1940 mg/m3). In the sexes combined, the LC50 was determined to be 1.98 mg/L. The acute inhalation lethal dose (LC50) of the test material, in female Sprague-Dawley rats was found to be between 1.0 and 5.0 mg/l. According to EC 1272/2008 this would be classified as a category 4 toxicity hazard for inhalation.

Dermal Tox

The acute dermal lethal dose (LD50) of the test material, in male and female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008).