Registration Dossier

Administrative data

Description of key information

The substance was assessed for oral and dermal acute toxicity. In the oral toxicity study, concentrations up to 10 g/kg bw were tested and the LD50 oral was determined being 6'176 mg/kg bw. The acute toxicity study by dermal route was performed as a limit test with only one dose of 2'000 mg/kg bw applied, showing no mortality to any of the animals (5 males and 5 females) tested.

Thus, the substance is not subject to classification for acute oral or dermal toxicity according to CLP.

Data for acute inhalation toxicity are not required as the substance is not used as aerosol and due to the low vapour pressure of 0.000045 Pa no relevant vapour exposure is possible.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of 4 albino rats (2 male, 2 female) were administered the test material by gavage at doses of approx. 3, 4.5, 7 and 10 g/kg bw (25% w/v Diacid in corn oil). After treatment, the animals were observed for 14 days for clinical signs. Body weights were measured at start and end of the observation period. Necropsy was performed on all animals.
GLP compliance:
no
Remarks:
study performed prior to GLP
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ARS/Sprague-Dawley, Madison, Wisconsin.
- Age at study initiation: Young rats, no exact age available
- Weight at study initiation: 157 - 191 g
- Fasting period before study: 16 hours
- Housing: Stock cages
- Diet (e.g. ad libitum): Ad libitum, standard laboratory diet
- Water (e.g. ad libitum): Ad libitum, standard water
- Acclimation period: Five days under observation

ENVIRONMENTAL CONDITIONS
No data available
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% w/v
- Amount of vehicle (if gavage): varying per dose group (increased volume for higher dose)
- Justification for choice of vehicle: generally used vehicle
- Purity: No data available
Doses:
- 3,038 mg/kg bw
- 4,556 mg/kg bw
- 6,834 mg/kg bw
- 10,250 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations continuously, weights: initial and final (14 days)
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, necropsy of animals that died during the observation period
Statistics:
The acute oral median lethal dose (LD50) was calculated using interpolation methods described by Weil (1952), Thompson (1947) and Thompson and Weil (1952).
Preliminary study:
Not relevant
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 176 mg/kg bw
Based on:
test mat.
95% CL:
> 5 548.9 - <= 6 803.1
Remarks on result:
other: SD of LD50: ±627.1 mg/kg
Mortality:
No mortality occurred in the two test groups receiving the lowest doses. 3 out of 4 deaths and 4 out of 4 deaths occurred in the 6834 and 10250 mg/kg bw groups during the 14 day observation period, respectively. Deaths occurred within 3 days in all cases.
Clinical signs:
Hypoactivity, ruffed fur, labored breathing, muscular weakness and diuresis were noted throughout the test groups. Labored breathing was not noted in the low dose group, while muscular weakness and diuresis were only observed in the two highest dose groups. The increase in clinical signs was dose-related.
Body weight:
Body weights of male and female animals were comparable throughout the groups at the start and end of the study. No statistical analysis was performed.
Gross pathology:
Necropsy examination of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the surviving animals.
Other findings:
No data available.

Clinical signs

Dose (mg/kg bw) Reaction Time of onset after dose administration Duration of reaction
3038 Hypoactivity 1 hour 1 day
  Ruffed fur 1 hour 1 day
4556 Hypoactivity 1 hour 2 days
  Ruffed fur 1 hour 2 days
  Labored breathing 3 hours 6-22 hours
6834 Hypoactivity 1 hour 5 days
  Ruffed fur 1 hour 5 days
  Labored breathing 2 hours 2 days
  Muscular weakness 3 hours 2 days
  Diuresis 6-22 hours 2 days
10250 Hypoactivity 1 hour Until death
  Ruffed fur 1 hour
  Labored breathing 2 hours
  Muscular weakness 3 hours
  Diuresis 6-22 hours

Body weights

Dose (mg/kg bw) Animal Body weight (grams)  
    Initial Final
3038 1-M 173 274
  2-M 157 258
  3-F 163 215
  4-F 164 220
4556 5-M 163 286
  6-M 168 286
  7-F 171 224
  8-F 190 226
6834 9-M 164 -
  10-M 163 277
  11-F 185 -
  12-F 183 -
10250 13-M 160 -
  14-M 174 -
  15-F 191 -
  16-F 176 -
Interpretation of results:
GHS criteria not met
Conclusions:
In this study the acute oral toxicity potential of Diacid 1550 was tested in rats by administration of doses varying from 3 to 10 g/kg bw by gavage. The acute oral LD50 was established to be 6176 mg/kg bw and therefore, the substance is not considered acute toxic via the oral route and does not have to be classified in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.
Executive summary:

Groups of 4 albino rats (2 male, 2 female) were administered by gavage the test material at doses of approx. 3, 4.5, 7 and 10 g/kg bw (25% w/v Diacid in corn oil). After treatment, the animals were observed for 14 days for clinical signs. Body weights were measured at start and end of the observation period. Necropsy was performed on all animals.

No mortality occurred in the two test groups receiving the lowest doses. 3 out of 4 deaths and 4 out of 4 deaths occurred in the 6834 and 10250 mg/kg bw groups during the 14 day observation period, respectively. Deaths occurred within 3 days in all cases. Hypoactivity, ruffed fur, labored breathing, muscular weakness and diuresis were noted throughout the test groups. Labored breathing was not noted in the low dose group, while muscular weakness and diuresis were only observed in the two highest dose groups. The increase in clinical signs was dose-related. Body weights of male and female animals were comparable throughout the groups at the start and end of the study. No statistical analysis was performed. Necropsy examination of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the surviving animals.

The acute oral LD50 was established to be 6176 mg/kg bw and therefore, the substance is not considered acute toxic via the oral route.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across to study on source substance
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The main assumption for this read across approach is that the source substance fatty acids, tall-oil, reaction product with acrylic acid and the target substance fatty acids, tall-oil, reaction product with acrylic acid, potassium salt have a common organic moiety, the anion of the salt.
In fact, the target substance “fatty acids, tall-oil, reaction product with acrylic acid, potassium salt” is the potassium salt of its parent acid “fatty acids, tall-oil, reaction product with acrylic acid”.
In aqueous media, the target substance rapidly dissociates in its parent acid anion and potassium cation.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The fatty acids, tall-oil, reaction product with acrylic acid (EC 939-424-4) is a UVCB substance in its own right and therefore, of 100 % purity. This substance is neutralized by potassium hydroxide; CAS 1310-58-3; EC 215-181-3; as 45 % aqueous solution.
3. ANALOGUE APPROACH JUSTIFICATION
A reliable acute toxicity study is available for the source substance fatty acids, tall-oil, reaction product with acrylic acid, showing that the substance is not acute toxic via the oral route (LD 50 = 6176 mg/kg).
Since the target and the source substance dissociate to the same anion and potassium (cation) is known to be non-toxic, both, target and read-across substance, do share the same toxicological mechanisms, and the effects of the target substance is predicted to be equal to the effects of the source substance.
The common compound fatty acids, tall-oil, reaction product with acrylic acid is solely responsible for the absence or presence of effects.
The toxicity of potassium cation is assumed to be largely irrelevant in producing any effects to be assessed.
In fact, according to the EFSA opinion of the Scientific Panel on dietetic products, Nutrition and Allergies on a request from the commission related to the Tolerable Upper Intake Level of Potassium, potassium is not classified as acute toxic via the oral route.
Reason / purpose:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of 4 albino rats (2 male, 2 female) were administered the test material by gavage at doses of approx. 3, 4.5, 7 and 10 g/kg bw (25% w/v Diacid in corn oil). After treatment the animals were observed for 14 days for clinical signs. Body weights were measured at start and end of the observation period. Necropsy was performed on all animals.
GLP compliance:
no
Remarks:
test performed prior to GLP
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 176 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
In this study the acute oral toxicity potential of Diacid 1550 was tested in rats by administration of doses varying from 3 to 10 g/kg bw by gavage. The acute oral LD50 was established to be 6176 mg/kg bw and therefore, the substance is not considered acute toxic via the oral route. As the tested substance Diacid 1550 and the traget substance Diacid 1550 potassium salt do share the same organic moity, only distinguishing by the potassium cation, the results form this study is applicable to the potassium salt too.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
6 176 mg/kg bw
Quality of whole database:
The acute oral toxicity potential of Diacid 1550 was tested in rats by administration of doses varying from 3 to 10 g/kg bw by gavage. The acute oral LD50 was established to be 6176 mg/kg bw and therefore the substance is not considered acute toxic via the oral route. As the organic moiety is decisive for toxicity (not the potassium cation), this result is representative for the corresponding potassium salt too.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Endpoint conclusion:
no study available

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:
April -September 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Identification: H-240 100% a.s.
Synonyms: Diacid H-240; OCD 9142-055
CAS Number: 68127-33-3
Purity: 100%
Physical state/Appearance: amber colored solid
Expiry Date: 10 April 2018
Storage Conditions: room temperature in the dark

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Five male and five female Wistar (RccHanTm:WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals weighed at least 200 g, and were 8 to 12 weeks of age. The weight variation did not exceed ±20% of the mean weight for each sex.
The animals were housed in suspended solid floor polypropylene cages furnished with woodflakes. The initial two animals were housed individually throughout the study. The further group of eight animals (four male and four female) were housed individually during the 24-hour exposure period and in groups of four, by sex, for the remainder of the study. Free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study.
The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70%, respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Type of coverage:
semiocclusive
Vehicle:
other: For the purpose of the study the test item was weighed out according to each animal's individual body weight and moistened with distilled water prior to application.
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males (2000 mg/kg), 5 females (2000 mg/kg)
Control animals:
no
Details on study design:
On the day before treatment the back and flanks of each animal were clipped free of hair.
In the absence of data suggesting the test item was toxic, one male and one female rat were initially treated with the test item at a dose level of 2000 mg/kg.
The appropriate amount of test item, moistened with distilled water, was applied as evenly as possible to an area of shorn skin (approximately 10% of the total body surface area). A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. The animals were caged individually throughout the study. Shortly after dosing the dressings were examined to ensure that they were securely in place.
After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test item.
As no mortalities were noted a further group of animals (four males and four females) was similarly treated with the test item at a dose level of 2000 mg/kg body weight to give a total of five males and five females. The animals were caged individually for the 24-hour exposure period. After the 24-hour contact period the bandages were carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test item. These animals were returned to group housing for the remainder of the test period.
The animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
After removal of the dressings and subsequently once daily for 14 days, the test sites were examined for evidence of primary irritation and scored according to the following scale:

EVALUATION OF SKIN REACTIONS

Erythema and Eschar Formation
Value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth) 4

Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) 4

Any other skin reactions, if present were also recorded.
Individual body weights were recorded prior to application of the test item on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Statistics:
The following computerized system was used in the study:
Delta Controls — ORCAview
Preliminary study:
Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg body weight. As no mortalities were noted a further group of animals (four males and four females) was similarly treated with the test item at a dose level of 2000 mg/kg body weight to give a total of five males and five females.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths
Clinical signs:
No signs of systemic toxicity were noted during the observation period
Body weight:
One female showed no gain in body weight during the first week with expected gain in body weight during the second week and one other female showed expected gain in body weight during the first week but body weight loss during the second week. The remaining animals showed expected gains in body weight over the study period.
Gross pathology:
No abnormalities were noted at necropsy
Other findings:
Dermal reactions: Very slight or well-defined erythema and very slight or slight edema were noted at the test sites of all animals. Hemorrhage of dermal capillaries and/or small superficial scattered scabs were noted at the test sites of three animals. Scab cracking was also noted at the test site of one male. Loss of skin elasticity and flexibility was noted at the test sites of two males.

Individual clinical observations and mortality data

Dose
Level
mg/lig

Animal
Number
and Sex

Effects Noted After Dosing
(Hours)

Effects Noted During Period After Dosing

(Days)

Y2

 1

2

4

1

2

3

4

5

6

7

8

9

10

11

12

13

14

2000

1-0
Male

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3-0
Male

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3-1
Male

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3-2
Male

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3-3
Male

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2-0
Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4-0
Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4-1
Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4-2
Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4-3
Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0 = No signs of systemic toxicity

Individual Dermal Reactions - Males

Dose Level mg/kg

Animal
Number
and Sex

Observation

Effects Noted After Initiation of Exposure (Days)

1

2

3

4

5

6

7

8

9

10

11

12

13

14

2000

1-0
Male

Erythema

2

1

1

0

0

0

0

0

0

0

0

0

0

0

Edema

2

1

0

0

0

0

0

0

0

0

0

0

0

0

Other

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3-0
Male

Erythema

2

2

2

0

0

0

0

0

0

0

0

0

0

0

Edema

2

2

2

0

0

0

0

0

0

0

0

0

0

0

Other

0

Hd

Ss

Ss

0

0

0

0

0

0

0

0

0

0

3-1
Male

Erythema

2

1

0

0

0

0

0

0

0

0

0

0

0

0

Edema

2

1

0

0

0

0

0

0

0

0

0

0

0

0

Other

0

0

LeLf

0

0

0

0

0

0

0

0

0

0

0

3-2
Male

Erythema

2

2

2

0

0

0

0

0

0

0

0

0

0

0

Edema

2

2

2

0

0

0

0

0

0

0

0

0

0

0

Other

0

0

Ss

SsSk

Ss

Ss

Ss

Ss

Ss

0

0

0

0

0

3-3
Male

Erythema

2

1

0

0

0

0

0

0

0

0

0

0

0

0

Edema

2

1

0

0

0

0

0

0

0

0

0

0

0

0

Other

0

0

LeLf

0

0

0

0

0

0

0

0

0

0

0

0 = No reactions

Hd = Hemorrhage of dermal capillaries

Ss = Small superficial scattered scabs         

0 = Due to a technician error observation not recorded

Individual Dermal Reactions - Females

Dose Level mg/kg

Animal
Number
and Sex

Observation

Effects Noted After Initiation of Exposure (Days)

1

2

3

4

5

6

7

8

9

10

11

12

13

14

2000

2-0
Female

Erythema

1

0

0

0

0

0

0

0

0

0

0

0

0

0

Edema

1

0

0

0

0

0

0

0

0

0

0

0

0

0

Other

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4-0
Female

Erythema

2

2

1

0

0

0

0

0

0

0

0

0

0

0

Edema

2

2

1

0

0

0

0

0

0

0

0

0

0

0

Other

0

Hd

Ss

Ss

Ss

Ss

Ss

Ss

Ss

0

0

0

0

0

4-1
Female

Erythema

2

1

1

0

0

0

0

0

0

0

0

0

0

0

Edema

2

1

0

0

0

0

0

0

0

0

0

0

0

0

Other

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4-2
Female

Erythema

2

1

0

0

0

0

0

0

0

0

0

0

0

0

Edema

1

1

0

0

0

0

0

0

0

0

0

0

0

0

Other

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4-3
Female

Erythema

2

2

1

0

0

0

0

0

0

0

0

0

0

0

Edema

2

1

0

0

0

0

0

0

0

0

0

0

0

0

Other

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0 = No reactions

Hd = Hemorrhage of dermal capillaries

Ss = Small superficial scattered scabs         

0 = Due to a technician error observation not recorded

Individual Body Weights and Body Weight Changes

Dose Level
mg/kg

Animal Number
and Sex

Body Weight (g) at Day

Body Weight Change (g) During Week

0

7

14

1

2

2000

1-0 Male

260

282

319

22

37

3-0 Male

287

306

326

19

20

3-1 Male

281

303

320

22

17

3-2 Male

284

305

328

21

23

3-3 Male

269

284

302

15

18

2-0 Female

222

250

245

28

—5

4-0 Female

234

235

247

1

12

4-1 Female

228

228

238

0

10

4-2 Female

230

241

257

11

16

4-3 Female

225

230

241

5

11

Individual Necropsy Findings

Dose Level
mg/kg

Animal Number
and Sex

Time of Death

Macroscopic Observations

2000

1-0
Male

Killed Day 14

No abnormalities detected

3-0
Male

Killed Day 14

No abnormalities detected

3-1
Male

Killed Day 14

No abnormalities detected

3-2
Male

Killed Day 14

No abnormalities detected

3-3
Male

Killed Day 14

No abnormalities detected

2-0
Female

Killed Day 14

No abnormalities detected

4-0
Female

Killed Day 14

No abnormalities detected

4-1
Female

Killed Day 14

No abnormalities detected

4-2
Female

Killed Day 14

No abnormalities detected

4-3
Female

Killed Day 14

No abnormalities detected

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
Executive summary:

The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat.

Methods

Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg body weight. Based on the results of the initial test, a further group of eight animals (four males and four females) was equally treated. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity.

Dermal Irritation. Signs of dermal irritation noted were very slight to well-defined erythema, very slight to slight edema, hemorrhage of dermal capillaries, loss of skin elasticity and flexibility, small superficial scattered scabs and scab cracking.

Body Weight. One female showed no gain in body weight during the first week with expected gain in body weight during the second week and one other female showed expected gain in body weight during the first week but body weight loss during the second week. The remaining animals showed expected gains in body weight over the study period.

Necropsy. No abnormalities were noted at necropsy.


Conclusion

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight. Dermal irritation was low and below threshold for classification. Furthermore, all dermal irritation scores reduced over time, showing the effects being fully reversible.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.

Justification for classification or non-classification

Based on acute oral and dermal toxicity test results, the substance was shown not to be subject to classification according to CLP (Regulation EC No. 1272/2008).