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EC number: 606-467-2 | CAS number: 202189-76-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Acute toxicity: oral.
Key study: According to OECD guideline 423 and test method B1. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 28, 2002 - June 11, 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: sponsor
- Batch No.of test material: F-24 Reprec.
- Purity test date: May 22, 2002
- Purity: 96.8%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored at room temperature, protected from moisture and in the absence of light. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3-4 weeks old
- Weight at study initiation: 72.7 - 77.4 g (males); 72.6 - 79.9 g (females)
- Housing: The animals were house in Makrolon type III cages (930 cm2 surface) with a stainless steel mesh lid and a poplar sawdust bedding, at the rate of 3 animals per cage. The sawdust and the tray were changed three times a week. The mesh lid and the feeding bottle were changed once a week
- Diet: ad linitum, foodstuff UAR-R04-C (Panlab, S.L., Barcelona. Batch 10517. Expiration date: May 17, 2003) on a controlled maintenance diet.
- Water: ad libitum, tap-water from public distribution system (Consorcio de Aguas Bilbao Bizkaia) ad libitum. During the study, the physical and chemical properties of the water were analyzed twice, obtaining satisfactory results.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22ºC (+/- 3ºC)
- Humidity: 30-70%
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
- Microbiological controls on the air and the surface of the room have been carried out resulting in 54 UFC/m3 in air, 0 UFC/plate on the wall and 7 UFC/plate in soil.
IN-LIFE DATES: From: May 28, 2002 To: June 11, 2002 - Route of administration:
- oral: gavage
- Vehicle:
- other: Xanthan gum suspended 25% (w/v) in tap water
- Remarks:
- Xhantan gum supplied by the sponsor's Raw Materials Warehouse
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 8.84 g
- Lot/batch no.: L0992
MAXIMUM DOSE VOLUME APPLIED: 1 mL/100g bw
DOSAGE PREPARATION: 8.84 g of vehicle were progressively added to 2.066 g of the test item. Test item was suspended by magnetic stirring in the vehicle. Gross particles were grounded using a metal spatula to improve test item dispersion.
- Doses:
- 2000mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At 1h, 2h, 3h, 5h, then, observations were done at least once a day for 14 days. Animals were weighed on days 1, 2, 3, 7, 9, 11 and 14.
- Necropsy of survivors performed: yes. On D14 after the administration, each animal was sacrificed and the necropsy was performed. It was examined the organs and tissues of the cranial cavity, thoracic and abdominal cavity, taking special care on each organ after extraction.
- Other examinations performed:
Mortality: animals were observed daily in order to register mortality
Clinical signs: In order to register the beginning and evolution of the possible toxic effects of the test item, animals were observed during the following 5 hours after administration, (0h, 1h,2h, 3h, 5h), then, observations were done at least once a day for 14 days. Parameters observed on animals inside the cage: physical activity, posture while walking, posture at rest and sense of fear. Parameters observed on each animal outside the cage: nervousness/agitation, fear, tremors; hair, eyes, nostrils and stools appearance; posture while walking and posture at rest.
Body weight: Body weight was assed in day 1,2,3,7,9, 11 and 14. The mean body weight has been calculated based on the individual body weights recorded in each weighing.
Body temperature: the body temperature was assessed with a temperature probe that was introduced approximately 2-3 cm into the rectum of every animal in a total of a 6 times during the test.
Locomotor activity: The locomotor activity has been assessed based on the number of frames traversed by each animal for 2 minutes. The test was performed in a total of 9 times during the test.
Hematology: At the end of the test, before necropsy, blood samples were obtained from the jugular veins of all surviving animals, after anesthesia by inhalation of ethyl ether. The fasting period before blood drawn was of 19-20 hours (animals were not deprived of drinking water). The parameters examined were red blood cells count (RBCs), white blood cells count (WBCs), hemoglobine (HB), hematocrit (HCT), mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), platelet count (PLT).
Food intake: observations were done on day 2, 3, 6, 11 and 14. - Preliminary study:
- A preliminary study was performed by administration of a single dose of 1000 mg/kg in mouse. No mortality occurred during the study. Therefore, the dose determined for the main study was 2000 mg/kg.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs observed during the study, with the exception of tha animal AH3 that presented, after 2 hours of the administration, a remarkable nervousness/agitation and alteration of the body posture (dorsal bending and pelvic elevation) and that was
- Gross pathology:
- No macroscopic lesions were found that could be attributed to a toxic effect of the test item.
- Other findings:
- Feed intake: In both males and females, there was a slight decrease in feed intake during the 24 hours after administration, about 10%, which in females recovered after 48 hours and in males the recovery occurred progressively until day 5 of the study.
Hematology: A slight increase in the number of platelets (10-12%) was observed in both males and females - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.
- Executive summary:
An acute toxic class method test on rats was performed according to OECD Guideline 423 and test method B.1. The test item was administered, as supplied, to a group of 6 male and female Wistar rats (3-4 weeks old, 3 per group) at the dose of 2000 mg/kg body weight by oral gavage. The selection of the dose was made based on the preliminary results obtained, in which the administration of a dose of 1000 mg / kg in mouse did not cause the death of any of the animals administered with the test item.
No clinical signs observed during the study, with the exception of the female AH3 that presented a remarkable nervousness/agitation and alteration of the body posture (dorsal bending and pelvic elevation) and that was maintained until the animal was euthanized. Hematological analysis revealed mild thrombocytosis in both males and females. Necropsies and macroscopic study of organs and tissues have not revealed the presence of macroscopic alterations attributable to a toxic effect of the test item. No mortality occurred during the study, therefore the LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.
Reference
Body temperature (ºC) – Males
|
Time after administration |
|||||
Animal |
5-6 hours |
24 hours |
48 hours |
Day 7 |
Day 9 |
Day 14 |
TM1 |
35.9 |
37.2 |
36.5 |
37.8 |
37.3 |
37.5 |
TM2 |
36.4 |
37.0 |
36.9 |
37.7 |
38.0 |
37.7 |
TM3 |
36.0 |
37.3 |
36.6 |
37.7 |
38.1 |
38.4 |
Group T: Mean temperature |
36.1 |
37.2 |
36.7 |
37.7 |
37.8 |
37.9 |
AM1 |
35.8 |
37.4 |
37.1 |
37.8 |
37.6 |
37.9 |
AM2 |
36.1 |
37.3 |
37.0 |
37.1 |
37.7 |
38.1 |
AM3 |
35.5 |
37.0 |
36.9 |
37.1 |
37.7 |
38.1 |
Group A: Mean temperature |
35.8 |
37.2 |
37.0 |
37.3 |
37.7 |
38.0 |
|
|
|
|
|
|
|
Difference A - T (%) |
- 0.8 |
0 |
+ 0.8 |
- 1.1 |
- 0.3 |
+ 0.3 |
(T) = group T; dose (mg/kg): 0
(A) = group A; dose (mg/kg): 2000
Body temperature (ºC) – Females
|
Time after administration |
|||||
Animal |
5-6 hours |
24 hours |
48 hours |
Day 7 |
Day 9 |
Day 14 |
TH1 |
36.7 |
37.1 |
37.7 |
37.3 |
38.1 |
38.2 |
TH2 |
37.1 |
37.4 |
38.1 |
38.2 |
38.1 |
38.7 |
TH3 |
36.7 |
37.1 |
38.0 |
37.7 |
37.7 |
38.3 |
Group T: Mean temperature |
36.8 |
37.2 |
37.9 |
37.7 |
38.0 |
38.4 |
AH1 |
36.5 |
37.7 |
37.6 |
37.8 |
37.7 |
38.7 |
AH2 |
36.2 |
37.5 |
38.1 |
37.5 |
37.8 |
38.5 |
AH3 |
36.7 |
37.4 |
38.2 |
37.6 |
38.3 |
38.4 |
Group A: Mean temperature |
36.5 |
37.5 |
38.0 |
37.6 |
37.9 |
38.5 |
|
|
|
|
|
|
|
Difference A - T (%) |
- 0.8 |
+ 0.8 |
+ 0.3 |
- 0.3 |
- 0.3 |
+ 0.3 |
(T) = group T; dose (mg/kg): 0
(A) = group A; dose (mg/kg): 2000
Locomotor activity (No. of frames traversed in 2 minutes) – Males
|
Time after administration |
||||||||
Animal |
5-6 hours |
24 hours |
30 hours |
48 hours |
3 days |
7 days |
9 days |
11 days |
14 days |
TM1 |
2 |
6 |
17 |
5 |
12 |
22 |
3 |
7 |
2 |
TM2 |
3 |
5 |
26 |
6 |
16 |
3 |
14 |
5 |
9 |
TM3 |
3 |
18 |
2 |
12 |
41 |
39 |
52 |
41 |
25 |
Group T: Mean activity |
2.7 |
9.7 |
15.0 |
7.7 |
23.0 |
21.3 |
23.0 |
17.7 |
12.0 |
AM1 |
3 |
28 |
20 |
29 |
41 |
45 |
26 |
25 |
35 |
AM2 |
11 |
28 |
26 |
13 |
19 |
16 |
22 |
18 |
19 |
AM3 |
2 |
9 |
8 |
4 |
22 |
7 |
44 |
39 |
39 |
Group A: Mean activity |
5.3 |
21.7 |
18.0 |
15.3 |
27.3 |
22.7 |
30.7 |
27.3 |
31.0 |
(T) = group T; dose (mg/kg): 0
(A) = group A; dose (mg/kg): 2000
Locomotor activity (No. of frames traversed in 2 minutes) – Females
|
Time after administration |
||||||||
Animal |
5-6 hours |
24 hours |
30 hours |
48 hours |
3 days |
7 days |
9 days |
11 days |
14 days |
TH1 |
4 |
3 |
16 |
3 |
6 |
17 |
30 |
55 |
66 |
TH2 |
14 |
13 |
2 |
17 |
19 |
32 |
33 |
26 |
32 |
TH3 |
1 |
5 |
41 |
31 |
21 |
37 |
13 |
41 |
43 |
Group T: Mean activity |
6.3 |
7.0 |
19.7 |
17.0 |
15.3 |
28.7 |
25.3 |
40.7 |
47.0 |
AH1 |
3 |
10 |
17 |
1 |
36 |
44 |
30 |
50 |
64 |
AH2 |
2 |
14 |
23 |
3 |
2 |
28 |
6 |
23 |
54 |
AH3 |
3 |
28 |
37 |
17 |
42 |
46 |
52 |
67 |
57 |
Group A: Mean activity |
2.7 |
17.3 |
25.7 |
7.0 |
26.7 |
39.3 |
29.3 |
46.7 |
58.3 |
(T) = group T; dose (mg/kg): 0
(A) = group A; dose (mg/kg): 2000
Individual weight (g) – Males
|
Day of the study |
||||||
Animal |
1 |
2 |
3 |
7 |
9 |
11 |
14 |
TM1 |
74.5 |
85.2 |
90.9 |
120.1 |
134.4 |
147.1 |
170.8 |
TM2 |
77.4 |
91.2 |
98.7 |
133.0 |
154.3 |
174.0 |
200.6 |
TM3 |
76.7 |
87.5 |
97.7 |
129.1 |
144.4 |
158.1 |
181.0 |
Group T: Mean weight |
76.20 |
87.97 |
95.77 |
127.40 |
144.37 |
159.73 |
184.13 |
AM1 |
72.7 |
83.3 |
89.7 |
123.2 |
144.6 |
163.7 |
191.0 |
AM2 |
76.4 |
91.7 |
96.8 |
129.4 |
144.1 |
166.2 |
192.8 |
AM3 |
74.6 |
85.1 |
93.7 |
120.1 |
134.9 |
149.5 |
165.6 |
Group A: Mean weight |
74.57 |
86.70 |
93.40 |
124.23 |
141.20 |
159.80 |
183.13 |
(T) = group T; dose (mg/kg): 0
(A) = group A; dose (mg/kg): 2000
Individual weight (g) – Females
|
Day of the study |
||||||
Animal |
1 |
2 |
3 |
7 |
9 |
11 |
14 |
TH1 |
75.6 |
87.6 |
94.2 |
119.8 |
127.1 |
136.0 |
146.8 |
TH2 |
72.6 |
85.4 |
91.6 |
116.7 |
126.9 |
135.4 |
151.0 |
TH3 |
73.7 |
83.8 |
89.1 |
113.0 |
123.8 |
131.5 |
144.3 |
Group T: Mean weight |
73.97 |
85.60 |
91.63 |
116.50 |
125.93 |
134.30 |
147.37 |
AH1 |
79.9 |
87.3 |
92.3 |
120.1 |
134.2 |
141.1 |
159.9 |
AH2 |
74.2 |
85.7 |
92.8 |
119.3 |
129.0 |
140.8 |
149.9 |
AH3 |
75.0 |
82.7 |
89.0 |
114.4 |
121.6 |
129.0 |
141.7 |
Group A: Mean weight |
76.37 |
85.23 |
91.37 |
116.93 |
128.27 |
136.97 |
150.50 |
(T) = group T; dose (mg/kg): 0
(A) = group A; dose (mg/kg): 2000
Evolution (Statistical analysis) – Males
|
Day of the study |
||||||||||||||
1 |
2 |
3 |
7 |
9 |
11 |
14 |
|
||||||||
T |
A |
T |
A |
T |
A |
T |
A |
T |
A |
T |
A |
T |
A |
|
|
Mean weight (g) |
76.20 |
74.57 |
87.97 |
86.70 |
95.77 |
93.40 |
127.40 |
124.23 |
144.37 |
141.20 |
159.73 |
159.80 |
184.13 |
183.13 |
|
Difference with respect to T |
- |
- 2.14 |
- |
- 1.44 |
- |
- 2.47 |
- |
- 2.49 |
- |
- 2.20 |
- |
+ 0.04 |
- |
- 0.54 |
|
DE |
1.51 |
1.85 |
3.03 |
4.42 |
4.24 |
3.56 |
6.62 |
4.74 |
9.95 |
5.46 |
13.52 |
9.01 |
15.15 |
15.21 |
|
N |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
|
CV (%) |
2 |
2 |
3 |
5 |
4 |
4 |
5 |
4 |
7 |
4 |
8 |
6 |
8 |
8 |
|
P(1)value with respect to group T |
- |
0.4 |
- |
0.7 |
- |
1.0 |
- |
1.0 |
- |
1.0 |
- |
1.0 |
- |
1.0 |
|
(T) = group T; dose (mg/kg): 0
(A) = group A; dose (mg/kg): 2000
(1): Probability by comparing group T and A by the 2-tailed Mann-Whitney U test, with a confidence interval of 95%
Evolution (Statistical analysis) – Females
|
Day of the study |
||||||||||||||
1 |
2 |
3 |
7 |
9 |
11 |
14 |
|
||||||||
T |
A |
T |
A |
T |
A |
T |
A |
T |
A |
T |
A |
T |
A |
|
|
Mean weight (g) |
73.97 |
76.37 |
85.60 |
85.23 |
91.63 |
91.37 |
116.50 |
116.93 |
125.93 |
128.27 |
134.30 |
136.97 |
147.37 |
150.50 |
|
Difference with respect to T |
- |
+ 3.14 |
- |
- 0.43 |
- |
- 0.28 |
- |
+ 0.38 |
- |
+ 1.82 |
- |
+ 1.95 |
- |
+ 2.08 |
|
DE |
1.52 |
3.09 |
1.91 |
2.34 |
2.55 |
2.06 |
3.40 |
4.81 |
1.85 |
6.33 |
2.44 |
6.90 |
3.39 |
9.11 |
|
N |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
|
CV (%) |
2 |
4 |
2 |
3 |
3 |
2 |
3 |
4 |
1 |
5 |
2 |
5 |
2 |
6 |
|
P(1)value with respect to group T |
- |
0.4 |
- |
1.0 |
- |
1.0 |
- |
1.0 |
- |
0.7 |
- |
0.7 |
- |
1.0 |
|
(T) = group T; dose (mg/kg): 0
(A) = group A; dose (mg/kg): 2000
(1): Probability by comparing group T and A by the 2-tailed Mann-Whitney U test, with a confidence interval of 95%
Feed intake (g) – Males and Females
|
Day of the study |
|||||
Animal |
2 |
3 |
7 |
11 |
14 |
|
MALES |
Mean intake Group T |
15.33 |
16.17 |
18.98 |
22.31 |
22.74 |
Mean intake Group A |
13.83 |
15.43 |
18.45 |
23.03 |
23.46 |
|
Difference from A to T (%) |
- 9.78 |
- 4.54 |
- 2.81 |
+ 3.11 |
+ 3.03 |
|
FEMALES |
Mean intake Group T |
16.70 |
14.60 |
15.97 |
17.34 |
15.87 |
Mean intake Group A |
15.07 |
15.73 |
16.98 |
19.14 |
17.94 |
|
Difference from A to T (%) |
- 9.78 |
+ 7.20 |
+ 5.99 |
+ 9.40 |
+ 11.58 |
(T) = group T; dose (mg/kg): 0
(A) = group A; dose (mg/kg): 2000
Hematology – Males
|
Parameter |
|||||||
Animal |
GB (103/ml) |
GR (106/ml) |
HGB (g/dL) |
HCTO (%) |
VCM (fL) |
HCM (pg) |
CHCM (g/dL) |
PLT (103/ml) |
TM1 |
7.2 |
6.00 |
11.8 |
37.7 |
62.9 |
19.7 |
31.3 |
1046.5 |
TM2 |
5.2 |
5.85 |
11.3 |
36.4 |
62.2 |
19.3 |
31.0 |
978.5 |
TM3 |
8.3 |
5.98 |
12.2 |
38.2 |
63.9 |
20.3 |
31.8 |
926.5 |
Group T: Mean value |
6.9 |
5.94 |
11.7 |
37.4 |
63.0 |
19.8 |
31.4 |
983.8 |
AM1 |
6.9 |
6.11 |
11.9 |
37.3 |
61.1 |
19.4 |
31.8 |
1047 |
AM2 |
8.3 |
6.21 |
12.4 |
39.7 |
63.9 |
19.9 |
31.2 |
392.5 |
AM3 |
6.7 |
6.39 |
12.5 |
40.2 |
62.9 |
19.6 |
31.1 |
1158 |
Group A: Mean value |
6.8 |
6.25 |
12.2 |
38.7 |
62.0 |
19.5 |
31.4 |
1102.5 |
Difference from A to T (%) |
- 1.4 |
+ 5.0 |
+ 4.1 |
+ 3.4 |
- 1.6 |
- 1.5 |
0 |
+ 10.8 |
(T) = group T; dose (mg/kg): 0
(A) = group A; dose (mg/kg): 2000
Hematology – Females
|
Parameter |
|||||||
Animal |
GB (103/ml) |
GR (106/ml) |
HGB (g/dL) |
HCTO (%) |
VCM (fL) |
HCM (pg) |
CHCM (g/dL) |
PLT (103/ml) |
TH1 |
6.2 |
6.55 |
12.4 |
38.9 |
59.4 |
19.0 |
31.9 |
987.0 |
TH2 |
5.3 |
6.35 |
12.6 |
39.6 |
62.3 |
19.8 |
31.7 |
1008.0 |
TH3 |
6.5 |
6.08 |
12.2 |
38.3 |
63.0 |
20.0 |
31.8 |
957.5 |
Group T: Mean value |
6.0 |
6.32 |
12.4 |
38.9 |
61.5 |
19.6 |
31.8 |
948.2 |
AH1 |
6.4 |
6.71 |
12.8 |
41.1 |
61.3 |
19.1 |
31.2 |
1132.0 |
AH2 |
6.4 |
6.23 |
12.6 |
38.2 |
61.3 |
20.3 |
33.0 |
1110.5 |
AH3 |
4.0 |
6.12 |
12.9 |
40.0 |
65.4 |
21.1 |
32.3 |
1142.5 |
Group A: Mean value |
6.4 |
6.47 |
12.7 |
39.6 |
61.3 |
19.7 |
32.1 |
1121.3 |
Difference from A to T (%) |
+ 6.3 |
+ 2.3 |
+ 2.4 |
+ 1.8 |
- 0.3 |
+ 0.5 |
+ 0.9 |
+ 12.2 |
(T) = group T; dose (mg/kg): 0
(A) = group A; dose (mg/kg): 2000
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch 2. No GLP study.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: oral
Key study: According to OECD guideline 423 and test method B1. An acute toxic class method test on Wistar rats was performed at the dose of 2000 mg/kg body weight by oral gavage. No clinical signs were observed during the study, with the exception of one female that presented a remarkable nervousness/agitation and alteration of the body posture and that was maintained until the animal was euthanized. Hematological analysis revealed mild thrombocytosis in both males and females. Necropsies and macroscopic study of organs and tissues have not revealed the presence of macroscopic alterations attributable to a toxic effect of the test item. No mortality occurred during the study, therefore the LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.
Justification for classification or non-classification
Based on the available data, the substance is not classified for acute oral toxicity (LD50 > 2000 mg/kg bw) according to CLP Regulation no. 1272/2008.
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