Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 cut-off (female) = 2500 mg/ kg bw

Acute dermal toxicity: LD50 >2000 mg/kg bw

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:
26 June 2018 - 14 Aug 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SUQIAN UNITECH CO., LTD; 2018041002
- Purity: 99.29%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was weighed out into a tared plastic vial on a precision balance and finely ground with the help of a mortar and pestle. The test item was then suspended with the vehicle corn oil to gain a final volume of 10 mL and to achieve a dose of 2000mg/kg body weight at a dose volume of 10 mL/kg body weight. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before each dose administration.
Species:
rat
Strain:
other: WISTAR Crl: WI(Han)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 8–10 weeks
- Weight at study initiation: Step 1: 173–181 g;Step 2: 178–183 g
- Fasting period before study: 16 to 19 hours
- Housing: Full barrier in an air-conditioned room
- Diet: Free access to Altromin 1324 maintenance diet for rats and mice
- Water: Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water,municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
Route of administration:
oral: gavage
Vehicle:
other: corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The test item does not make a solution or suspension with water, so the corn oil has to be used.
- Lot/batch no. (if required): MKCD1821

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose level of 2000 mg/kg bw was used as the starting dose, according to the test guideline, No compound-related mortality was recorded for any other animals of step 1 or 2.
Doses:
Steps 1 & 2: 2000 mg/kg body weight
No. of animals per sex per dose:
3 per step
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy.
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
2 500 mg/kg bw
Mortality:
For one animal (-Step 1, Animal No.1) compound-related mortality occurred. No compound-related mortality was recorded for any other animals of step 1 or 2.
Clinical signs:
The most relevant clinical findings were reduced spontaneous activity, hunched posture, piloerection, eyes half closed, diarrhoea and slight weight loss during the first study week. All animals recovered within up to 8 days post-dose (Table 1).
Body weight:
One day after test item administration a slight weight loss was observed in 5 out of 6 animals. By the end of the first week, 1 of 5 surviving animals still showed a slight weight loss. All of the surviving animals showed an overall weight gain during the 14-day study period (for individual data see Table 2).
Gross pathology:
Detailed pathological findings of the study are presented in Table 3.
No specific gross pathological changes were recorded for any animal.

Table 1: Clinical Signs - Individual Data

Step Animal No. / Sex Starting Dose (mg/kg bw) Time Point  Observations

1

1 / Female 2000 0 min – 30 min nsf
30 min – 120 min Hunched posture,
slight piloerection
120 min – d 2 Slightly reduced spontaneous activity, hunched posture, moderate piloerection, moderate diarrhoea
d 2 Slightly reduced spontaneous activity, hunched posture, moderate piloerection, slight diarrhoea,
slight weight loss (2%)
d 3 found dead
2 / Female 2000 0 min – 30 min nsf
30 min – 120 min Hunched posture,
slight piloerection
120 min – d 2 Slightly reduced spontaneous activity, hunched posture, moderate piloerection, moderate diarrhoea
d 2 – d 3 Slightly reduced spontaneous activity, hunched posture, moderate piloerection, moderate diarrhoea, slight weight loss
(3% by d 3)
d 4 Moderately reduced spontaneous activity, hunched posture, moderate piloerection
d 5 – d 8 Slight piloerection
d 9 – d 15 nsf
3 / Female 2000 0 min – 30 min nsf
30 min – 120 min Hunched posture,
slight piloerection
120 min – d 2 Slightly reduced spontaneous activity, hunched posture, moderate piloerection, diarrhoea moderate
d 2 Slightly reduced spontaneous activity, hunched posture, moderate piloerection, moderate diarrhoea, slight weight loss (<1%)
d 3 Slightly reduced spontaneous activity, hunched posture, moderate piloerection, slight diarrhoea
d 4 Moderately reduced spontaneous activity, hunched posture,
moderate piloerection
d 5 Slight piloerection
d 6 Moderate piloerection
d 7 – d 8 Slight piloerection
d 9 – d 15 nsf

2

4 / Female 2000 0 min – 30 min nsf
30 min – 60 min Slight piloerection
60 min – 120 min Slightly reduced spontaneous activity, hunched posture,
slight piloerection
120 min – 180 min Slightly reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid-closure, moderate diarrhoea
180 min – 240 min Spontaneous activity moderately reduced, hunched posture, moderate piloerection,
moderate diarrhoea
240 min – d 2 Spontaneous activity moderately reduced, hunched posture, moderate piloerection, half eyelid-closure, moderate diarrhoea
d 2 Slight piloerection, severe diarrhoea, slight weight loss (1%)
d 3 Slight diarrhoea
d 4 – d 15 nsf
5 / Female 2000 0 min – 30 min nsf
30 min – 60 min Slight piloerection
60 min – 120 min Slightly reduced spontaneous activity, hunched posture,
slight piloerection
120 min – 180 min Slightly reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid-closure, moderate diarrhoea
180 min – 240 min Moderately reduced spontaneous activity, hunched posture, moderate piloerection,
moderate diarrhoea
240 min – d 2 Moderately reduced spontaneous activity, hunched posture, severe piloerection, half eyelid-closure, moderate diarrhoea
d 2 Slight piloerection, severe diarrhoea, slight weight loss (7%)
d 3 Slight diarrhoea
d 4 – d 15 nsf
6 / Female 2000 0 min – 30 min nsf
30 min – 60 min Slight piloerection
60 min – 120 min Spontaneous activity slightly reduced, hunched posture,
slight piloerection
120 min – 180 min Slightly reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid-closure, diarrhoea moderate
180 min – 240 min Moderately reduced spontaneous activity, hunched posture, moderate piloerection,
moderate diarrhoea
240 min – d 2 Moderately reduced spontaneous activity, hunched posture, moderate piloerection, half eyelid-closure, moderate diarrhoea
d 2 Slight piloerection,
severe diarrhoea
d 3 Slight diarrhoea
d 4 – d 15 nsf

bw = body weight; d = day (day 1 = day of administration); min = minute(s); nsf = no specific findings

Table 2:Absolute Body Weights in g and Body Weight Change in %

Step Animal No. / Sex Starting Dose (mg/kg bw) BW (g) Body Weight Change in Comparison to Day 1 (%)
Day 1 Day 8 Day 15 Day 15
1 1 / Female 2000 181 Found dead on study day 3
2 / Female 2000 175 194 225 29
3 / Female 2000 173 205 208 20
2 4 / Female 2000 183 196 203 11
5 / Female 2000 179 177 197 10
6 / Female 2000 178 184 210 18

bw= body weight

Table 3:Findings of the Necropsy - Individual Data

Step Animal No. / Sex Starting Dose (mg/kg bw) Organ Macroscopic Findings
1 1 / Female 2000  -  nsf
2 / Female  -  nsf
3 / Female  -  nsf
2 4 / Female  -  nsf
5 / Female  -  nsf
6 / Female  -  nsf

bw = body weight;nsf = no specific findings

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Not classified according to CLP
Conclusions:
The median lethal dose of 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 2500 mg/ kg bw
Executive summary:

In an acute oral toxicity test (183811), 2 groups of female Wistar Crl: WI(Han) rats (3/group) were administered 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine (99.29%) in corn oil by oral gavage at a dose of 2000 mg/kg bw.

The LD50 (cut-off) was 2500 mg/kg bw.

One animal of step 1 was found dead 2 days post-application. All remaining animals survived until the end of the study showing signs of toxicity. The most relevant clinical findings were reduced spontaneous activity, hunched posture, piloerection, eyes half closed, diarrhoea and slight weight loss during the first study week. All animals recovered within up to 8 days post-dose. Throughout the 14-day observation period, the weight gain of the surviving animals was within the normal range of variation for this strain. At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 500 mg/kg bw
Quality of whole database:
There is one key study available for acute oral toxicity and it is an OECD guideline/GLP study. The quality of the database is high.

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
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Because of the non-uniform particle size of the sample, we selected some samples for particle size analysis, and the particle diameter greater than 2000 microns does not take into account the particle size distribution results. Finally, the results show that the particle size less than 100 um does not exceed 10%.
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:
13 August 2018 - 03 December 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
OECD Guidelines for Testing of Chemicals, Section 4, No. 402, “Acute Dermal Toxicity” adopted 09
Oct, 2017
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SUQIAN UNITECH CO., LTD; 2018041002
- Purity: 99.29%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: On sponsor’s request the dose was calculated based on the purity of the active component and a correction factor of 1.01 was applied.

Species:
rat
Strain:
other: WISTAR Crl: WI(Han)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 7–10 weeks
- Weight at study initiation: 201–220 g
- Diet: Free access to Altromin 1324 maintenance diet for rats and mice
- Water: Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: controlled full-barrier maintained breeding system (SPF)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
aqua ad injectionem (sterile water)
Details on dermal exposure:
The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface. Approximately 24 hours before the test, the fur was removed from the dorsal area of the trunk using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used. The test item was held in contact with the skin by a dressing throughout a 24-hour period. This consisted of a semi-occlusive dressing made of a porous gauze and non-irritating tape and was fixed with an additional dressing in a suitable manner. At the end of the exposure period the residual test item was removed using aqua ad injectionem (sterile water).
Duration of exposure:
24 hrs
Doses:
Dose range finding : 2000 mg/kg bw.
Main test: 2000 mg/kg bw
No. of animals per sex per dose:
DRF: 1 female
Main test: 2 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation during the whole observation period. The animals were weighed on day 1 (prior to the application), on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Signs of erythema and oedema were assessed using the scoring system laid down in OECD Guideline 404 24, 48 and 72 hours after patch removal.
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 6 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.
Preliminary study:
The test item showed neither mortality nor signs of acute dermal toxicity but signs of dermal irritation after a single dose application (erythema grade 1, oedema grade 1 and desquamation. All signs of irritation were reversible within up to day 10.). A slight weight loss was recorded during the first week, but the animal showed weight gain during the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded. The abdominal region had a yellow solid mass upon necropsy. (Tables 2,4 6,7). The dose of 2000 mg/kg bw was used in the main study.
Key result
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
> 2 000 - <= 5 000 mg/kg bw
Mortality:
The test item showed neither mortality nor signs of acute dermal toxicity.
Clinical signs:
No signs of toxicity were observed througout the entire observation period (Table 3).

Erythema grade 2 in animal no. 2 (main study) and grade 1 in animal no. 3 (main study) was observed. Besides erythema, animal no. 2 (main study) showed oedema grade 1 and desquamation and animal no. 3 (main study) showed scratches. All signs of irritation were reversible within up to day 10. (Table 5)
Body weight:
A slight weight loss was recorded for 1 out of 2 female animals during the first week, but all of the female animals showed weight gain during the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded (Table 6).
Gross pathology:
No specific gross pathological changes were recorded for any other animal in the main study (Table 7).

Table 2:  Clinical Signs of Systemic Toxicity - Individual Data – Dose Range Finding Study

Animal
No. / Sex / Dose

Time of Observation

Observation

1 / female /
2000 mg/kg bw

during the whole observation period

no signs of toxicity

bw = body weight

Table 3:  Clinical Signs of Systemic Toxicity - Individual Data – Main Study

Animal
No. / Sex / Dose

Time of Observation

Observations

2 / female /
2000 mg/kg bw

during the whole observation period

no signs of toxicity

3 / female /
2000 mg/kg bw

during the whole observation period

no signs of toxicity

bw = body weight

Table 4:  Skin Irritation at Application Site – Individual Data – Dose Range Finding Study  

Study Day (Time after Patch Removal)

Animal No. 1

E/O

C

2 (0±2 h)

0/0

nsf

3 (24±2 h)

1/0

nsf

4 (48±2 h)

1/0

nsf

5 (72±2 h)

1/0

des

6

1/1

des

7

0/0

des

8

0/0

des

9

0/0

nsf

10

0/0

nsf

11

0/0

nsf

12

0/0

nsf

13

0/0

nsf

14

0/0

nsf

15

0/0

nsf

h = hours, d = day(s): study day 1 = day of test item application;

C = Comments; E = erythema; O = oedema;nsf = no specific findings;
0, 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404;
des = desquamation

Table 5:  Skin Irritation at Application Site – Individual Data – Main Study

Study Day (Time after Patch Removal)

Animal No. 2

Animal No. 3

E/O

C

E/O

C

2 (0±2 h)

1/0

nsf

1/0

nsf

3 (24±2 h)

1/0

nsf

1/0

s

4 (48±2 h)

1/0

nsf

1/0

s

5 (72±2 h)

2/1

des

1/0

s

6

2/1

des

0/0

s

7

2/1

des

0/0

s

8

1/0

nsf

0/0

nsf

9

1/0

nsf

0/0

nsf

10

0/0

nsf

0/0

nsf

11

0/0

nsf

0/0

nsf

12

0/0

nsf

0/0

nsf

13

0/0

nsf

0/0

nsf

14

0/0

nsf

0/0

nsf

15

0/0

nsf

0/0

nsf

h = hours, d = day(s): study day 1 = day of test item application;

C = Comments; E = erythema; O = oedema;nsf = no specific findings;
0, 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404;
des = desquamation; s = scratches

Table 6:  Absolute Body Weights in g and Body Weight Change in % - DRF and Main Study

Dose: 2000 mg/kg body weight

Animal No. / Sex

g
Day 1

g
Day 8

g
Day 15

%
Day 1-15

1 / female

201

199

207

3

2 / female

220

221

222

1

3 / female

209

207

208

0

bw = body weight


Table 7:  Macroscopic Findings - Individual Data – DRF and Main Study

Dose: 2000 mg/kg bw

Animal No. / Sex

Organ with Macroscopic Findings

Macroscopic Findings

1 / female

Abdominal region

Yellowish solid mass

2 / female

-

nsf

3 / female

-

nsf

nsf = no specific findings



Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Not classified under CLP
Conclusions:
Under the conditions of the present study, single dermal application of the test item 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine to rats at a dose of 2000 mg/kg body weight was associated with neither mortality nor signs of toxicity but signs of irritation. The LD50 was >2000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study (185459), 3 Wistar Crl: WI(Han) female rats were dermally exposed (10% total body area; semi-occlusive) to the test item 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine (99.29%) in sterile water for 24 hours at doses of  2000 mg/kg bw. At the end of the exposure period the residual test item was removed using sterile water.

The LD50 (female) was >2000 mg/kg bw.

In the dose-range finding study with 1 female, the test item showed neither mortality nor signs of acute dermal toxicity but signs of dermal irritation after a single dose application (erythema grade 1, oedema grade 1 and desquamation; all signs of irritation were reversible within up to day 10). A slight weight loss was recorded during the first week, but the animal showed weight gain during the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded. The abdominal region had a yellow solid mass upon necropsy. In the main study with 2 females; the test item showed neither mortality nor signs of acute dermal toxicity. No clinical signs of toxicity were observed throughout the entire observation period. Erythema grade 2 in animal no. 2 and grade 1 in animal no. 3 was observed. Besides erythema, animal no. 2 showed oedema grade 1 and desquamation and animal no. 3 showed scratches. All signs of irritation were reversible within up to day 10. A slight weight loss was recorded for 1 out of 2 female animals during the first week, but all of the female animals showed weight gain during the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded. No specific gross pathological changes were recorded for any other animal in the main study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
There is one key study available for acute dermal toxicity and it is an OECD guideline/GLP study. The quality of the database is high.

Additional information

Acute oral toxcity

There is one acute oral toxicity study in the rat available.

In an acute oral toxicity test (OECD 423/GLP), 2 groups of female Wistar Crl: WI(Han) rats (3/group) were administered 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine (99.29%) in corn oil by oral gavage at a dose of 2000 mg/kg bw. One animal of step 1 was found dead 2 days post-application. All remaining animals survived until the end of the study showing signs of toxicity. The most relevant clinical findings were reduced spontaneous activity, hunched posture, piloerection, eyes half closed, diarrhoea and slight weight loss during the first study week. All animals recovered within up to 8 days post-dose. Throughout the 14-day observation period, the weight gain of the surviving animals was within the normal range of variation for this strain. At necropsy, no treatment-related macroscopic findings were observed in any animal of any step. The LD50 (cut-off) was 2500 mg/kg bw.


Acute dermal toxcity

There is one acute dermal toxicity study in the rat available.

In an acute dermal toxicity study (OECD 402/GLP), 3 Wistar Crl: WI(Han) female rats were dermally exposed (10% total body area; semi-occlusive) to the test item 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine (99.29%) in sterile water for 24 hours at doses of  2000 mg/kg bw. At the end of the exposure period the residual test item was removed using sterile water. In the dose-range finding study with 1 female, the test item showed neither mortality nor signs of acute dermal toxicity but signs of dermal irritation after a single dose application (erythema grade 1, oedema grade 1 and desquamation; all signs of irritation were reversible within up to day 10). A slight weight loss was recorded during the first week, but the animal showed weight gain during the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded. The abdominal region had a yellow solid mass upon necropsy. In the main study with 2 females; the test item showed neither mortality nor signs of acute dermal toxicity. No clinical signs of toxicity were observed throughout the entire observation period. Erythema grade 2 in animal no. 2 and grade 1 in animal no. 3 was observed. Besides erythema, animal no. 2 showed oedema grade 1 and desquamation and animal no. 3 showed scratches. All signs of irritation were reversible within up to day 10. A slight weight loss was recorded for 1 out of 2 female animals during the first week, but all of the female animals showed weight gain during the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded. No specific gross pathological changes were recorded for any other animal in the main study.

The LD50 (female) was >2000 mg/kg bw.

Both of these studies are suitable to use in the human health risk assessment.

Justification for classification or non-classification

Based on the available information in the dossier, the substance 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine (CAS No. 72058-41-4) does not need to be classified for acute toxicity or specific target organ toxicity - single exposure when the criteria outlined in Annex I of 1272/2008/EC are applied.