Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 276-309-1 | CAS number: 72058-41-4
- 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
Acute Toxicity: dermal
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine
- EC Number:
- 276-309-1
- EC Name:
- 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine
- Cas Number:
- 72058-41-4
- Molecular formula:
- C11H18Cl2N4
- IUPAC Name:
- 4,6-dichloro-N-(2,4,4-trimethylpentan-2-yl)-1,3,5-triazin-2-amine
- Test material form:
- solid
- Details on test material:
- Colour: light yellow
Constituent 1
- 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.
Test animals
- Species:
- rat
- Strain:
- other: WISTAR Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system 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
Administration / exposure
- 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.
Results and discussion
- 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.
Effect levels
- 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:
- other: 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 a
- Gross pathology:
- No specific gross pathological changes were recorded for any other animal in the main study (Table 7).
Any other information on results incl. tables
Table 2: Clinical Signs of Systemic Toxicity - Individual Data – Dose Range Finding Study
Animal |
Time of Observation |
Observation |
1 / female / |
during the whole observation period |
no signs of toxicity |
bw = body weight
Table 3: Clinical Signs of Systemic Toxicity - Individual Data – Main Study
Animal |
Time of Observation |
Observations |
2 / female / |
during the whole observation period |
no signs of toxicity |
3 / female / |
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; |
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; |
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 |
g |
g |
% |
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
Applicant's summary and conclusion
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.