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Administrative data

Description of key information

The lowest LD50 value by oral exposure routes in rats was 933 mg/kg bw (male).  The LC50 value by inhalation exposure was 2.932 mg/L (4 hr, rat).

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guideline study with GLP compliance.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
0, 250, 500, 1000, 2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
933 - 1 231 mg/kg bw
Remarks on result:
other: rat
MORTALITY:number of deaths at each dose:

Concentration mg BG Number of animal Number of deaths
w/v%* /kg bw per sex male female
2.5 250 5 0 0
5.0 500 5 0 0
10.0 1000 5 3 1
20.0 2000 5 3 4
BG: benzoguanamine (6-phenyl-1 3 5-triazine-2 4-diyldiamine)
* at 10 ml/kg bw
Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 value = 933 mg/kg (male)
Executive summary:

Test speices, strain: rat, Sprague-Dawley

The major toxicity: edema in the forestomach

Oral LD50Males: 933 mg/kg bw(95% C.L. = 838 to 1808 mg/kg bw)

Females: 1231mg/kg bw (95% C.I. = 583 to 1494 mg/kg bw)

     

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
933 mg/kg bw
Quality of whole database:
The study is a GLP compliant and has Klimisch score 1.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guideline study with GLP compliance.
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
head only
Vehicle:
other: clean dry filtered compressed air
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Single chamber concentration (exposure-dose): 0.687, 1.400, 2.489, 3.365 mg/L by inhalation head only.
the corresponding nominal concentration: 2.726, 6.464, 13.947, 20.167 mg/L
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
A similiar group of 10 rats (5 male and 5 female) was exposed to filtered air as a control
Sex:
male/female
Dose descriptor:
LC50
Effect level:
2.932 mg/L air
95% CL:
> 2.346 - < 4.504
Exp. duration:
4 h
Mortality:
All animals were examined twice daily to detect any which were dead or moribund. Moribund animals were removed and necropsied for human reasons and to prevent autolysis.
Clinical signs:
The animals were observed at hourly intervals during the exposure period, then for the remainder of the working day, and once daily thereafter for 14 days.
Body weight:
The body weight of each animal was recorded immediately before and after exposure, on days 8 and 15 of the study and the necropsy.
Gross pathology:
The following procedure were applied to all animals killed at the end of the study and to those killed in extremis.

Necropsy:
A full internal and external examination was made under the general supervision of a pathologist. The nasal passages were examined and an assessment made of any irritation of the respiratory tract.

Organ weights:
The lungs, bronchi and trachea of the animal were dissected free from fat and other contiguous tissue and weighed together.

Histology:
Sample of all gross lesion were fixed in 10% buffered formalin and retained without further processing.
STATISTICAL RESULT:
-death: Deaths occurred in male and female groups at levels of 2.489 mg/L and above. Overall there was a dose-related relationship between mortality and chamber concentration. All deaths occurred on days one and two of the study.
-body weight gain: Body weight losses occurred in the first week of the study in exposed groups, with a degree of recovery in the second week.
TOXIC EFFECTS:
-clinical chemistry: Marked clinical signs without any specific signs of local lung toxicity were first observed on the day of exposure. The signs included lethargy, ataxia and prostation sometimes accompanied by panting.
-histopathology: There was no treatment-related effect on lung weight in survivors, and only occational increases in lung weight in decedents.
-necroscopy: Animals surviving to termination were unremarkable macrocopically.The only changes in decedents were non-specific pulmonary changes.

Concentration(mg/L)
      mortality on day       Mortality ratio 1 2 3-15 days 1-15
Male control 0 / 5
0.687 0 / 5
1.400 0 / 5
2.489 1 1 / 5
3.365 3 3 / 5
Female control 0 / 5
0.687 0 / 5
1.400 0 / 5
2.489 1 2 3 / 5
3.365 3 3 / 5
Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Harmful if inhaled Criteria used for interpretation of results: EU
Conclusions:
LC50 (4 hr, rat inhalation) = 2.932 mg/L
Executive summary:

In the acute inhalation toxicity study, groups of young adultrat, Aprague-Dawley. male/femalewere exposed by inhalation route to

6 -phenyl-1,3,5 -triazine-2,4 -diyldiamine for 4 hours to head only at concentrations of 0.687, 1.400, 2.489, 3.365 mg/L.  Animals then were observed for 14days.

 

LC50Combined =  2.932  mg/L (95% C.I. 2.346 to 4.504)

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
2.932 mg/m³
Quality of whole database:
The study is a GLP compliant and has Klimisch score 1.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Among the data, the oral rat study [Ogata, (1997)] was identified as the key study because the study is the most relevant and adequate study for chemical safety assessment as well as classification and labelling.

As the result, the LD50 values for acute oral effects are 933 mg/kg bw (male rat) and 1231 mg/kg bw (female rat).

For acute inhalation effects, a LC50 value of 2.932 mg/L is derived.  

There is no information of acute toxicity to humans available.


Justification for selection of acute toxicity – oral endpoint
The study was performed according to OECD guideline study with Klimisch score 1.

Justification for selection of acute toxicity – inhalation endpoint
The study was performed according to OECD guideline study with Klimisch score 1.

Justification for selection of acute toxicity – dermal endpoint
According to annex VII (8.1) column 2, testing by dermal route is not necessary, because data for inhalation toxicity are available and classification is possible.

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008 the substance is classified as Hazard category 4 for acute oral toxicity. In addition, based on the results of the inhalation study the substance is classified as acute toxic after inhalation category 4. For both classifications the substance has to be labelled with the signal word “Caution”