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EC number: 219-514-3 | CAS number: 2451-62-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline and all individual data included
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Repeated Dose (13 Week) Toxicity and Fertility Study - OECD Method 408; Adopted May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- EC Number:
- 219-514-3
- EC Name:
- 1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- Cas Number:
- 2451-62-9
- Molecular formula:
- C12H15N3O6
- IUPAC Name:
- tris[(oxiran-2-yl)methyl]-1,3,5-triazinane-2,4,6-trione
- Details on test material:
- (2451-62-9) 1,3,5-Triazine-2,4,6(1H,3H,5H)-trione, 1,3,5-tris(oxiranylmethyl PURITY: Technical Grade TGIC-
Araldite PT 810, batch number 407923.48, manufactured on
11/5/94 and stored at 4 degrees centigrade
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- One hundred and thirty three Sprague Dawley rats (45 male and 88 female) of
the Crl CD (SD) BR strain were supplied by Charles River France (76410 Saint-
Aubin-les-Elbeuf, France). Rats were acclimatized for a minimum of 8 days proir to being placed on
study. They were randomly assigned to treatment groups and identified by ear tatoo.
7) At the beginning of the treatment period males were approximately 6 weeks
old and had a mean body weight of 204 grams. 8) Upon arrival at the lab, animals were placed in a disinfected room,
quarantined and given a clinical examination. Temperature was 21 +/- 2 degrees
centigrade, relative humidity was 50 +/- 20%, light/dark cycle was 12hr/12hr,
and ventilation was 12 cycles/hr of filtered, non-recycled air. ""There were no
deviations in temperature and relative humidity which could have influenced the
outcome of the study." Animals had free access to food and water. "There were no known
contaminants in the diet, water or saw dust bedding at levels likely to have
i nfluenced the outcome of the study."
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Exposure Period: 94
Frequency of treatment: Daily
The vehicle used was A04C 2.5 ground diet, batch numbers 40927 and 41114 (U.A.R., 91360 Villemisson-sur-Orge, France).
The diet was mixed; tested for homogeneity, stability and TGIC concentration on weeks 1, 4, 5, 8, 9, and 12); and stored at 4 degrees centigrade.
One hundred and thirty three Sprague Dawley rats (45 male and 88 female) of the Crl CD (SD) BR strain were supplied by Charles River France (76410 Saint-Aubin-les-Elbeuf, France). - Details on mating procedure:
- After 64 days of treatment males were placed with females (1 male and 2
female) overnight. Females were placed with the same male for 7 night or until mating was confirmed. - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Premating exposure period for female: None
Premating exposure period for male: 64 d - Frequency of treatment:
- daily
- Details on study schedule:
- After 64 days of treatment males were placed with females (1 male and 2
female) overnight. Females were placed with the same male for 7 night or until
mating was confirmed.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Males=0.72, 2.08, or 7.32 mg/kg/day; Females=0 mg/kg/day
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10 males and 20 females
- Control animals:
- yes, plain diet
- Details on study design:
- The following parameters were measured: clinical signs, clinical chemistry,
sperm count, pathology mortality, body weight, food consumption and mean food
intake (mg/kg/day), as well as the other parameters required by this guideline. - Positive control:
- none
Examinations
- Parental animals: Observations and examinations:
- clinical signs, clinical chemistry,
sperm count, pathology mortality, body weight, food consumption and mean food
intake (mg/kg/day), as well as the other parameters required by this guideline. - Oestrous cyclicity (parental animals):
- no
- Sperm parameters (parental animals):
- yes, sperm counts, sperm vialbility
- Litter observations:
- none
- Postmortem examinations (parental animals):
- necropsy with gross pathology
Histopathology of major organs ioncluding testes - Postmortem examinations (offspring):
- none
- Statistics:
- Statistical analysis was performed on body weights, food consumption, hematology, blood chemistry, urinalysis, and organ weight data; and the following fertility parameters were calculated: Pre-implantation loss, post-implantation loss, male mating index, male fertility Index, gestation index, life birth index, viability index on day 4, viability index on day 21
- Reproductive indices:
- sperm viability,
sperm counts,
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Reproductive performance:
- no effects observed
Details on results (P0)
2. The average daily intake for the 0, 10, 30, and 100 ppm group was 0, 0.72, 2.08, and 7.32 mg/kg bw, respectively.
3. No mortality occurred during the treatment phase, and no treatment related clinical signs were observed.
4. Body weight development in male rats was reduced during the first 6 weeks, and remained similar to that of the controls til the end of the treatment period. Body weights of the females showed no difference between the dose groups.
5. No significant differencies in food consumption were observed, apart from a slightly lower intake of the high dose group during the first two weeks (-8%).
6. Achieved doses decreased throughout the study as follows:
10 ppm: from 1.16 to 0.05 mg/kg bw
30 ppm: from 3.40 to 1.37 mg/kg bw
100 ppm: from 11.7 to 4.60 mg/kg bw
7. No ophthalmological findings were observed.
8. Slightly lower leucocyte and lymphocyte counts were noted in 2/10 males at 100 ppm, but no relevant blood chemistry and urinalysis findings were recorded 5n male rats.
9. No organ weight differences were recorded, but reddish coloration of mesenteric lymph nodes was observed co0bined with haemosiderosis at males exposed to 100ppm.
10. A slight reduction of spermatozoa was observed in all dose groups, but the viability of sperm was equal among the dose groups.
11. As expected, no abnormal findings were recorded in females, and no differencies in body weight or macroscopical findings were recorded at necropsy.
12. Mating index was 100 % in all groups, and no treatment related unfertility was observed.
13. All litter data from the hysterectomy group were comparable to controls, and the litter data of the delivery groups were also identical to controls. The physical development of the pups was similar to the controls.
14. No effects on pup development was observed.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 100 ppm
- Sex:
- male
- Basis for effect level:
- other: sperm counts, sperm viability, mating behaviour, mating ratio, pathology of major organs, clinical signs, body weight, food consumption
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
No effects on pup development was observed.
Effect levels (F1)
- Key result
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 30 ppm
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Not specified
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Test Results - Reproductive Toxicity |
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Parental Precision/NOAEL: = |
1) The chemical composition of the test article was confirmed at the laboratory |
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The administration of the test article Araldite PT 810 ( TGIC ), by dietary |
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Applicant's summary and conclusion
- Conclusions:
- The administration of the test article Araldite PT 810 ( TGIC ), by dietary admixture for 13 weeks to male Sprague Dawley rats was well tolerated at doses of 10 or 30 ppm ( 0.72 or 2.08 mg/kg/day). Slightly lower (approximately 10%) body weight gain was recorded for the 100 ppm (7.32 mg/kg/day) group. A slight, but dose-related decrease in the mean number of spermatozoa was observed in the TGIC treated groups. No treatment-related infertility was noted in males and no influence on embryonic or pup development was observed after mating with
untreated females. Consequently, 30 ppm was considered as the no observed effect level (NOEL). At 100 ppm, the lower number of spermatozoa did not impair the fertility of the treated males and therefore this dose level was considered
to be the no observed adverse effect level (NOAEL).
Administration of TGIC (PT 810) admixed to the diet for 13 weeks to male rats was well tolerated, causing a slight reduction of body weight gain as well as a slight reduction of the number of spermatozoa at 100 ppm.
The NOEL is 30 ppm (= 2.08 mg/kg bw), and the NOAEL is 100 ppm (= 7.32 mg/kg bw).
Although there was a reduction of the number of sperm with increasing dosing, there were
no effects on fertility observed in the male rats when mated to untreated female rats. The viability of the sperm was comparable in the treated groups to those of the control group. No histopathological chenges were found in the male reproductive organs.
- Executive summary:
The administration of the test article Araldite PT 810 ( TGIC ), by dietary admixture for 13 weeks to male Sprague Dawley rats was well tolerated at doses of 10 or 30 ppm ( 0.72 or 2.08 mg/kg/day). Slightly lower (approximately 10%) body weight gain was recorded for the 100 ppm (7.32 mg/kg/day) group. A slight, but dose-related decrease in the mean number of spermatozoa was observed in the TGIC treated groups. No treatment-related infertility was noted in males and no influence on embryonic or pup development was observed after mating with untreated females. Consequently, 30 ppm was considered as the no observed effect level (NOEL). At 100 ppm, the lower number of spermatozoa did not impair the fertility of the treated males and therefore this dose level was considered to be the no observed adverse effect level (NOAEL
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