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EC number: 615-086-0 | CAS number: 70225-05-7
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted according to sound scientific principles, similar to OECD TG 421. GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate
- IUPAC Name:
- Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate
- Reference substance name:
- Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- EC Number:
- 222-020-0
- EC Name:
- Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- Cas Number:
- 3319-31-1
- Molecular formula:
- C33H54O6
- IUPAC Name:
- tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- Details on test material:
- Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate
Source: Daihachi Kagaku Kogyo Co., Ltd. Lot. No. N-80301
Purity: >99.0% Kept at room temperature in a dark place until use.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age at study initiation: 10 week old for both sexes.
Weight at study initiation: 373-435 g for males, 217-257 g for females
No. of animals per sex per dose: 12 per sex per dose group
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Administration period: Males for 46 days from 2 weeks prior to mating; Females from 2 weeks prior to mating to day 3 of lactation
Post exposure observation period: None
Terminal kill: Males day 47; Females day 4 of lactation - Details on mating procedure:
- Male/female per cage; 1/1, length of cohabitation; with in the limit of 14 days until proof of pregnancy (formation sperm detection in vagina) was observed.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Males for 46 days from 2 weeks prior to mating; Females from 2 weeks prior to mating to day 3 of lactation
- Frequency of treatment:
- once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0(vehicle), 100, 300, 1000 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 12 per sex per dose group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Administration period: Males for 46 days from 2 weeks prior to mating;
Females from 2 weeks prior to mating to day 3 of lactation
Post exposure observation period: None
Terminal kill: Males day 47; Females day 4 of lactation
The animals were sacrificed on the day 4 of lactation for females.
Males and females with no mated were killed 1 day after the mating period.
Females with no delivery killed 26th day of gestation period.
Vehicle: Corn oil
Mating procedures: Male/female per cage; 1/1, length of cohabitation; with in the limit of 14 days until proof of pregnancy (formation sperm detection in vagina) was observed.
Examinations
- Parental animals: Observations and examinations:
- Clinical observations performed and frequency:
Parent: General appearance once a day
Parameters assessed during study:
Body weight.
Males: Prior to the first dosing and 2, 5, 7, 10, 14 day. After that once a week, the day sacrificed.
Females: Prior to the first dosing and 2, 5, 7, 10, 14 day. During gestation period, 0, 1, 3, 5, 7, 10, 17 and 20 day.
During lactation period, 0, 1, and 4.
During cohabitation period, the same day with male.
Food/water consumption.
The same day when body wt. determined, except lactation period and the day sacrificed for males, also, 0 day of gestationand lactation for female. - Sperm parameters (parental animals):
- Microscopic:
Males: Testis and epididymis. Count of sertoli sells, spermatocytes, round spermatids and elongate spermatids in seminiferous tubules of 5 animals of all dosing groups.(Stage I-VI, VII-VIII, IX-XI, XII-XIV of spermatozoon formative cycle.) - Litter observations:
- Clinical observations performed and frequency:
Pups: General appearance once a day after birth
Parameters assessed during study:
Body weight.
Pups: Day 0 and 4 - Postmortem examinations (parental animals):
- Organs examined at necropsy:
Parent: Males and females: Gross pathlogy of all organs were tested.
Males: Organ weight: Testis and epididymis of all animals.
Female: Organ weight: Ovary of all animals.
Count: Implantation sites and corpus luteum of ovary of all animals.
Microscopic:
Males: Testis and epididymis. Count of sertoli sells, spermatocytes, round spermatids and elongate spermatids in seminiferous tubules of 5 animals of all dosing groups.(Stage I-VI, VII-VIII, IX-XI, XII-XIV of spermatozoon formative cycle.)
Females: Ovary - Postmortem examinations (offspring):
- Pup: Gross pathlogy of all organs were tested. Dead pups and abnormal organs were tested histopathogy.
- Statistics:
- Chi square test for 1 grade positive data and Fisher's test for another. Bartlett's test or Kruskal-Wallis' test for 2 or more grade positive data. And used Dunnett's test or Mann-Whitney's U-test for examination.
- Reproductive indices:
- No. of pairs with successful copulation;
Copulation index (No. of pairs with successful copulation/No. of pairs mated) x 100, duration of mating;
No. of pregnant females;
Fertility index = (No. of pregnant animals/No. of pairs with successful copulation) x 100 - Offspring viability indices:
- No. of corpora lutea;
No. of implantation sites;
Implantation index (No. of implantation sites/No. of corpora lutea) x 100;
No. of pups born, delivery index (No. of pups born/No. of implantation sates) x 100;
No. of live pups born;
Live birth index (No. of live pups born/No. of pups born) x 100, sex ratio of pups;
No. of dead pups born;
Gestation length;
Gestation index (No. of females with live pops delivered/ No. of pregnant females) x 100;
Nursing index (No. of females nursing live pups/No. of females with normal delivery) x 100;
No. of live pups on day 4, viability index (No. of live pups on day 4/No. of live pups born) x 100.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- No adverse effects were observed that affected reproductive function
- Reproductive performance:
- no effects observed
Details on results (P0)
Body weight: No statistical significant difference from controls.
Food/water consumption: No statistical significant difference from controls.
Reproductive data: No statistical significant difference from controls.
Grossly visible abnormalities, external, soft tissue and skeletal abnormalities
Males:
For the control group, atrophy of seminiferous tubules were observed 2 animals and cell debris were observed. There was a slight decrease of spermatids observed in one of the control animals. In the experimental animals, a slight decrease of spermatocytes and spermatids was observed in 2 animals (300 mg/kg) and in 11 animals (1000 mg/kg). A moderate decrease of spermatocytes and spermatids was observed in one animal of 1000 mg/kg/dosing group where a few multinucleate giant cell were noted and a slight vacuolization of sertoli sells were observed. This single animal also had a moderate amount of cell debris, a moderate decrease of spermatids, and a slight granuloma of spermatic in the epididymis.
Number of cells in seminiferous tubules:
Group 1(Stage I-VI): A statistically significant decrease in the number of spermatids at the 300 mg/kg dosing group were observed; a statistically significant decrease in the number of spermatocytes and spermatids were observed for the 1000 mg/kg dosing group.
Group 2(Stage VII-VIII): A statistically significant decrease in the number of round spermatids and ratio of sertoli cells at 1000 mg/kg.
Group 3(stage IX-XI): A statistically significant decrease in the number of elongate spermatids and ratio of sertoli cells at 1000 mg/kg.
Group 4(stage XII-XIV): A statistically significant decrease in the number of spermatocytes, elongate spermatids, and ratio of sertoli cells at 1000 mg/kg dosing group.
Females:
Cyst of corpus luteum of ovary was observed 2 animals of 300 mg/kg dosing group. No abnormal ovaries were observed in the control females 100 mg/kg dosing without successful copulation, or in the 100 mg/kg dosing group without pregnant.
There were no effects observed in any of the following parameters:
1) No. of pairs with successful copulation;
2) Duration of mating ;
3) Copulation index(%);
4) No. of pregnant animals,
5) Fertility index(%);
6) No. of corpora lutea;
7) No. of implantation sites;
8) Implantation index(%);
9) No. of pups born(%);
10) Delivery index(%);
11) Live pups born;
12) Live birth index(%);
13) Sex ratio(M/F);
14) Dead pups born;
15) Gestation length(day);
16) Gestation index(%);
17) Nursing index(%)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: There were no adverse effects observed to fertility for male or for female rats.
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No effects were observed at the highest dose tested.
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
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)
1) No. of pups born (%) – no effects observed;
2) Delivery index (%) – no effects observed;
3) Live pups born – no effects observed;
4) Live birth index(%) – no effects observed;
5) Sex ratio (M/F) – no effects observed;
6) Dead pups born – no effects observed;
7) Live pups on day 4 – no effects observed;
8) Viability index (%)– no effects observed;
9) Body weight of pups – only the 300 mg/kg dosing group for both sexes were statistically significantly decreased;
10) Day 0-4, weight-gain (M and F, in g) – only the 300 mg/kg dosing group for both sexes were statistically significantly decreased;
11) Body weight gain (%) (M and F) – no effects observed.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: There were no adverse developmental effects noted for the F1 pups.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Table 1 - Histopathological finding in rats
Dose (mg/kg bw/day) | ||||
Histopathological endpoint | 0 | 100 | 300 | 1000 |
# of male rats examined | 12 | 12 | 12 | 12 |
Testis: | ||||
Decrease, spermatocyte and spermatid | ||||
Total | 0 | 0 | 2 | 12 |
Slight | 0 | 0 | 2 | 11 |
Moderate | 0 | 0 | 0 | 1 |
Multinuclear giant cell, seminiferous tubule (slight) | 0 | 0 | 0 | 1 |
Vacuolozation, Sertoli cell (slight) | 0 | 0 | 0 | 1 |
Atrophy, seminiferous tubule (slight) | 2 | 0 | 0 | 0 |
Epididymis: | ||||
Cell debris, lumen | ||||
Total | 2 | 0 | 0 | 1 |
Slight | 2 | 0 | 0 | 0 |
Moderate | 0 | 0 | 0 | 1 |
Decrease, sperm | ||||
Total | 1 | 0 | 0 | 1 |
Slight | 1 | 0 | 0 | 0 |
Moderate | 0 | 0 | 0 | 1 |
Granuloma, spermatic (slight) | 0 | 0 | 0 | 1 |
#. of female rats examined | 12 | 12 | 12 | 12 |
Ovary: | ||||
Cyst, corpus luteum | 0 | 0 | 2 | 0 |
Table 2 - Number of cells in seminiferous tubules of male rats.
Dose (mg/kg bw/day) | ||||
Histopathological endpoint | 0 | 100 | 300 | 1000 |
# of male rats examined | 5 | 5 | 5 | 5 |
Group 1 (Stage I-VI) | ||||
No. of Sertoli cells (S.D.) | 20.12(3.18) | 19.08(1.49) | 18.52(1.45) | 18.08(1.45) |
Spermatogonia No. | 16.80(5.65) | 20.52(2.58) | 18.48(3.17) | 15.76(2.61) |
ratio a) | 0.85(0.29) | 1.08(0.19) | 1.01(0.21) | 0.87(0.11) |
Spermatocytes No. | 50.80(7.44) | 51.80(4.84) | 42.64(2.63) | 40.84(5.63)* |
ratio | 2.53(0.13) | 2.72(0.26) | 2.37(0.24) | 2.25(0.16) |
Round spermatids No. | 138.36(17.20) | 128.00(8.89) | 117.68(5.59)* | 112.60(3.11)** |
ratio | 6.91(0.35) | 6.75(0.84) | 6.39(0.70) | 6.26(0.48) |
Elongate spermatids No. | 130.00(21.71) | 132.32(11.17) | 103.28(12.34)* | 95.36(8.44)** |
ratio | 6.53(1.15) | 6.98(0.88) | 5.62(0.90) | 5.30(0.69) |
Group 2 (Stage VII-VIII) | ||||
No. of Sertoli cells (S.D.) | 16.96(2.63) | 17.04(2.17) | 16.64(2.73) | 16.52(2.23) |
Spermatogonia No. | 2.92(1.06) | 2.40(0.93) | 2.04(0.68) | 2.60(1.10) |
ratio a) | 0.18(0.09) | 0.14(0.05) | 0.12(0.03) | 0.16(0.06) |
Spermatocytes No. | 91.68(10.37) | 94.68(6.55) | 84.44(6.99) | 82.32(6.70) |
ratio | 5.45 (0.56) | 5.60(0.51) | 5.16(0.79) | 5.03(0.54) |
Round spermatids No. | 142.08(13.39) | 131.64(13.72) | 123.96(8.23) | 118.76(8.28)* |
ratio | 8.45(0.62) | 7.75(0.39) | 7.66(1.66) | 7.25(0.62)* |
Elongate spermatids No. | 129.24(17.37) | 128.32(16.88) | 114.72(9.80) | 105.65(13.47) |
ratio | 7.78(1.54) | 7.56(0.72) | 7.09(1.62) | 6.46(1.05) |
Group 3 (Stage VII-VIII) | ||||
No. of Sertoli cells (S.D.) | 19.28(1.92) | 20.52(1.55) | 19.20(1.58) | 19.32(2.18) |
Spermatogonia No. | 4.52(1.32) | 4.20(1.50) | 4.92(1.63) | 3.32(1.02) |
ratio a) | 0.23(0.05) | 0.21(0.08) | 0.26(0.11) | 0.18(0.05) |
Spermatocytes No. | 102.52(10.83) | 99.08(8.42) | 97.56(4.50) | 89.04(9.00) |
ratio | 5.34(0.56) | 4.85(0.50) | 5.10(0.36) | 4.62(0.32) |
Elongate spermatids No. | 145.24(11.01) | 130.64(9.90)) | 131.68(19.71) | 119.24(15.90* |
ratio | 7.56(0.61) | 6.37(0.23) | 6.88(1.04) | 6.21(0.83)* |
Group 4 (Stage VII-VIII) | ||||
No. of Sertoli cells (S.D.) | 19.16(2.81) | 20.92(1.73) | 18.64(1.72) | 16.72(0.92) |
Spermatogonia No. | 4.04(0.89) | 3.72(0.72) | 3.64(0.48) | 3.64(0.71) |
ratio a) | 0.21(0.05) | 0.18(0.03) | 0.20(0.02) | 0.22(0.05) |
Spermatocytes No. | 109.80(13.15) | 110.36(9.22) | 99.44(4.54) | 88.76(4.33)** |
ratio | 5.76 (0.29) | 5.28(0.12) | 5.36(0.34) | 5.32(0.46) |
Elongate spermatids No. | 159.76(15.91) | 150.28(18.99) | 137.08(17.70) | 105.16(18.34)** |
ratio | 8.39(0.63) | 7.19(0.71) | 7.35(0.62) | 6.33(1.31)** |
Values are expressed as Mean(S.D.) | ||||
a): (No. of spermatogenic cells/no. of sertoli cells in a seminiferous tubule) |
Table 3 - Influence on reproductive performances of rats
Dose (mg/kg bw/day) | ||||
Endpoint | 0 | 100 | 300 | 1000 |
# of male rats examined | 12 | 12 | 12 | 12 |
No. of male animals examined | 12 | 12 | 12 | 12 |
No. of pairs with successful copulation | 12 | 12 | 12 | 12 |
Duration of mating (day, Mean, (SD)) | 2.1(1.2) | 2.3(1.3) | 2.7(1.2) | 2.7(1.1) |
Copulation index(%)* | 100 | 91.7 | 100 | 100 |
No. of pregnant animals | 11 | 10 | 12 | 12 |
Fertility index(%)** | 91.7 | 90.9 | 100 | 100 |
*(No.of pairs with successful copulation/no.of pairs mated) x 10 | ||||
**(No. of pregnant animals/no.of pairs with successful copulation) x 100 | ||||
Table 4 - Influence on developmental performances of rats
Dose (mg/kg bw/day) | ||||
Endpoint | 0 | 100 | 300 | 1000 |
No. of corpora lutea | 16.8(1.5) | 17.3(1.3) | 17.0(2.3) | 17.9(2.2) |
No. of implantation sites | 15.5(1.7) | 16.6(1.3) | 16.0(2.0) | 16.3(2.3) |
Implantation index(%) a) | 92.5(7.2) | 96.2(6.6) | 94.5(8.4) | 91.3(8.8) |
No. of pups born(%) | 13.7(3.1) | 15.0(1.7) | 15.0(1.8) | 15.1(2.7) |
Delivery index(%) b) | 87.6(15.4) | 90.3(6.8) | 94.1(7.2) | 92.2(9.6) |
Live pups born No. | 13.3(2.9) | 14.7(2.0) | 14.9(2.0) | 15.0(2.7) |
Live birth index(%) c) | 97.1(5.6) | 97.8(3.6) | 99.2(2.6) | 99.4(2.1) |
Sex ratio(M/F) | 1.09(0.69) | 1.05(0.50) | 1.17(0.75) | 0.76(0.44) |
Dead pups born No. | 0.5(0.9) | 0.3(0.5) | 0.1(0.3) | 0.1(0.3) |
Gestation length(day) | 22.7(0.5) | 22.7(0.5) | 22.5(0.5) | 11.6(0.5) |
Gestation index(%) d) | 100 | 100 | 100 | 100 |
Nursing index(%) e) | 100 | 100 | 100 | 100 |
Live pups on day 4 No. | 13.2(2.8) | 14.6(2.1) | 14.4(2.9) | 14.5(2.9) |
Viability index(%) f) | 99.5(1.8) | 99.3(2.3) | 95.6(11.5) | 96.7(6.7 |
Body weight of pups(g) | ||||
Male Day 0 | 7.32(0.77) | 7.13(0.52) | 6.69(0.55) | 6.87(0.84) |
Male Day 4 | 11.71(1.76) | 11.09(0.93) | 10.23(0.98)* | 10.60(1.47) |
Male Day 0-4, gain(g) | 4.39(1.04) | 3.96(0.53) | 3.54(0.77)* | 3.73(0.80) |
Male Body weight gain(%) g) | 59.41(8.87) | 55.54(6.16) | 53.19(11.91) | 54.39(9.50) |
Female Day 0 | 6.93(0.83) | 6.63(0.64) | 6.33(0.58) | 6.58(0.62) |
Female Day 4 | 11.08(1.71) | 10.28(1.01) | 9.84(1.01)* | 10.03(1.46) |
Female Day 0-4, gain(g) | 4.16(1.00) | 3.65(0.56) | 3.14(0.79)* | 3.46(0.96) |
Female Body weight gain(%) | 59.63(10.42) | 55.24(8.07) | 49.95(13.09) | 52.17(11.10) |
Values are expressed as Mean (S.D.) | ||||
Significantly difference from 0 mg/kg group ; p < 0.05 | ||||
a): (No. of implantation sites/no. of corpora lutea) x 100 | ||||
b): (No. of pups born/no. of implantation sites) x 100 | ||||
c): (No. of live pups born/no. of pups born) x 100 | ||||
d): (No. of females with live pups delivered/ no. of pregnant remales) x 100 | ||||
e): (No. of females nursing live pups/no. of females with normal delivery) x 100 | ||||
f): ( No. of live pups on day 4/ no. of live pups born) x 100 | ||||
g): ( Body weight gain/body weight on day 0) x 100 | ||||
Applicant's summary and conclusion
- Conclusions:
- The reproductive NOAEL for the test material was determined to be >1000 mg/kg bw/day, the highest dose tested, for male and female rats (P generation). The developmental NOAEL was determined to be >1000 mg/kg bw/day, the highest dose tested, for the F1 generation as no fetotoxic, developmental, or teratogenic effects were observed.
Classification as a reproductive or developmental toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations. - Executive summary:
Male Crj: CD(SD) rats were treated with the test material for 46 days starting from 2 weeks prior to mating; female Crj: CD(SD) rats were treated with the test material starting from 2 weeks prior to mating to day 3 of lactation. Male amd female rats were cohabitated for up to 14 days or until proof of pregnancy was observed. Clinical observations, body weight, and food/water consumption were observed during the experimental period. Several indices for reproductive and for developmental performance were evaluated. Both male and female rats as well as the resulting pups were sacrificed and examined for gross pathology and for histopathological changes to the reproductive organs.
The reproductive NOAEL for the test material was determined to be >1000 mg/kg bw/day, the highest dose tested, for male and female rats (P generation). The developmental NOAEL was determined to be >1000 mg/kg bw/day, the highest dose tested, for the F1 generation as no fetotoxic, developmental, or teratogenic effects were observed.
Classification as a reproductive or developmental toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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