Registration Dossier
Registration Dossier
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EC number: 231-912-9 | CAS number: 7778-74-7
Toxicological information
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- The test animals were obtained from Charles River Laboratories (Raleigh, NC)and aged 59 days (female) and 73 days (male), respectively.
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- Exposure was started 14 days before cohabitation and continued through sacrifice.
- Duration of treatment / exposure:
- 90 days for exposure period starting 14 days prior to cohabitation.
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- control group
- Dose / conc.:
- 0.01 mg/kg bw/day (nominal)
- Dose / conc.:
- 0.1 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 mg/kg bw/day (nominal)
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- control group; consumed average doses during the 3-week gestation period
- Dose / conc.:
- 0.01 mg/kg bw/day (actual dose received)
- Remarks:
- consumed average doses during the 3-week gestation period
- Dose / conc.:
- 0.08 mg/kg bw/day (actual dose received)
- Remarks:
- consumed average doses during the 3-week gestation period
- Dose / conc.:
- 0.7 mg/kg bw/day (actual dose received)
- Remarks:
- consumed average doses during the 3-week gestation period
- Dose / conc.:
- 21.69 mg/kg bw/day (actual dose received)
- Remarks:
- consumed average doses during the 3-week gestation period
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- All rats in the main study and in the satellite study were observed for viability at least twice daily and for general appearance at least once during the pre-exposure period.
daily examination during the exposure period for clinical observations: effects abortions, premature deliveries, and deaths caused by the test item
daily recording of: body weights, feed and water consumption
A main study (fetal examination at day 21 after mating) and a satellite study (maternal and fetal blood samples for determination of T3, T4 and TSH levels) were performed. - Fetal examinations:
- Cesarean-sectioning observations on day 21 after mating were based on 19, 19, 17, 20, and 20 pregnant dams in the five respective exposure groups.
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Effects were considered non-treatment related as they were not dose-dependent.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Only transient and of a singular occurence increases and decreases measured, not statistically significant.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes in concentrations of thyroid hormons (TSH, T4, T3) and increase in thyroid weights, see detailed table.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- effects observed, treatment-related
- Description (incidence and severity):
- The averages for litter size and for the number of live fetuses were significantly reduced (p <= 0.05) in the 30.0 mg/kg-day exposure group.
These reductions were not considered treatment-related because:
(1) the values were within the ranges observed historically at the testing fadlity
(2) the values were not loxicologically important because there were no significant increases in fetal deaths or resorptions nor significant reductions in number of implantations. - Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- no effects observed
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- clinical biochemistry
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: no effect was observed at this concentration
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- not examined
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- general fetale alterations, not further specified:
All alterations observed were determined to be unrelated to the test substance because the incidences were not exposure dependent; the observalion occurred in anly one or two high-exposure group fetuses; or the incidences are within the averages observed historically at the laboratory.
Changes in concentrations of thyroid hormons (TSH, T4, T3) and increase in thyroid weights, see detailed table. - Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Changes in concentrations of thyroid hormons (TSH, T4, T3), increase in thyroid weights and developmental delays in ossification.
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 30 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects in the absence of maternal toxicity effects
- Dose response relationship:
- yes
- Relevant for humans:
- yes
- Key result
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 1 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Conclusions:
- A developmental toxicity study was conducted with ammonium perchlorate (AP) in the drinking water at doses of 0.0, 0.01, 0.1, 1.0, and 30.0 mg/kg-day beginning 14 days before cohabitation and continuing through sacrifice. Twenty-four rats/group were cesarean-sectioned on day of gestation (DG) 21 and fetuses examined for visceral and skeletal alterations. An additional 16 litters/group were sacrificed on DG 21 for maternal and fetal serum TSH, T(3), and T(4) (thyroid-stimulating hormone, triiodothyronine, and thyroxine) levels and thyroid histopathology. Clinical and necropsy observations, body weights, feed and water consumption, and cesarean-sectioning parameters were comparable among the groups with only delays in ossification observed in the 30 mg/kg-day group. Maternal thyroid weights were increased in the 30.0 mg/kg-day group. Decreased colloid was present in male and female fetal thyroids in the 1.0 and 30.0 mg/kg-day groups. Maternal TSH was increased and T(4) was decreased at all levels, and T(3) was reduced at 30.0 mg/kg-day. Fetal TSH was increased at 1.0 and 30.0 mg/kg-day, T(4) was reduced at 30.0 mg/kg-day, and T(3) was decreased at all levels. The maternal no-observable-adverse-effect level (NOAEL) was 1.0 mg/kg-day; exposures of 30.0 mg/kg-day increased absolute and relative maternal thyroid weights and histopathology findings. The developmental NOAEL was 1.0 mg/kg-day; developmental delays in ossification occurred in the 30.0 mg/kg-day group. The colloid depletion in the thyroids and increased TSH and decreased T(3) and T(4) levels at lower exposures were considered adaptive and not adverse. No adverse effects on development at occurred levels that did not cause maternal toxicity.
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- In water, potassium perchlorate will rapidly dissolve and completely dissociate into the perchlorate anion and the corresponding cation. Toxicity is determined only by the perchlorate moiety of the salt. as potassium is known to be non-toxic. Based on that, read-across is possible to other perchlorate salt dissociating in water without any toxic cation.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- The test animals were obtained from Charles River Laboratories (Raleigh, NC)and aged 59 days (female) and 73 days (male), respectively.
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- Exposure was started 14 days before cohabitation and continued through sacrifice.
- Duration of treatment / exposure:
- 90 days for exposure period starting 14 days prior to cohabitation.
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- control group
- Dose / conc.:
- 0.01 mg/kg bw/day (nominal)
- Dose / conc.:
- 0.1 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 mg/kg bw/day (nominal)
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- control group; consumed average doses during the 3-week gestation period
- Dose / conc.:
- 0.01 mg/kg bw/day (actual dose received)
- Remarks:
- consumed average doses during the 3-week gestation period
- Dose / conc.:
- 0.08 mg/kg bw/day (actual dose received)
- Remarks:
- consumed average doses during the 3-week gestation period
- Dose / conc.:
- 0.7 mg/kg bw/day (actual dose received)
- Remarks:
- consumed average doses during the 3-week gestation period
- Dose / conc.:
- 21.69 mg/kg bw/day (actual dose received)
- Remarks:
- consumed average doses during the 3-week gestation period
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- All rats in the main study and in the satellite study were observed for viability at least twice daily and for general appearance at least once during the pre-exposure period.
daily examination during the exposure period for clinical observations: effects abortions, premature deliveries, and deaths caused by the test item
daily recording of: body weights, feed and water consumption
A main study (fetal examination at day 21 after mating) and a satellite study (maternal and fetal blood samples for determination of T3, T4 and TSH levels) were performed. - Fetal examinations:
- Cesarean-sectioning observations on day 21 after mating were based on 19, 19, 17, 20, and 20 pregnant dams in the five respective exposure groups.
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Effects were considered non-treatment related as they were not dose-dependent.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Only transient and of a singular occurence increases and decreases measured, not statistically significant.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes in concentrations of thyroid hormons (TSH, T4, T3) and increase in thyroid weights, see detailed table.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- effects observed, treatment-related
- Description (incidence and severity):
- The averages for litter size and for the number of live fetuses were significantly reduced (p <= 0.05) in the 30.0 mg/kg-day exposure group.
These reductions were not considered treatment-related because:
(1) the values were within the ranges observed historically at the testing fadlity
(2) the values were not loxicologically important because there were no significant increases in fetal deaths or resorptions nor significant reductions in number of implantations. - Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- no effects observed
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- clinical biochemistry
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: no effect was observed at this concentration
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- not examined
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- general fetale alterations, not further specified:
All alterations observed were determined to be unrelated to the test substance because the incidences were not exposure dependent; the observalion occurred in anly one or two high-exposure group fetuses; or the incidences are within the averages observed historically at the laboratory.
Changes in concentrations of thyroid hormons (TSH, T4, T3) and increase in thyroid weights, see detailed table. - Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Changes in concentrations of thyroid hormons (TSH, T4, T3), increase in thyroid weights and developmental delays in ossification.
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 30 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects in the absence of maternal toxicity effects
- Dose response relationship:
- yes
- Relevant for humans:
- yes
- Key result
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 1 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Conclusions:
- A developmental toxicity study was conducted with ammonium perchlorate (AP) in the drinking water at doses of 0.0, 0.01, 0.1, 1.0, and 30.0 mg/kg-day beginning 14 days before cohabitation and continuing through sacrifice. Twenty-four rats/group were cesarean-sectioned on day of gestation (DG) 21 and fetuses examined for visceral and skeletal alterations. An additional 16 litters/group were sacrificed on DG 21 for maternal and fetal serum TSH, T(3), and T(4) (thyroid-stimulating hormone, triiodothyronine, and thyroxine) levels and thyroid histopathology. Clinical and necropsy observations, body weights, feed and water consumption, and cesarean-sectioning parameters were comparable among the groups with only delays in ossification observed in the 30 mg/kg-day group. Maternal thyroid weights were increased in the 30.0 mg/kg-day group. Decreased colloid was present in male and female fetal thyroids in the 1.0 and 30.0 mg/kg-day groups. Maternal TSH was increased and T(4) was decreased at all levels, and T(3) was reduced at 30.0 mg/kg-day. Fetal TSH was increased at 1.0 and 30.0 mg/kg-day, T(4) was reduced at 30.0 mg/kg-day, and T(3) was decreased at all levels. The maternal no-observable-adverse-effect level (NOAEL) was 1.0 mg/kg-day; exposures of 30.0 mg/kg-day increased absolute and relative maternal thyroid weights and histopathology findings. The developmental NOAEL was 1.0 mg/kg-day; developmental delays in ossification occurred in the 30.0 mg/kg-day group. The colloid depletion in the thyroids and increased TSH and decreased T(3) and T(4) levels at lower exposures were considered adaptive and not adverse. No adverse effects on development at occurred levels that did not cause maternal toxicity.
The NOAEL for ammonium perchlorate was determined to be 1.00 mg /kg bw/d.
The NOAEL for potassium perchlorate is 1.18 mg /kg bw/d.
The LOAEL for ammonium perchlorate was determined to be 30.0 mg /kg bw/d.
The LOAEL for potassium perchlorate is 35.4 mg /kg bw/d.
Referenceopen allclose all
Cesarean-sectioning observations, all doses reported in nominal concentrations mg/kg bw/day
| parameter | 0.0 | 0.01 | 0.1 | 1.0 | 30.0 |
| litters | 19 | 19 | 17 | 20 | 20 |
| % pregnant | 95 | 95 | 85 | 100 | 100 |
| corpora lutea | 19.3 | 17.9 | 18.1 | 19.8 | 19.8 |
| implants | 17.0 | 14.7 | 14.4 | 16.6 | 14.8 |
| preimplantation losses | 2.3 (12%) | 3.2 (18%) | 3.7 (20%) | 3.2 (16%) | 5.0 (25%) |
| litter size | 16.6 | 14.3 | 13.9 | 16.2 | 14.8 |
| no. of fetuses | 316 | 271 | 236 | 325 | 282 |
| early resorptions | 0.4 | 0.4 | 0.5 | 0.4 | 0.8 |
| late resorptions | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| male fetuses per litter | 47.2 | 53.0 | 47.3 | 50.9 | 47.8 |
| fetal weight per litter | 4.30 | 4.45 | 4.62 | 4.54 | 4.49 |
| male fetal body weight | 4.40 | 4.59 | 4.74 | 4.68 | 4.48 |
| female fetal body weight | 4.20 | 4.28 | 4.49 | 4.40 | 4.38 |
fetal alteration observations in rat litters, all doses reported in nominal concentrations mg/kg bw/day
| parameter | 0.0 | 0.01 | 0.1 | 1.0 | 30.0 |
| fetuses | 316 | 271 | 236 | 325 | 282 |
| litters | 19 | 19 | 17 | 20 | 20 |
| litters with any alteration | 7 (36.8%) | 4 (21.0%) | 8 (47.0%) | 4 (20.0%) | 4 (20.0%) |
| fetuses with any alteration | 8 (2.5%) | 4 (1.5%) | 12 (5.1%) | 5 (1.5%) | 5 (1.8%) |
| % fetuses with any alteration per litter | 2.6 | 1.3 | 5.2 | 1.5 | 1.9 |
Developmental delays in ossification occurred in the 30.0 mg/kg-day group.
Thyroid effects in satellite group rats, all doses reported in nominal concentrations mg/kg bw/day
| parameter | 0.0 | 0.01 | 0.1 | 1.0 | 30.0 |
| terminal body weight (g) | 412.5 | 423.2 | 423.8 | 424.0 | 427.0 |
| absolute thyroid weight (mg) | 18.36 | 18.81 | 20.48 | 21.49 | 26.28 |
| relative thyroid weight | 0.04 | 0.04 | 0.05 | 0.05 | 0.06 |
| decreased colloid | 0/16 | 0/16 | 0/16 | 0/15 | 16/16 |
hypertrophy |
0/16 |
0/16 |
0/16 |
0/15 |
14/16 |
hyperplasia |
0/16 |
0/16 |
0/16 |
0/15 |
2/16 |
TSH (ng/mL) |
6.05 |
8.18 |
9.09 |
9.94 |
14.87 |
T4 (µg/dL) |
2.31 |
2.06 |
1.28 |
1.19 |
1.06 |
T3 (ng/dL) |
99.7 |
97.3 |
95.8 |
93.1 |
87.4 |
Thyroid effects in satellite group rat fetuses, all doses reported in nominal concentrations mg/kg bw/day
| parameter | 0.0 | 0.01 | 0.1 | 1.0 | 30.0 |
| male fetuses - decreased colloid | 0/16 | 2/16 | 0/16 | 12/16 | 16/16 |
| male fetuses - hypertrophy | 0/16 | 0/16 | 0/16 | 0/16 | 0/16 |
| male fetuses - hyperplasia | 0/16 | 0/16 | 0/16 | 1/16 | 0/16 |
| female fetuses - decreased colloid | 0/16 | 1/16 | 1/16 | 13/16 | 16/16 |
| female fetuses - hypertrophy | 0/16 | 0/16 | 0/16 | 0/16 | 0/16 |
| female fetuses - hyperplasia | 0/16 | 0/16 | 0/16 | 1/16 | 0/16 |
| TSH (ng/mL) | 7.22 | 7.29 | 7.80 | 8.26 | 10.78 |
| T4 (µg/dL) | 1.59 | 1.50 | 1.47 | 1.46 | 1.38 |
| T3 (ng/dL) | 23.4 | 19.3 | 16.9 | 16.7 | 15.6 |
Cesarean-sectioning observations, all doses reported in nominal concentrations mg/kg bw/day
| parameter | 0.0 | 0.01 | 0.1 | 1.0 | 30.0 |
| litters | 19 | 19 | 17 | 20 | 20 |
| % pregnant | 95 | 95 | 85 | 100 | 100 |
| corpora lutea | 19.3 | 17.9 | 18.1 | 19.8 | 19.8 |
| implants | 17.0 | 14.7 | 14.4 | 16.6 | 14.8 |
| preimplantation losses | 2.3 (12%) | 3.2 (18%) | 3.7 (20%) | 3.2 (16%) | 5.0 (25%) |
| litter size | 16.6 | 14.3 | 13.9 | 16.2 | 14.8 |
| no. of fetuses | 316 | 271 | 236 | 325 | 282 |
| early resorptions | 0.4 | 0.4 | 0.5 | 0.4 | 0.8 |
| late resorptions | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| male fetuses per litter | 47.2 | 53.0 | 47.3 | 50.9 | 47.8 |
| fetal weight per litter | 4.30 | 4.45 | 4.62 | 4.54 | 4.49 |
| male fetal body weight | 4.40 | 4.59 | 4.74 | 4.68 | 4.48 |
| female fetal body weight | 4.20 | 4.28 | 4.49 | 4.40 | 4.38 |
fetal alteration observations in rat litters, all doses reported in nominal concentrations mg/kg bw/day
| parameter | 0.0 | 0.01 | 0.1 | 1.0 | 30.0 |
| fetuses | 316 | 271 | 236 | 325 | 282 |
| litters | 19 | 19 | 17 | 20 | 20 |
| litters with any alteration | 7 (36.8%) | 4 (21.0%) | 8 (47.0%) | 4 (20.0%) | 4 (20.0%) |
| fetuses with any alteration | 8 (2.5%) | 4 (1.5%) | 12 (5.1%) | 5 (1.5%) | 5 (1.8%) |
| % fetuses with any alteration per litter | 2.6 | 1.3 | 5.2 | 1.5 | 1.9 |
Developmental delays in ossification occurred in the 30.0 mg/kg-day group.
Thyroid effects in satellite group rats, all doses reported in nominal concentrations mg/kg bw/day
| parameter | 0.0 | 0.01 | 0.1 | 1.0 | 30.0 |
| terminal body weight (g) | 412.5 | 423.2 | 423.8 | 424.0 | 427.0 |
| absolute thyroid weight (mg) | 18.36 | 18.81 | 20.48 | 21.49 | 26.28 |
| relative thyroid weight | 0.04 | 0.04 | 0.05 | 0.05 | 0.06 |
| decreased colloid | 0/16 | 0/16 | 0/16 | 0/15 | 16/16 |
hypertrophy |
0/16 |
0/16 |
0/16 |
0/15 |
14/16 |
hyperplasia |
0/16 |
0/16 |
0/16 |
0/15 |
2/16 |
TSH (ng/mL) |
6.05 |
8.18 |
9.09 |
9.94 |
14.87 |
T4 (µg/dL) |
2.31 |
2.06 |
1.28 |
1.19 |
1.06 |
T3 (ng/dL) |
99.7 |
97.3 |
95.8 |
93.1 |
87.4 |
Thyroid effects in satellite group rat fetuses, all doses reported in nominal concentrations mg/kg bw/day
| parameter | 0.0 | 0.01 | 0.1 | 1.0 | 30.0 |
| male fetuses - decreased colloid | 0/16 | 2/16 | 0/16 | 12/16 | 16/16 |
| male fetuses - hypertrophy | 0/16 | 0/16 | 0/16 | 0/16 | 0/16 |
| male fetuses - hyperplasia | 0/16 | 0/16 | 0/16 | 1/16 | 0/16 |
| female fetuses - decreased colloid | 0/16 | 1/16 | 1/16 | 13/16 | 16/16 |
| female fetuses - hypertrophy | 0/16 | 0/16 | 0/16 | 0/16 | 0/16 |
| female fetuses - hyperplasia | 0/16 | 0/16 | 0/16 | 1/16 | 0/16 |
| TSH (ng/mL) | 7.22 | 7.29 | 7.80 | 8.26 | 10.78 |
| T4 (µg/dL) | 1.59 | 1.50 | 1.47 | 1.46 | 1.38 |
| T3 (ng/dL) | 23.4 | 19.3 | 16.9 | 16.7 | 15.6 |
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Justification for classification or non-classification
Additional information
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