Chlorosulphuric acid

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

Reproductive Toxicity Study:

An inhalation study was performed to assess the effects of the test chemical on the reproductive and developmental toxicity on the test animals. In this study, 2 groups of 8–15 female rats were exposed to a concentration of 302 ml/m3 of the test chemical (450 mg/m3 ) for one hour. One group was exposed 12 days before and the other group 9 days after gestation. Both groups demonstrated symptoms of haemorrhagic oedema in the lungs, severe dyspnoe and cyanosis. One-third of the animals died. Fetal mortality was significantly increased in the group of rats which had been exposed during gestation. Among the progeny of dams which had been exposed 12 days prior to gestation, body weight gain was significantly reduced until the pups were 4 weeks old, while in the male progeny of dams exposed to hydrogen chloride, functional disorders of lungs, kidneys and livers were seen in both exposure groups.

Link to relevant study records

Reference

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Weight of evidence based on the data from the test chemicals.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD 414 (Pre-Natal Developmental Toxicity Screening Test)

Principles of method if other than guideline:

The above experiment was performed to evaluate and assess the reproductive and devlopmental toxicity of the test chemical on the test animal.

GLP compliance:

not specified

Justification for study design:

No Data Available

Specific details on test material used for the study:

- Molecular weight (if other than submission substance): 116.5239 g/mol
- Substance type: Inorganic
- Physical state: No Data Available
- Impurities (identity and concentrations): No Data Available

Species:

other: Study 2: Rat; Study 3:

Strain:

other: Study 2: Wistar; Study 3: CF-1

Details on species / strain selection:

No Data Available

Sex:

female

Details on test animals or test system and environmental conditions:

Study 2:
No Data Available

Route of administration:

other: Study 2: Inhalation;aerosol and 3: inhalation

Type of inhalation exposure (if applicable):

other: Study 3: Whole Body

Vehicle:

not specified

Details on exposure:

Study 2: 2 groups of 8–15 female rats were exposed to a concentration of 302 ml/m3 of the test chemical (450 mg/m3) for one hour. One group was exposed 12 days before and the other group 9 days after gestation.

Study 3: The animals were exposed to the test chemical for a period of 10 days (GD 6 to 15) for 7 hours a day.

Details on mating procedure:

No Data Available

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

No Data Available

Duration of treatment / exposure:

Study 2: 12 days before gestation and 9 days after gestation.
Study 3: 10 days.

Frequency of treatment:

Study 2: No Data Available
Study 3: Once (7 hours/Day)

Details on study schedule:

No Data Available

Remarks:

Study 2: 0 and 302 ml/m3 (450 mg/m3) of the test chemical.
Study 3: 0, 5, 20 mg/m3 of the test chemical.

No. of animals per sex per dose:

Study 2: 8-15 female rats

Control animals:

yes

Details on study design:

No Data Available

Positive control:

No Data Available

Parental animals: Observations and examinations:

Study 2: Clinical Signs and Mortality was observed.
Study 3: Mean Implantation, Resorptions per litter were observed.

Oestrous cyclicity (parental animals):

No Data Available

Sperm parameters (parental animals):

No Data Available

Litter observations:

Study 2: Clinical Signs, Mortality and body weight of the fetus was observed
Study 3: Viability of the litters were observed.

Postmortem examinations (parental animals):

Study 2: Gross Necropsy was performed.
Study 3: Implantations and Resorptions of females were counted.

Postmortem examinations (offspring):

Study 2: Gross Necropsy of the offsprings was performed.
Study 3: Implantations and Resorptions of females were counted.

Statistics:

No Data Available

Reproductive indices:

No Data Available

Offspring viability indices:

No Data Available

Clinical signs:

effects observed, treatment-related

Description (incidence and severity):

Study 2: Dyspnoe and cyanosis was observed in all the treated animals.

Dermal irritation (if dermal study):

not specified

Mortality:

mortality observed, treatment-related

Description (incidence):

Study 2: One-third of the animals died after the exposure to the test chemical.

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Histopathological findings: non-neoplastic:

no effects observed

Description (incidence and severity):

Study 3: No significant effects on mean numbers of implants/dam, and resorptions/litter were observed in mice.

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Reproductive function: oestrous cycle:

not specified

Reproductive function: sperm measures:

not specified

Reproductive performance:

not specified

Study 2: Adverse effects of Clinical Signs and also Mortality was observed in maternal animals.
Study 3: No significant effects on mean numbers of implants/dam, and resorptions/litter were observed in mice.

Dose descriptor:

LOAEL

Effect level:

450 mg/m³ air

Based on:

test mat.

Sex:

male/female

Basis for effect level:

clinical signs

mortality

gross pathology

Remarks on result:

other: Not Specified

Critical effects observed:

not specified

System:

other: Not Specified

Clinical signs:

not specified

Dermal irritation (if dermal study):

not specified

Mortality / viability:

mortality observed, treatment-related

Description (incidence and severity):

Study 2: Fetal mortality was significantly increased in the group of rats which had been exposed during gestation.
Study 3: no mortality observed

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

Study 2: Among the progeny of dams which had been exposed 12 days prior to gestation, body weight gain was significantly reduced until the pups were 4 weeks old.

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Sexual maturation:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

effects observed, treatment-related

Description (incidence and severity):

Study 2: In the male progeny of dams exposed to hydrogen chloride, functional disorders of lungs, kidneys and livers were seen in both exposure groups.

Histopathological findings:

not specified

Other effects:

not specified

Behaviour (functional findings):

not specified

Developmental immunotoxicity:

not specified

Study 2: Effects on body weight were observed. Mortality was observed in treated groups. Adverse effects in gross necropsy were observed.
Study 3: No effects and viabilty of the fetus and other fetotoxicity of the test chemical.

Dose descriptor:

LOAEL

Generation:

F1

Effect level:

450 mg/m³ air

Based on:

test mat.

Sex:

male/female

Basis for effect level:

viability

mortality

body weight and weight gain

gross pathology

Remarks on result:

other: Not Specified.

Critical effects observed:

not specified

System:

other: Not Specified

Reproductive effects observed:

not specified

Treatment related:

not specified

Conclusions:

Study 2: The LOAEL value for the test chemical after exposure of dams on 12 days before and the other group 9 days after gestation was found to be 450 mg/m3.

Study 3: Based on all the observations and results, it was concluded that the NOAEL for the maternal animals was 20 mg/m3 and the NOEL for fetal parameters was 20 mg/m3.

Executive summary:

Reproductive Toxicity Studies:

The summaries of the reproductive toxicity data are as follows:

Reproductive Toxicity Study 2:

An inhalation study was performed to assess the effects of the test chemical on the reproductive and developmental toxicity on the test animals. In this study, 2 groups of 8–15 female rats were exposed to a concentration of 302 ml/m3 of the test chemical (450 mg/m3 ) for one hour. One group was exposed 12 days before and the other group 9 days after gestation. Both groups demonstrated symptoms of haemorrhagic oedema in the lungs, severe dyspnoe and cyanosis. One-third of the animals died. Fetal mortality was significantly increased in the group of rats which had been exposed during gestation. Among the progeny of dams which had been exposed 12 days prior to gestation, body weight gain was significantly reduced until the pups were 4 weeks old, while in the male progeny of dams exposed to hydrogen chloride, functional disorders of lungs, kidneys and livers were seen in both exposure groups.

Reproductive Toxicity Study 3:

An inhalation toxicity study was conducted on the CF-1 mice, to assess and evaluate the effects on the developmental parameters of the fetuses born to the maternal animals exposed to the test chemicals. In this study, time-mated maternal animals were exposed to the test chemical in the concentration of 0, 5, 20 mg/m3 during day 6 to 15 of gestation. The animals were exposed 7hours/day to the test chemical. In maternal parameters, mean implants/dams, resorption/litter, Live fetuses were observed. Also, viability of the fetuses were observed. After all the observations, it was seen that there was no significant effects on mean numbers of implants/dam, live fetuses/litter or resorptions/litter were observed in mice. Also, there were no difference in the viability of the pups when compared to the control group. Thus, based on all the observations and results, it was concluded that the NOAEL for the maternal animals was 20 mg/m3 and the NOEL for the test chemical for fetal parameters was 20 mg/m3.

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Effect on fertility: via inhalation route

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LOAEC

450 mg/m³

Study duration:

chronic

Species:

rat

Quality of whole database:

Data is of Klimisch 4 database.

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Reproductive Toxicity Studies:

The summaries of the reproductive toxicity data are as follows:

Reproductive Toxicity Study 2:

An inhalation study was performed to assess the effects of the test chemical on the reproductive and developmental toxicity on the test animals. In this study, 2 groups of 8–15 female rats were exposed to a concentration of 302 ml/m3 of the test chemical (450 mg/m3 ) for one hour. One group was exposed 12 days before and the other group 9 days after gestation. Both groups demonstrated symptoms of haemorrhagic oedema in the lungs, severe dyspnoe and cyanosis. One-third of the animals died. Fetal mortality was significantly increased in the group of rats which had been exposed during gestation. Among the progeny of dams which had been exposed 12 days prior to gestation, body weight gain was significantly reduced until the pups were 4 weeks old, while in the male progeny of dams exposed to hydrogen chloride, functional disorders of lungs, kidneys and livers were seen in both exposure groups.

Reproductive Toxicity Study 3:

An inhalation toxicity study was conducted on the CF-1 mice, to assess and evaluate the effects on the developmental parameters of the fetuses born to the maternal animals exposed to the test chemicals. In this study, time-mated maternal animals were exposed to the test chemical in the concentration of 0, 5, 20 mg/m3 during day 6 to 15 of gestation. The animals were exposed 7hours/day to the test chemical. In maternal parameters, mean implants/dams, resorption/litter, Live fetuses were observed. Also, viability of the fetuses were observed. After all the observations, it was seen that there was no significant effects on mean numbers of implants/dam, live fetuses/litter or resorptions/litter were observed in mice. Also, there were no difference in the viability of the pups when compared to the control group. Thus, based on all the observations and results, it was concluded that the NOAEL for the maternal animals was 20 mg/m3 and the NOEL for the test chemical for fetal parameters was 20 mg/m3.

Effects on developmental toxicity

Description of key information

Developmental Toxicity Study:

An inhalation study was performed to assess the effects of the test chemical on the reproductive and developmental toxicity on the test animals. In this study, 2 groups of 8–15 female rats were exposed to a concentration of 302 ml/m3 of the test chemical (450 mg/m3 ) for one hour. One group was exposed 12 days before and the other group 9 days after gestation. Both groups demonstrated symptoms of haemorrhagic oedema in the lungs, severe dyspnoe and cyanosis. One-third of the animals died. On the 5th day after exposure the blood (mixed) oxygen saturation was lowered in treated pregnant rats as comp[ared to the control group. An increase in the concentration of chlorides in the urine of the pregnant rats and also in the protein concentration in the urine as compared to the control group was observed. The relative weights of the organs in the experimental pregnant animals were indistinguishable from those of the controls. Injury to maternal organs, especially the endocrine glands, heart, and liver, during pregnancy was observed after exposure to the test chemical. The lungs of the dying rats were congested, with areas of edema and hemorrhage. Lung function was disturbed in the surviving females. Kidney function was disturbed in treated pregnant animals as compared to the control group. Changes in liver function were found in the pregnant animals. Fetal mortality was significantly increased in the group of rats which had been exposed during gestation. Among the progeny of dams which had been exposed 12 days prior to gestation, body weight gain was significantly reduced until the pups were 4 weeks old, while in the male progeny of dams exposed to hydrogen chloride, functional disorders of lungs, kidneys and livers were seen in both exposure groups. Thus, Based on all the observations and results, it was concluded that the test chemical shows adverse effects on the test animals and the LOAEL for the test chemical was found to be 450 mg/m3.

Link to relevant study records

Reference

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Weight of evidence based on the data from test chemicals.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Principles of method if other than guideline:

The above experiment was performed to evaluate and assess the effects of the test chemical on the developmental parameters of the test chemical.

GLP compliance:

not specified

Specific details on test material used for the study:

- Molecular weight (if other than submission substance): 116.5239 g/mol
- Substance type: Inorganic
- Physical state: No Data Available
- Impurities (identity and concentrations): No Data Available

Species:

other: Study 2: Rat; Study 3: Mice

Strain:

other: Study 2: Wistar; Study 3: CF-1

Details on test animals or test system and environmental conditions:

Study 2: Details on test animals and env. conditions
TEST ANIMALS
- Source: No Data Available
- Age at study initiation: No Data Available
- Weight at study initiation: Female (180-200 g)
- Fasting period before study: No Data Available
- Housing:No Data Available
- Use of restrainers for preventing ingestion (if dermal): no
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data Available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No Data available
- Humidity (%): No Data available
- Air changes (per hr): No Data available
- Photoperiod (hrs dark / hrs light): No data available

Study 3: No Data Available

Route of administration:

other: Study 2 and 3: Inhalation

Type of inhalation exposure (if applicable):

other: Study 3: Whole Body

Vehicle:

not specified

Details on exposure:

Study 2: The females were exposed to (inhaled) the test chemical for 1 hour to 450 mg/m3.
Study 3: The test chemical was exposed the mice by inhalation route during Gestation Day 6 to 15 for 7 hours/day.

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

No Data Available

Details on mating procedure:

No Data Available

Duration of treatment / exposure:

Study 2: 1 hour
Study 3: 10 Days (7 hrs/day).

Frequency of treatment:

Study 2: Once
Study 3: Daily

Duration of test:

No Data Available

Remarks:

Study 2: 0 and 450 mg/m3 of the test chemical.
Study 3: 0, 5, 20 mg/m3 of the test chemical.

No. of animals per sex per dose:

Study 2: 8-15 animals
Study 3: No data Available

Control animals:

yes

Details on study design:

No Data Available

Maternal examinations:

Study 2: To assess the state of the mother tests reflecting the state of the lungs ( respiration rate, blood oxygen saturation, vital staining of the lung tissue , the liver, and the kidneys (diuresis, chlorides, protein) were used and the relative weights of the organs also were determined.

Study 3: Mean implants/dams, resorption/litter, Live fetuses were observed.

Ovaries and uterine content:

Study 2: No Data Available
Study 3: Impantations and Resorptions were observed.

Fetal examinations:

Study 2: In the observations on the progeny attention was paid to the number of fetuses in the litter , the postnatal mortality, and the changes in weight until the age of 4 weeks. At the age of 2 and 3 mouths the progenies (females and males separately) were studied by various function tests. To study lung function, exposure to hypoxia was used: The respiration rate was determined in a pressure chamber at an naltitude" of 3500 m and the blood oxygen saturation was determined when the [aspired air contained 10% oxygen.] During the investigation of hepatic and renal function of the progeny the same tests were used as on the mother. The oxygen consumption, the total serum protein, and the relative weights of the organs also were determined.

Study 3: Viability of the fetuses were observed.

Statistics:

No Data Available

Indices:

Study 2: No Data Available
Study 3: Implantation Index, Viability index

Historical control data:

No Data Available

Clinical signs:

effects observed, treatment-related

Description (incidence and severity):

Study 2: Severe signs of severe dyspnea and cyanosis was observed in all the treated animals.

Dermal irritation (if dermal study):

not specified

Mortality:

mortality observed, treatment-related

Description (incidence):

Study 2: Exposure to the test chemicaI caused death of one-third of the animals.

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

effects observed, treatment-related

Description (incidence and severity):

Study 2: On the 5th day after exposure the blood (mixed) oxygen saturation was lowered in treated pregnant rats as comp[ared to the control group.

Clinical biochemistry findings:

not specified

Urinalysis findings:

effects observed, treatment-related

Description (incidence and severity):

Study 2: An increase in the concentration of chlorides in the urine of the pregnant rats and also in the protein concentration in the urine as compared to the control group was observed.

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Description (incidence and severity):

Study 2: The relative weights of the organs in the experimental pregnant animals were indistinguishable from those of the controls.

Gross pathological findings:

effects observed, treatment-related

Description (incidence and severity):

Study 2: Injury to maternal organs, especially the endocrine glands, heart, and liver, during pregnancy was observed after exposure to the test chemical. The lungs of the dying rats were congested, with areas of edema and hemorrhage. Lung function was disturbed in the surviving females. Kidney function was disturbed in treated pregnant animals as compared to the control group. Changes in liver function were found in the pregnant animals.

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Number of abortions:

not specified

Pre- and post-implantation loss:

no effects observed

Description (incidence and severity):

Study 3: No effects were observed.

Total litter losses by resorption:

no effects observed

Description (incidence and severity):

Study 3: No effects were observed.

Early or late resorptions:

no effects observed

Description (incidence and severity):

Study 3: No effects were observed.

Dead fetuses:

effects observed, treatment-related

Description (incidence and severity):

Study 2: Observation on the development of the progeny showed an increase in mortality among the progeny of the rats of group exposed to the test chemical on the 9th day of pregnancy.

Study 3: Study 3: No effects were observed.

Changes in pregnancy duration:

not specified

Changes in number of pregnant:

not specified

Other effects:

not specified

Details on maternal toxic effects:

Study 2: Effects were observed in maternal animals after the exposure of the test chemical.
Study 3: No effects on mean numbers of implants/dam, live fetuses/litter or resorptions/litter were observed in mice.

Dose descriptor:

LOAEL

Effect level:

450 mg/m³ air

Based on:

test mat.

Basis for effect level:

clinical signs

dead fetuses

gross pathology

haematology

mortality

organ weights and organ / body weight ratios

Remarks on result:

other: Not Specified

Abnormalities:

not specified

Fetal body weight changes:

effects observed, treatment-related

Description (incidence and severity):

Study 2: The body weight of the fetuses after the exposure of the test chemical was reduced as compared to the control group.

Reduction in number of live offspring:

effects observed, treatment-related

Description (incidence and severity):

Study 2: An increase in mortality among the progeny of the rats of group exposed to the test chemical on the 9th day of pregnancy.
Study 3: No effects were observed.

Changes in sex ratio:

not specified

Changes in litter size and weights:

not specified

Changes in postnatal survival:

not specified

External malformations:

not specified

Skeletal malformations:

not specified

Visceral malformations:

not specified

Other effects:

effects observed, treatment-related

Description (incidence and severity):

Study 2: Investigation of the functions of the organs of the young rats aged 2 months showed a change in kidney functions in the progenies of both groups of rats. The diuresis was increased in the control group as compared to the control and a decrease in the protein content in the urine of the male progeny as compared to the control was observed.

Details on embryotoxic / teratogenic effects:

Study 2: Investigation of the functions of the organs of the young rats aged 2 months showed a change in kidney functions in the progenies of both groups of rats. The diuresis was increased in the control group as compared to the control and a decrease in the protein content in the urine of the male progeny as compared to the control was observed. An increase in mortality among the progeny of the rats of group exposed to the test chemical on the 9th day of pregnancy. The body weight of the fetuses after the exposure of the test chemical was reduced as compared to the control group.

Dose descriptor:

LOAEL

Effect level:

450 mg/m³ air

Based on:

test mat.

Sex:

male/female

Basis for effect level:

reduction in number of live offspring

fetal/pup body weight changes

Remarks on result:

other: Not Specified

Abnormalities:

not specified

Developmental effects observed:

not specified

Treatment related:

not specified

Conclusions:

Study 2: Based on all the observations and results, it was concluded that the test chemical shows adverse effects on the test animals and the LOAEL for the test chemical was found to be 450 mg/m3.

Study 3: Based on all the observations and results, it was concluded that the NOAEL for the maternal animals was 20 mg/m3 and the NOEL for the test chemical for fetal parameters was 20 mg/m3.

Executive summary:

Developmental Toxicity Studies:

The summaries of the developmental toxicity study are as follows:

Developmental Toxicity Study 2:

An inhalation study was performed to assess the effects of the test chemical on the reproductive and developmental toxicity on the test animals. In this study, 2 groups of 8–15 female rats were exposed to a concentration of 302 ml/m3 of the test chemical (450 mg/m3 ) for one hour. One group was exposed 12 days before and the other group 9 days after gestation. Both groups demonstrated symptoms of haemorrhagic oedema in the lungs, severe dyspnoe and cyanosis. One-third of the animals died. On the 5th day after exposure the blood (mixed) oxygen saturation was lowered in treated pregnant rats as comp[ared to the control group. An increase in the concentration of chlorides in the urine of the pregnant rats and also in the protein concentration in the urine as compared to the control group was observed. The relative weights of the organs in the experimental pregnant animals were indistinguishable from those of the controls. Injury to maternal organs, especially the endocrine glands, heart, and liver, during pregnancy was observed after exposure to the test chemical. The lungs of the dying rats were congested, with areas of edema and hemorrhage. Lung function was disturbed in the surviving females. Kidney function was disturbed in treated pregnant animals as compared to the control group. Changes in liver function were found in the pregnant animals. Fetal mortality was significantly increased in the group of rats which had been exposed during gestation. Among the progeny of dams which had been exposed 12 days prior to gestation, body weight gain was significantly reduced until the pups were 4 weeks old, while in the male progeny of dams exposed to hydrogen chloride, functional disorders of lungs, kidneys and livers were seen in both exposure groups. Thus, Based on all the observations and results, it was concluded that the test chemical shows adverse effects on the test animals and the LOAEL for the test chemical was found to be 450 mg/m3.

Developmental Toxicity Study 3:

An inhalation toxicity study was conducted on the CF-1 mice, to assess and evaluate the effects on the developmental parameters of the fetuses born to the maternal animals exposed to the test chemicals. In this study, time-mated maternal animals were exposed to the test chemical in the concentration of 0, 5, 20 mg/m3 during day 6 to 15 of gestation. The animals were exposed 7hours/day to the test chemical. In maternal parameters, mean implants/dams, resorption/litter, Live fetuses were observed. Also, viability of the fetuses were observed. After all the observations, it was seen that there was no significant effects on mean numbers of implants/dam, live fetuses/litter or resorptions/litter were observed in mice. Also, there were no difference in the viability of the pups when compared to the control group. Thus, based on all the observations and results, it was concluded that the NOAEL for the maternal animals was 20 mg/m3 and the NOEL for the test chemical for fetal parameters was 20 mg/m3.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LOAEC

450 mg/m³

Study duration:

chronic

Species:

rat

Quality of whole database:

Data is of Klimisch 4 database.

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

Developmental Toxicity Studies:

The summaries of the developmental toxicity study are as follows:

Developmental Toxicity Study 2:

An inhalation study was performed to assess the effects of the test chemical on the reproductive and developmental toxicity on the test animals. In this study, 2 groups of 8–15 female rats were exposed to a concentration of 302 ml/m3 of the test chemical (450 mg/m3 ) for one hour. One group was exposed 12 days before and the other group 9 days after gestation. Both groups demonstrated symptoms of haemorrhagic oedema in the lungs, severe dyspnoe and cyanosis. One-third of the animals died. On the 5th day after exposure the blood (mixed) oxygen saturation was lowered in treated pregnant rats as comp[ared to the control group. An increase in the concentration of chlorides in the urine of the pregnant rats and also in the protein concentration in the urine as compared to the control group was observed. The relative weights of the organs in the experimental pregnant animals were indistinguishable from those of the controls. Injury to maternal organs, especially the endocrine glands, heart, and liver, during pregnancy was observed after exposure to the test chemical. The lungs of the dying rats were congested, with areas of edema and hemorrhage. Lung function was disturbed in the surviving females. Kidney function was disturbed in treated pregnant animals as compared to the control group. Changes in liver function were found in the pregnant animals. Fetal mortality was significantly increased in the group of rats which had been exposed during gestation. Among the progeny of dams which had been exposed 12 days prior to gestation, body weight gain was significantly reduced until the pups were 4 weeks old, while in the male progeny of dams exposed to hydrogen chloride, functional disorders of lungs, kidneys and livers were seen in both exposure groups. Thus, Based on all the observations and results, it was concluded that the test chemical shows adverse effects on the test animals and the LOAEL for the test chemical was found to be 450 mg/m3.

Developmental Toxicity Study 3:

An inhalation toxicity study was conducted on the CF-1 mice, to assess and evaluate the effects on the developmental parameters of the fetuses born to the maternal animals exposed to the test chemicals. In this study, time-mated maternal animals were exposed to the test chemical in the concentration of 0, 5, 20 mg/m3 during day 6 to 15 of gestation. The animals were exposed 7hours/day to the test chemical. In maternal parameters, mean implants/dams, resorption/litter, Live fetuses were observed. Also, viability of the fetuses were observed. After all the observations, it was seen that there was no significant effects on mean numbers of implants/dam, live fetuses/litter or resorptions/litter were observed in mice. Also, there were no difference in the viability of the pups when compared to the control group. Thus, based on all the observations and results, it was concluded that the NOAEL for the maternal animals was 20 mg/m3 and the NOEL for the test chemical for fetal parameters was 20 mg/m3.

Justification for classification or non-classification

From all the above data, it is observed that the exposure of the test chemical to the experimental animals was multiple times more than the normal exposure to human population. Also, the normal route of exposure of the test chemical is niether through the inhalation, dermal and oral route. Thus, based on the information, the test chemical cannot be classified as a reproductive and developmental toxicant according to CLP regulation.