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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

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.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
reproductive toxicity, other
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:
Data is from a secondary literature source.
Qualifier:
no guideline available
Principles of method if other than guideline:
The above experiment was performed to evaluate and assess the effect of the test chemical on the reproductive toxicity of the test animals.
GLP compliance:
not specified
Justification for study design:
No Data Available
Specific details on test material used for the study:
Details on test material
- Molecular weight (if other than submission substance): 36.5 g/mol
- Substance type: Inorganic
- Physical state: Liquid
- Impurities (identity and concentrations): No Data Available
Species:
rat
Strain:
not specified
Details on species / strain selection:
No data available
Sex:
female
Details on test animals or test system and environmental conditions:
No data Available
Route of administration:
inhalation: aerosol
Type of inhalation exposure (if applicable):
not specified
Mass median aerodynamic diameter (MMAD):
other: Not Specified
Vehicle:
not specified
Details on exposure:
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.
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:
12 days before gestation and 9 days after gestation.
Frequency of treatment:
No Data Available
Details on study schedule:
No Data Available
Remarks:
0 and 302 ml/m3 (450 mg/m3) of the test chemical.
No. of animals per sex per dose:
8-15 female rats
Control animals:
yes
Details on study design:
No data Available
Positive control:
No Data Available
Parental animals: Observations and examinations:
Clinical Signs and Mortality was observed.
Oestrous cyclicity (parental animals):
No Data Available
Sperm parameters (parental animals):
No data Available
Litter observations:
Clinical Signs, Mortality and body weight of the fetus was observed
Postmortem examinations (parental animals):
Gross Necropsy was performed.
Postmortem examinations (offspring):
Gross Necropsy of the offsprings was performed.
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):
Dyspnoe and cyanosis was observed in all the treated animals.
Dermal irritation (if dermal study):
not specified
Mortality:
mortality observed, treatment-related
Description (incidence):
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:
not specified
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
No Data Available
Dose descriptor:
LOAEL
Effect level:
450 mg/m³ air
Based on:
test mat.
Sex:
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):
Fetal mortality was significantly increased in the group of rats which had been exposed during gestation.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
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
Haematological 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):
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
No data Available
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:
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.
Executive summary:

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.

Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
reproductive toxicity, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from a handbook or a collection of data.
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD 414: PreNatal Developmental Toxicity Screening Test
Principles of method if other than guideline:
The above experiment was performed to assess and evaluate the effects of the test chemicals on the reproductive and developmental parameters of the test animals.
GLP compliance:
not specified
Justification for study design:
No Data Available
Specific details on test material used for the study:
Details on test material
- Molecular weight (if other than submission substance): 98.0778 g/mol
- Substance type: Inorganic
- Physical state: Liquid
- Impurities (identity and concentrations): No data available
Species:
mouse
Strain:
CF-1
Details on species / strain selection:
NO Data Available
Sex:
female
Details on test animals or test system and environmental conditions:
No Data Available
Route of administration:
inhalation
Type of inhalation exposure (if applicable):
whole body
Vehicle:
not specified
Details on exposure:
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:
10 days.
Frequency of treatment:
Once (7 hours/Day)
Details on study schedule:
No Data available
Remarks:
0, 5, 20 mg/m3 of the test chemical.
No. of animals per sex per dose:
No data available
Control animals:
yes
Details on study design:
No Data Available
Positive control:
No Data Available
Parental animals: Observations and examinations:
Mean Implantation, Resorptions per litter were observed.
Oestrous cyclicity (parental animals):
No Data Available
Sperm parameters (parental animals):
No Data Available
Litter observations:
Viability of the litters were observed.
Postmortem examinations (parental animals):
Implantations and Resorptions of females were counted.
Postmortem examinations (offspring):
No Data Available
Statistics:
No Data Available
Reproductive indices:
Implantation Index, Resorption Index
Offspring viability indices:
Viability Index.
Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
not specified
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):
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:
no effects observed
No significant effects on mean numbers of implants/dam, and resorptions/litter were observed in mice.
Dose descriptor:
NOAEL
Effect level:
20 mg/m³ air
Based on:
test mat.
Sex:
female
Basis for effect level:
gross pathology
histopathology: non-neoplastic
reproductive performance
Remarks on result:
other: Not Specified
Critical effects observed:
not specified
System:
other: No Data Available
Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality / viability:
no mortality observed
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
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified
Other effects:
not specified
Behaviour (functional findings):
not specified
Developmental immunotoxicity:
not specified
No effects and viabilty of the fetus and other fetotoxicity of the test chemical.
Dose descriptor:
NOEL
Generation:
F1
Effect level:
20 mg/m³ air
Based on:
test mat.
Sex:
male/female
Basis for effect level:
viability
Remarks on result:
other: Not Specified
Reproductive effects observed:
not specified
Treatment related:
not specified
Conclusions:
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:

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.

Data source

Referenceopen allclose all

Reference Type:
other: Assessment Report
Title:
Unnamed
Year:
2001
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Chlorosulphuric acid
EC Number:
232-234-6
EC Name:
Chlorosulphuric acid
Cas Number:
7790-94-5
Molecular formula:
ClHO3S
IUPAC Name:
sulfurochloridic acid
Test material form:
not specified
Details on test material:
Details on test material
- Name of test material (as cited in study report): Chorosulfuric Acid
- Molecular formula (if other than submission substance): Cl-H-O3-S
- 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
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

Test animals

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

Administration / exposure

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
Doses / concentrations
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

Examinations

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

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

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 / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
not specified

Details on results (P0)

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.

Effect levels (P0)

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

Target system / organ toxicity (P0)

Critical effects observed:
not specified
System:
other: Not Specified

Results: F1 generation

General toxicity (F1)

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

Developmental neurotoxicity (F1)

Behaviour (functional findings):
not specified

Developmental immunotoxicity (F1)

Developmental immunotoxicity:
not specified

Details on results (F1)

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.

Effect levels (F1)

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.

Target system / organ toxicity (F1)

Critical effects observed:
not specified
System:
other: Not Specified

Overall reproductive toxicity

Reproductive effects observed:
not specified
Treatment related:
not specified

Applicant's summary and conclusion

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.