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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Literature study, comparable to OECD 414

Data source

Reference
Reference Type:
publication
Title:
Embryotoxicity of inhaled sulfuric acid aerosol in mice and rabbits
Author:
Murray FJ, Schwetz BA, Nitschke KD, Crawford AA, Quast JF & Staples RE
Year:
1979
Bibliographic source:
J Environ Sci Health (Part C) 13(3): 251-66

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
yes
Remarks:
Number of exposure levels
Principles of method if other than guideline:
Sulphuric acid was tested by inhalation for embryotoxicity in rabbits according to a protocol similar to OECD guideline 414
GLP compliance:
no
Remarks:
Older, published study
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sulphuric acid
EC Number:
231-639-5
EC Name:
Sulphuric acid
Cas Number:
7664-93-9
Molecular formula:
H2O4S
IUPAC Name:
sulfuric acid
Details on test material:
Aerosols were generated for each chamber by nebulising 2M sulphuric acid (95.7%)

Test animals

Species:
rabbit
Strain:
other: New Zealand White, CF-1

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure (if applicable):
whole body
Vehicle:
water
Analytical verification of doses or concentrations:
yes
Details on mating procedure:
Nulliparous female rabbits were artificially inseminated. The day on which rabbits were artificially inseminated was considered day zero of gestation.
Duration of treatment / exposure:
7 hours/day: Day 6-18 of gestation
Frequency of treatment:
Daily
Duration of test:
Day 29 of gestation
No. of animals per sex per dose:
20 (with controls)
Control animals:
yes

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

open allclose all
Dose descriptor:
LOAEC
Effect level:
19.3 mg/m³ air (analytical)
Basis for effect level:
other: Maternal toxicity
Dose descriptor:
NOAEC
Effect level:
5.7 mg/m³ air (analytical)
Basis for effect level:
other: Maternal toxicity
Dose descriptor:
NOAEC
Effect level:
19.3 mg/m³ air (analytical)
Basis for effect level:
other: Developmental toxicity

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEC
Effect level:
19.3 mg/m³ air (analytical)
Basis for effect level:
other: Teratogenicity

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Inhalation of 5 or 20 mg sulphuric acid/m3 did cause any signs of toxicity.  The incidence of pregnancy was not significantly altered among rabbits. In rabbits, a statistically significant decrease in maternal bodyweight gain was noted during the first few days of exposure to 20 mg/m3.  The liver weight of dams was unaltered by exposure to sulphuric acid in rabbits.  Evidence of toxicity that could be attributed to sulphuric acid was observed in the respiratory tract in rabbits, as a  trend toward a dose-related increase in the incidence of subacute rhinitis and tracheitis was noted.  The mean numbers of implants/dam, live foetuses/litter, or resorptions/litter were not significantly altered by exposures.  No significant effect on foetal sex ratio was seen.  Mean weights and lengths of the offspring of rabbits exposed to sulphuric acid were not significantly different from their respective control values.  The offspring of rabbits exposed to sulphuric acid did not have a significantly higher incidence of malformations than controls.  In rabbits, an increased incidence of small non-ossified areas in the skull bones (a minor variation) was the only statistically significant evidence of embryotoxicity observed among the offspring of rabbits exposed to 20 mg/m3.

Applicant's summary and conclusion

Conclusions:
No evidence of teratogenicity, embryotoxicity, foetotoxicity or developmental toxicity was seen under the conditions of this study, at exposure levels sufficient to cause mild maternal toxicity.
Executive summary:

Inseminated female rabbits were exposed (whole body) to atmospheres containing aerosols of sulphuric acid at 0, 5.7 mg/m3 (MMAD 1.6 um) or 19.3 mg/m3 (MMAD 2.4 um) on Days 6 -18 of gestation (rabbits). Animals were sacrificed at Day 29 of gestation (rabbits). Evidence of mild toxicity was seen in maternal rabbits (reduced weight gain, respiratory tract effects) at 20 mg/m3. No evidence of teratogenicity or developmental toxicity was seen.

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