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Diss Factsheets

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)
Justification for type of information:
Carbon disulphide is a key metabolite of acid hydrolysis under gastric conditions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
not specified
Principles of method if other than guideline:
Gavage study on second species
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Carbon disulphide
EC Number:
200-843-6
EC Name:
Carbon disulphide
Cas Number:
75-15-0
Molecular formula:
CS2
IUPAC Name:
carbon disulfide
Constituent 2
Reference substance name:
Carbon disulfide
IUPAC Name:
Carbon disulfide
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on mating procedure:
Artificial insemination
Duration of treatment / exposure:
Daily from gestation day 6 to 19
Frequency of treatment:
Daily
Duration of test:
14 days
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
25 mg/kg bw/day (nominal)
Dose / conc.:
75 mg/kg bw/day (nominal)
Dose / conc.:
150 mg/kg bw/day (nominal)
No. of animals per sex per dose:
15
Control animals:
yes, concurrent no treatment
Details on study design:
Sacrifice on gestation day 30

Examinations

Maternal examinations:
Yes
Ovaries and uterine content:
Yes
Blood sampling:
No
Fetal examinations:
Yes
Statistics:
Yes
Historical control data:
Apparent references, but no details

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Across all groups, there was signs of post-treatment distress.
Mortality:
mortality observed, non-treatment-related
Description (incidence):
Some individual deaths across range of doses
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Reduced bodyweight gain in high dose animals
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Endocrine findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed

Maternal developmental toxicity

Number of abortions:
no effects observed
Pre- and post-implantation loss:
no effects observed
Total litter losses by resorption:
no effects observed
Dead fetuses:
no effects observed
Changes in number of pregnant:
no effects observed
Description (incidence and severity):
Pregnancy confirmed 88 - 96% wit no dose related differences.

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEL
Effect level:
75 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
body weight and weight gain
Dose descriptor:
LOAEL
Effect level:
150 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
body weight and weight gain

Results (fetuses)

Fetal body weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
Reduced average weights across all treatment levels, but not significant when compared with historical controls
Reduction in number of live offspring:
effects observed, non-treatment-related
Description (incidence and severity):
Reduced average weights across all treatment levels, but not significant when compared with historical controls
Changes in sex ratio:
no effects observed
Anogenital distance of all rodent fetuses:
no effects observed
Changes in postnatal survival:
not examined
External malformations:
no effects observed
Skeletal malformations:
effects observed, treatment-related
Description (incidence and severity):
A dose-related increase in the percentage of malformed foetuses observed
This was significant, when compared to controls, for the high dose group, but cose to historical controls

Effect levels (fetuses)

open allclose all
Dose descriptor:
NOAEL
Effect level:
75 mg/kg bw/day (nominal)
Based on:
test mat. (total fraction)
Sex:
male/female
Basis for effect level:
skeletal malformations
Dose descriptor:
LOAEL
Effect level:
150 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
skeletal malformations
Remarks on result:
other: not specified

Fetal abnormalities

Abnormalities:
not specified
Description (incidence and severity):
Details not provided in summary reports
Considered equivocal as close to historical controls

Overall developmental toxicity

Developmental effects observed:
not specified
Lowest effective dose / conc.:
75 mg/kg bw/day (nominal)
Treatment related:
yes

Applicant's summary and conclusion

Conclusions:
Adverse effects see at highest dose group of 150 mg/kg/day, but close to historical controls and at dose showing maternal toxicity (reduced body weight gain).
Details not provided in summary reports
Considered equivocal as close to historical controls