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Administrative data

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
120 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
7.5 mg/L
Study duration:
subchronic
Experimental exposure time per week (hours/week):
42
Species:
rat
Effect on fertility: via dermal route
Endpoint conclusion:
no adverse effect observed

Effects on developmental toxicity

Link to relevant study records
Reference
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:
data from handbook or collection of data
Justification for type of information:
Carbon disulphide has been demonstrated to form during hydrolysis in gastric fluid.
Any oral toxicity on the xanthate needs to consider oral effects of carbon disulphide and the corresponding alcohol
Data access has been requested, but this summary is extracted from disseminated information published by ECHA
Further animal testing on the xanthate cannot be justified
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
not specified
Remarks:
Pre-dates widespread introduction of GLP Data set considered valid
Limit test:
no
Species:
rat
Strain:
other: CD
Details on test animals or test system and environmental conditions:
Age 8 - 12 weeks at start of study
Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
Co-habitation 1:!
Duration of treatment / exposure:
Gestation day 6 to 15
Frequency of treatment:
Daily
Duration of test:
From gestation day 6 to 15
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
100 mg/kg bw/day (nominal)
Dose / conc.:
200 mg/kg bw/day (nominal)
Dose / conc.:
400 mg/kg bw/day (nominal)
Dose / conc.:
600 mg/kg bw/day (nominal)
No. of animals per sex per dose:
Up to 27
Control animals:
yes, concurrent no treatment
Maternal examinations:
Clinical signs daily after exposure
Ovaries and uterine content:
Yes
Blood sampling:
Not specified
Fetal examinations:
Yes; external, visceral, skeletal and head
Statistics:
As needed
Historical control data:
Not specified
Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Lethargy, ataxia, abnormal posture and rough coat
Mortality:
mortality observed, non-treatment-related
Description (incidence):
One female, mid dose
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Decrease in body weight for highest doses
Food consumption and compound intake (if feeding study):
not specified
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
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
Increased liver weights in higher dose groups
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
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 pregnancy duration:
not examined
Other effects:
no effects observed
Dose descriptor:
NOAEL
Effect level:
100 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
body weight and weight gain
organ weights and organ / body weight ratios
Remarks on result:
other: Toxicological significance of maternal effects not specified
Fetal body weight changes:
effects observed, treatment-related
Description (incidence and severity):
Weight decrease in highest dose groups
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
no effects observed
Changes in litter size and weights:
effects observed, treatment-related
Description (incidence and severity):
Reduced weights of litters at higher doses, mirroring maternal effect
Changes in postnatal survival:
no effects observed
External malformations:
effects observed, non-treatment-related
Description (incidence and severity):
Across various dose levels and within historical control
Skeletal malformations:
effects observed, non-treatment-related
Description (incidence and severity):
Across various dose levels and within historical control
Visceral malformations:
effects observed, non-treatment-related
Description (incidence and severity):
Across various dose levels and within historical control
Dose descriptor:
NOAEL
Effect level:
100 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
fetal/pup body weight changes
Abnormalities:
effects observed, non-treatment-related
Localisation:
other: Various changes - no obvious significance
Description (incidence and severity):
Various effects observed but within historical levels.
Developmental effects observed:
no
Conclusions:
Oral treatment produced dose-related maternal and foetal toxicity at 200 mg/kg bw/day or higher.
There was no increase in the incidence of malformed foetuses.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
100 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEC
10 mg/L
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Additional information