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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

NOAEL oral subacute toxicity = 50 mg/kg bw

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessed after consultation with the relevant Authority. Data migrated from NONS (67/548/EEC notification) files provided by Authority contained insufficient information.
according to guideline
other: Guidelines for Chemical Substances Control Law of Japan (1986)
GLP compliance:
No further information was provided in the SNIF file.
Limit test:
other: Charles River CD(R)
Route of administration:
oral: unspecified
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Test duration: 28 days, including an unspecified recovery period.
Frequency of treatment:
Dosing regime: 7 days/week
Doses / Concentrations:
0, 10, 50, 200 mg/kg bw/day
no data
No. of animals per sex per dose:
Control: 5
10 mg/kg bw/day: 5
50 mg/kg bw/day: 5
200 mg/kg bw/day: 10
Control animals:
Clinical signs:
effects observed, treatment-related
mortality observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Haematological findings:
effects observed, treatment-related
Gross pathological findings:
effects observed, treatment-related
Details on results:
Poor food efficiency during exposure in the 200 mg/kg bw/day groups. During the post-exposure period the food efficiency was normal.

Males in the 200 mg/kg bw/d group had a slightly increased erythrocyte level. Irregularities in the blood values of male and female animals were
observed. The prothrombin time was longer in the 200 mg/kg bw/d dose groups and in males dosed with 50 mg/kg bw/d.

Increased liver weight in animals dosed with 200 mg/kg bw/d.

No deviations were reported.
Dose descriptor:
Effect level:
50 mg/kg bw/day (nominal)
Based on:
not specified
Basis for effect level:
other: Original NCD unit is mg/kg/day
Critical effects observed:
not specified
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
50 mg/kg bw/day
Study duration:
Quality of whole database:
Reliable quality

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

One subacute 28 -day oral toxicity study was performed according to the Guidelines for chemical substances control law of Japan (1985) and under GLP conditions ( Mitsui 1993, SNIF#001-4.2.10 -01). The details of the guideline requirements and the study methods are not available. Charles River CD(R) rats were exposed via an unspecified oral route to 0, 10, 50 or 200 mg/kg bw/d in corn oil. Considering the vehicle that was used, it is reasonable to assume the test substance was administered by gavage.

Poor food efficiency was noted during the exposure period in the highest dose group (200 mg/kg bw/d). The food efficiency measured during the recovery period (of unknown length) was normal, which may indicate that dosing of the test substance per se reduced food uptake. In the 200 mg/kg bw/d group, an increase in prothrombin time and other unspecified irregularities in the haematologic values were observed in both males and females. The prothrombin time was also increased in males in the 50 mg/kg bw/d group, but this was not considered to be an adverse effect as no additional haematological or other effects were observed at this dose level, in either sex. A slight increase in liver weight was reported in animals in the highest dose group. It is likely that this is a response to increased metabolic activity in the liver, as no corresponding histopathologic changes were observed. Based on the changes in haematologic values the NOAEL is considered to be 50 mg/kg bw/d.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Key study

Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: other

Justification for classification or non-classification

According to Annex I of DSD (67/548/EC), 2,3-bis((mercaptoethyl)thio)-1-propanethiol is classified as Xn, R48/22.

According to Annex VI of CLP (1272/2008/EC), 2,3 -bis((mercaptoethyl)thio)-1 -propanethiol is classified as STOT-RE 2.