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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute toxicity testing was waived based upon the skin corrosive classification of the substance, however the European Commison has previous reviewed existing data on the substance and assigned the following harmonised classification and labelling: Toxic if swallowed (H301) and Harmful in contact with the skin (H312).

The following reliable oral toxicity values are presented in the literature: Mouse LD50 100mg/kg bw (Lewis, RL, 2005); rat LD50 110 mg/kg bw (Lewis RL, 2005) and rat LD50 140 mg/kg bw (Smyth et al, 1962), confirming the harmonised classification for oral toxicity.

A single reliable dermal toxicity value is available in the literature, an LD50 of 800 mg/kg bw in rabbits (Smyth et al, 1962), which supports the harmonised classification for dermal toxicity.

A harmonised classification for inhalation toxicity has not been assigned, however based upon the weight of evidence of human occupational toxicity (Shiozaki et al, 1994) and a reliable inhalation toxicity value in mice of 0.66 mg/L (Smyth et al 1962) a classification of Fatal if inhaled (H330) can reasonably be assigned.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
peer reviewed data published in handbook
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 100 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 3 based on GHS criteria
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
peer reviewed data in a collection/handbook
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 110 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 3 based on GHS criteria
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
peer reviewed data in a collection/handbook
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 140 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 3 based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
100 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: report of occupational exposure
Qualifier:
no guideline required
Principles of method if other than guideline:
Report of result of occupational exposure to the substance
GLP compliance:
no
Remarks:
Occupational exposure
Test type:
other: Occupational exposure
Limit test:
no
Species:
other: human
Sex:
male
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Sex:
male
Dose descriptor:
other: mortality following occupational exposure
Remarks on result:
other: mortality following occupational exposure
Mortality:
Two of the five died from hepatic failure four and 11 days after the job
Gross pathology:
Autopsy showed
submassive hepatocellular necrosis in one of the individuals
Other findings:
In five of 12 workers exposed to an unknown concentration of 1,3-DCP (via inhalation) from the
cleaning of a saponification tank used in the manufacture of 1,3-DCP, acute hepatitis developed.

In five of 12 workers exposed to an unknown concentration of 1,3-DCP (via inhalation) from the

cleaning of a saponification tank used in the manufacture of 1,3-DCP, acute hepatitis developed.

Two of the five died from hepatic failure four and 11 days after the job. Autopsy showed

submassive hepatocellular necrosis in one of the individuals (e.g., total bilirubin levels were

significantly increased). At ~48 hours after exposure, the 1,3-DCP plasma level was 200 ng/mL.

Potential exposure to other chemicals was not reported

Interpretation of results:
other: mortality following occupational expoaure
Conclusions:
In five of 12 workers exposed to an unknown concentration of 1,3-DCP (via inhalation) from the
cleaning of a saponification tank used in the manufacture of 1,3-DCP, acute hepatitis developed.
Two of the five died from hepatic failure four and 11 days after the job. Autopsy showed
submassive hepatocellular necrosis in one of the individuals. The substance is toxic by inhalation and/or dermal exposure.
Endpoint:
acute toxicity: inhalation
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
Qualifier:
no guideline available
Principles of method if other than guideline:
Peer reviewed data published in a collection of data
GLP compliance:
no
Remarks:
colleciton of data
Test type:
traditional method
Limit test:
no
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
not specified
Duration of exposure:
ca. 4 h
Sex:
not specified
Dose descriptor:
LC50
Effect level:
ca. 0.66 mg/L air
Based on:
not specified
Exp. duration:
4 h
Interpretation of results:
Category 2 based on GHS criteria
Conclusions:
Based on the LC50 of 0.66 mg/L/4 hours exposure the substance is classified as Acute toxicity (inhalation) Category 2.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
660 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline available
Principles of method if other than guideline:
The study was reported in a collection of published data
GLP compliance:
no
Remarks:
collection of data published
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 800 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The results of the study indicate that classification as Acute toxicity Category 3 may be justified- the European Commission has assigned a harmonised classification of Acute toxicity (dermal) category 4
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
800 mg/kg bw

Additional information

Justification for classification or non-classification

Acute toxicity testing was waived based upon the skin corrosive classification of the substance, however the European Commison has previous reviewed existing data on the substance and assigned the following harmonised classification and labelling: Toxic if swallowed (H301) and Harmful in contact with the skin (H312).

The following reliable oral toxicity values are presented in the literature: Mouse LD50 100mg/kg bw (Lewis, RL, 2005); rat LD50 110 mg/kg bw (Lewis RL, 2005) and rat LD50 140 mg/kg bw (Smyth et al, 1962), confirming the harmonised classification for oral toxicity.

A single reliable dermal toxicity value is available in the literature, an LD50 of 800 mg/kg bw in rabbits (Smyth et al, 1962), which supports the

harmonised classification for dermal toxicity.

A harmonised classification for inhalation toxicity has not been assigned, however based upon the weight of evidence of human occupational toxicity (Shiozaki et al, 1994) and a reliable inhalation toxicity value in mice of 0.66 mg/L (Smyth et al 1962) a classification of Fatal if inhaled (H330) can reasonably be assigned.