Registration Dossier

Administrative data

Description of key information

Only limited information is available regarding acute toxicity of the test item.
Oral LD50 values for mouse, rat and rabbit indicate an oral toxicity of the test item in the range of 383-938 mg/kg bw (LD50).

This result is supported by a guideline study on mixed xylenols with an oral LD50 of 980 mg/kg bw (ECHA disseminated dossier CAS: 1300 -71 -6).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data from collection of data, no details on methods and results
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Details on oral exposure:
not specified
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
444 mg/kg bw
Interpretation of results:
sligthly toxic
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
444 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the NTP data base and the repository for the test item several LD50 values are specified without detailed information:

LD 50 oral mouse: 383 mg/kg bw

LD 50 oral rat: 444 mg/kg bw

LD 50 oral rabbit: 938 mg/kg bw


Justification for selection of acute toxicity – oral endpoint
Only supporting study data available.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008:

Based on the available data the substance is considered to be classified for acute oral toxicity as Acute Tox Cat 4 , H302 under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC 605/2014.

As the test item is officially classified as Acute Tox 3, H301 and H311 under Regulation (EC) No 1272/2008 (Annex VI), as amended for the sixth time in Regulation EC 605/2014, this classification is followed.

Aspiration is a known hazard of hydrocarbons and classification is based on the physical characteristics and therefore classification with Cat.1, H304 "May be fatal if swallowed and enters airways" is warranted.